Latest News - Neuro News Affino Atom Generator BIBA Medical Ltd 2014-07-31T12:27:20Z Medtronic completes acquisition of Visualase 2014-07-28T14:54:00Z 2014-07-28T14:54:00Z <div id="Introduction1" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Medtronic has announced that it has completed the acquisition of Visualase, a&nbsp;privately held company based in Houston, USA, that develops and markets an FDA-approved MRI-guided laser and image guided system for minimally invasive neurosurgeries, including surgical thermal ablation.</strong></span></p> </div><div id="Text11" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Medtronic will add Visualase&rsquo;s MRI-guided laser ablation system to its portfolio of therapies for treating neurological conditions within its Surgical Technologies business and will integrate the technology into its broader neuroscience offerings. The acquisition of Visualase is another example of Medtronic&rsquo;s ongoing investment in technology and commitment to innovation across the entire surgical care continuum as the company strives to become the partner of choice for neurosurgeons and neuroscience centres around the world.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are excited about this opportunity to add Visualase&rsquo;s complementary technology and expertise to our neurosurgical solutions portfolio, which includes intra-operative imaging, surgical navigation, powered instruments and cerebrospinal fluid (CSF) management,&rdquo; says Mark Fletcher, senior vice president and president, Medtronic Surgical Technologies. &ldquo;The Visualase laser ablation technology gives neurosurgeons a minimally invasive option to precisely target and treat small areas of tissues. We are the recognised leader in high technology solutions for specialties such as neurosurgery, spinal surgery and orthopaedics. This acquisition broadens our strong and growing portfolio of innovative surgical products and represents entries into new areas such as surgical thermal ablation.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The transaction with Medtronic is critical to ensure more patients have access to our beneficial technology,&rdquo; says William Hoffman, chief executive officer of Visualase. &nbsp;&ldquo;We are proud of the MRI-guided laser ablation technology and other products we have developed and their impact on the well-being of patients. Medtronic is clearly committed to the area of minimally invasive neurosurgery and we look forward to working as a team to innovate in this area.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The all-cash transaction of up to US$105 million includes an initial payment of US$70 million plus additional payments of up to US$35 million which are contingent upon the achievement of specific milestones.&nbsp;Medtronic had previously invested in Visualase and held an ownership stake in the company prior to completion of the acquisition.&nbsp;Net of this ownership stake, the initial payment is approximately US$64 million.&nbsp;Medtronic expects the net impact from this transaction to be neutral to fiscal year 2015 earnings and accretive thereafter, and for this transaction to be consistent with the company&rsquo;s disciplined focus on long-term returns.&nbsp;</span></p></div> IMRIS receives CE mark for integrating latest generation MR scanners within VISIUS surgical theatre 2014-07-28T12:13:00Z 2014-07-28T12:13:00Z <div id="ImageMain2" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction2" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS has announced that it has obtained regulatory CE mark for integrating the next generation MRI core technology into the VISIUS surgical theatre allowing for sales and marketing in the European Union.</strong></span></p> </div><div id="Text12" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This newest imaging technology, based on the Siemens Aera 1.5T(tesla) and Skyra 3.0T MRI scanners, helps IMRIS deliver even better image quality, faster 3D image acquisition, and improved ease-of-use and workflow during surgical procedures using intraoperative MRI (iMRI). The company received United States Food and Drug Administration (FDA) approval for these advancements in February 2014.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These high-field intraoperative scanner options will give a hospital&rsquo;s clinical team state-of-the-art applications and image quality that increase productivity,&rdquo; says IMRIS president and chief executive officer Jay D Miller. &ldquo;We bring the latest and unequaled imaging technology into the operating room where it can make the most difference - during the surgery. More and more neurosurgical centres are using image guidance with VISIUS iMRI for an expanding list of conditions and procedures and adjunctive interventions beyond brain tumour resections, such as laser ablation for tumours and epilepsy using stereotactic tools, deep brain stimulation (DBS) and other minimally-invasive techniques that are designed to improve patient outcomes.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Inside a VISIUS surgical theatre equipped with high-field iMRI, surgeons have on-demand access to real-time data and state-of-the-art imaging during the procedure as the scanner uniquely moves on ceiling-mounted rails.</span></p></div> NeuroPace RNS system will play key role in DARPA’s RAM programme 2014-07-24T12:33:00Z 2014-07-24T12:33:00Z <div id="ImageMain3" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction3" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroPace has announced its partnership with the Defense Advanced Research Projects Agency (DARPA) Restoring Active Memory (RAM) teams at the University of Pennsylvania and the University of California, Los Angeles (UCLA), USA to develop new treatments for memory deficits using neurostimulation.</strong></span></p> </div><div id="Text13" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The RNS system is the world&rsquo;s only commercially available implantable closed-loop responsive neurostimulator system. NeuroPace received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the RNS System in November 2013. It is approved as a treatment for adults with partial onset seizures with one or two seizure onset zones whose seizures have not been controlled with two or more antiepileptic drugs.</span></p> <p><br /><span style="font-size: 10pt;">Through the DARPA RAM research, NeuroPace and other collaborators will gain fundamental knowledge regarding the restoration of memory. The company believes this research may expand the clinical applications of the RNS system beyond the treatment of epilepsy, as well as provide the understanding necessary to inform the development of future devices that expand the capabilities of responsive neurostimulation. This collaborative effort will advance the field of brain research and closed-loop neurostimulation applications. A portion of the DARPA project will involve epilepsy patients implanted with the RNS system at seven Comprehensive Epilepsy Centers and will be led by Barbara Jobst, professor of Neurology at Dartmouth, and Martha Morrell, chief medical officer at NeuroPace and clinical professor of Neurology at Stanford University. A separate part of the project will begin with epilepsy patients implanted with the RNS system at UCLA with Itzhak Fried serving as the principal investigator.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Using the RNS system, we will be able to immediately explore ways in which brain stimulation can restore memory function in patients with epilepsy. Insights derived from these early studies will help to guide future research in patients with other neurological disorders that result in memory loss,&rdquo; says Michael Kahana, principal investigator at the University of Pennsylvania.</span></p> <p><br /><span style="font-size: 10pt;">As a closed-loop system, the RNS system monitors the brain&rsquo;s own signals, interprets those signals, provides stimulation when needed, and then assesses the brain&rsquo;s response. The breakthrough aspect of the RNS system is its advanced detection and stimulation capabilities. This is unlike all other existing neurostimulation therapies, which continuously or intermittently stimulate the brain without determining the need for treatment or monitoring the response.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The RNS system is the only commercially available product that continuously monitors the brain&rsquo;s electrical signals, delivers stimulation only when needed and then monitors the response,&rdquo; says Frank Fischer, chief executive officer at NeuroPace. &ldquo;This capability is critical to the research phase of projects like the DARPA RAM programme. Restoring active memory could improve the lives of so many. We are thrilled to be a part of this programme and hope to be part of similar brain research and product development projects in the future.&rdquo;</span></p></div> Plegridy (peginterferon beta-1a) approved in the EU for treatment of multiple sclerosis 2014-07-23T12:51:00Z 2014-07-23T12:51:00Z <div id="Introduction4" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Biogen Idec&nbsp;has announced that the European Commission has granted marketing authorisation for Plegridy&nbsp;(peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). Plegridy is dosed once every two weeks and is administered subcutaneously with the Plegridy pen, a new ready-to-use autoinjector, or a prefilled syringe.</strong></span></p> </div><div id="Text14" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Plegridy, the only pegylated interferon approved for use in relapsing-remitting multiple sclerosis, has been proven to significantly reduce important measures of disease activity, including number of relapses, MRI brain lesions, and disability progression.</span></p> <p><br /><span style="font-size: 10pt;">The European Commission approval of Plegridy is based on results from one of the largest pivotal studies of a beta interferon conducted, <a href=";rank=13" target="_blank"><strong>ADVANCE</strong></a>, which involved more than 1,500 patients with relapsing forms of multiple sclerosis.</span></p> <p><br /><span style="font-size: 10pt;">In the ADVANCE clinical trial, Plegridy, dosed once every two weeks, significantly reduced annualised relapse rate (ARR) at one year by 36% compared to placebo (p=0.0007).</span></p> <p><br /><span style="font-size: 10pt;">Plegridy reduced the risk of sustained disability progression confirmed at 12 weeks by 38% (p=0.0383) and at 24 weeks by 54% (p=0.0069, post-hoc analysis). In addition, the number of gadolinium-enhancing [Gd+] lesions was significantly reduced by 86% (p&lt;0.0001) compared to placebo.</span></p> <p><span style="font-size: 10pt;"><br />Results over two years of ADVANCE confirm that its robust efficacy was maintained beyond the placebo-controlled first year of the study.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The safety and efficacy that Plegridy has demonstrated, combined with its less frequent dosing schedule offers multiple sclerosis patients an option to put their treatment in the background for longer stretches of time,&rdquo; says Bernd C Kieseier, Heinrich-Heine&nbsp;Universit&auml;t, Dusseldorf.</span></p> <p><br /><span style="font-size: 10pt;">The safety and tolerability profile of peginterferon beta-1a observed in ADVANCE&nbsp;was consistent with that of established multiple sclerosis interferon therapies. The most commonly reported adverse drug reactions with peginterferon beta-1a treatment (incidence &ge;10% and at least 2% more frequent on peginterferon beta-1a than on placebo) were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching, and joint pain.</span></p> <p><br /><span style="font-size: 10pt;">Plegridy is the fifth therapy to be offered by Biogen Idec to people living with multiple sclerosis.</span></p></div> US$1 million Career Development Award grant for glioblastoma research with ThermoDox and HIFU 2014-07-22T10:14:00Z 2014-07-22T10:14:00Z <div id="Introduction5" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Celsion Corporation has announced that its ongoing collaboration with Costas Arvanitis of Brigham and Women&rsquo;s Hospital, a teaching affiliate of&nbsp;Harvard Medical School, has been expanded through the recent award of a&nbsp;US$1 million&nbsp;Career Development Award from the National Institutes of Health&rsquo;s Center for Biomedical Imaging and Bioengineering (NIBIB).</strong></span></p> </div><div id="Text15" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The grant will support preclinical studies evaluating ThermoDox, the company&rsquo;s heat-activated liposomal encapsulation of doxorubicin, in combination with High Intensity Focused Ultrasound (HIFU), for the treatment of brain tumours. The grant, titled &ldquo;Controlled Delivery and Release of Chemotherapy in Brain Tumours with FUS&rdquo; provides on average of&nbsp;US$200,000&nbsp;in annual funding for five years, and will be used to advance preclinical development of ThermoDox for the treatment of brain cancers, including glioblastoma multiforme, under the company&rsquo;s&nbsp;January 2014&nbsp;collaboration with Brigham and Women&rsquo;s Hospital, Harvard Medical School.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This peer-reviewed grant award builds upon our ongoing collaborative work to explore treatments for brain tumours,&rdquo; says Costas D Arvanitis, Brigham and Women&rsquo;s Hospital,&nbsp;Harvard Medical School. &ldquo;Delivering chemotherapeutic agents across the blood-brain barrier is particularly challenging, but in recent years we have discovered that this could be achieved using focused ultrasound, including enhanced delivery of liposomal doxorubicin.&nbsp;We are hopeful that this grant will allow us to determine the potential utility of a promising therapeutic application for one of the most insidious cancers - glioblastoma.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Glioblastoma is a highly aggressive and deadly form of brain cancer for which there are few treatment options,&rdquo; says&nbsp;Michael H Tardugno, Celsion&rsquo;s president and chief executive officer.&nbsp;&ldquo;Working with a prominent cancer research group like Dr Arvanitis and his team, combined with the financial support of the NIH, will help accelerate the research required to elucidate the potential of ThermoDox combined with HIFU in this difficult to treat cancer, and provide a path forward for larger, more comprehensive phase II studies.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">If promising results are obtained from these phase I studies, a phase II grant application will be submitted to include more comprehensive studies of ThermoDox and HIFU for the treatment of glioblastoma multiforme brain tumours.</span></p></div> Study links enzyme to Alzheimer’s disease 2014-07-21T15:54:00Z 2014-07-21T15:54:00Z <div id="ImageMain6" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction6" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Unclogging the body&rsquo;s protein disposal system may improve memory in patients with Alzheimer&rsquo;s disease, according to a study from scientists at Kyungpook National University in Korea published in&nbsp;<a href="" target="_blank"><em>The Journal of Experimental Medicine</em></a>.</strong></span></p> </div><div id="Text16" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In Alzheimer&rsquo;s disease, various biochemical functions of brain cells go awry, leading to progressive neuronal damage and eventual memory loss. One example is the cellular disposal system, called autophagy, which is disrupted in patients with Alzheimer&rsquo;s disease, causing the accumulation of toxic protein plaques characteristic of the disease. Jae-sung Bae and colleagues had earlier noted that the brains of Alzheimer&rsquo;s disease patients have elevated levels of an enzyme called acid sphingomyelinase (ASM), which breaks down cell membrane lipids prevalent in the myelin sheath that coats nerve endings. But whether increased acid sphingomyelinase directly contributes to Alzheimer&rsquo;s disease (and if so, how) was unclear.</span></p> <p><span style="font-size: 10pt;"><br />The group now finds that these two defects are linked. In mice with Alzheimer&rsquo;s disease-like disease, elevated acid sphingomyelinase activity clogged up the autophagy machinery resulting in the accumulation of undigested cellular waste. Reducing levels of acid sphingomyelinase restored autophagy, lessened brain pathology, and improved learning and memory in the mice. Provided these results hold true in humans, interfering with acid sphingomyelinase activity might prove to be an effective way to slow&mdash;and possibly reverse&mdash;neurodegeneration in patients with Alzheimer&rsquo;s disease.</span></p></div> Scientists find new clues to brain’s wiring 2014-07-21T15:40:00Z 2014-07-21T15:40:00Z <div id="ImageMain7" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction7" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>New research provides an intriguing glimpse into the processes that establish connections between nerve cells in the brain. These connections, or synapses, allow nerve cells to transmit and process information involved in thinking and moving the body.</strong></span></p> </div><div id="Text17" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Reporting online in&nbsp;<a href="" target="_blank"><em>Neuron</em></a>, researchers at Washington University School of Medicine in St Louis have identified a group of proteins that programme a common type of brain nerve cell to connect with another type of nerve cell in the brain.</span></p> <p><span style="font-size: 10pt;"><br />The finding is an important step forward in efforts to learn how the developing brain is built, an area of research essential to understanding the causes of intellectual disability and autism.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We now are looking at how loss of this wiring affects brain function in mice,&rdquo; says senior author Azad Bonni, the Edison Professor of Neurobiology and head of the Department of Anatomy and Neurobiology at the School of Medicine.</span></p> <p><span style="font-size: 10pt;"><br />Bonni and his colleagues are studying synapses in the cerebellum, a region of the brain that sits in the back of the head. The cerebellum plays a central role in controlling the coordination of movement and is essential for what researchers call procedural motor learning, which makes it possible to move our muscles at an unconscious level, such as when we ride a bicycle or play the piano.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The cerebellum also regulates mental functions,&rdquo; Bonni says. &ldquo;So, impairment of the wiring of nerve cells in the cerebellum may contribute to movement disorders as well as cognitive problems including autism spectrum disorders.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />His new results show that a complex of proteins known as NuRD (nucleosome remodelling and deacetylase) plays a fairly high supervisory role in some aspects of the cerebellum&rsquo;s construction. When the researchers blocked the NuRD complex, cells in the cerebellum called granule cells failed to form connections with other nerve cells, the Purkinje neurons. These circuits are important for the cerebellum&rsquo;s control of movement coordination and learning.</span></p> <p><span style="font-size: 10pt;"><br />Bonni and his colleagues showed that NuRD exerts influence at the epigenetic level, which means it controls factors other than DNA that affect gene activity. For example, NuRD affects the configurations of molecules that store DNA and that can open and close the coils of DNA like an accordion, making genes less or more accessible. Changing the accessibility of genes changes their activity levels. For instance, cells cannot frequently make proteins from genes in a tightly packed coil of DNA.</span></p> <p><span style="font-size: 10pt;"><br />NuRD also alters tags on the proteins that store DNA, decreasing the chances that the gene will be used. Among the genes deactivated by NuRD are two that control the activity of other genes involved in the wiring of the cerebellum.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This tells us that the NuRD complex is very influential&mdash;not only does it affect the activity of genes directly, it also controls other regulators of multiple genes,&rdquo; Bonni says.</span></p></div> Making a mental match: Pairing a mechanical device with stroke patients 2014-07-18T12:24:00Z 2014-07-18T12:24:00Z <div id="ImageMain8" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction8" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The repetitive facilitation exercise is one of the most common rehabilitation tactics for stroke patients attempting to regain wrist movement. Stroke hemiparesis individuals are not able to move that part of their body because they cannot create a strong enough neural signal that travels from the brain to the wrist.</strong></span></p> </div><div id="Text18" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">With repetitive facilitation exercise, however, patients get a mental boost. They are asked to think about moving. At the same time, a practitioner flexes the wrist. The goal is to send a long latency response from the stretch that arrives in the brain at the exact time the thought happens, creating a neural signal. The result is a strong, combined response that zips back to the forearm muscles and moves the wrist.</span></p> <p><span style="font-size: 10pt;">It all happens in a span of approximately 40 to 60 milliseconds.&nbsp;</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Timing is everything. When the window is that small, it is not easy for two people to match each other,&rdquo; says Georgia Institute of Technology master&rsquo;s graduate Lauren Lacey.</span></p> <p><br /><span style="font-size: 10pt;">That&rsquo;s why Lacey and a team of fellow Georgia Tech researchers created&nbsp;a mechanical device that takes people out of the process, replacing them with accurate computers. Their functional MRI-compatible hemiparesis rehab device creates a long latency stretch reflex at the exact time as a brain signal.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;It&rsquo;s kind of like trying to fill a bucket with water,&rdquo; explains Minoru Shinohara, an associate professor in Georgia Tech&rsquo;s Human Neuromuscular Physiology Lab. &ldquo;Stroke individuals can only mentally fill it halfway. The machine pours in the rest to make it full.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">So far, the research team has worked only with healthy individuals in their study. Study participants lie on a bed with the arm extended beneath a pneumatic actuator tendon hammer. In order to simulate the weak signal created by hemiparesis individuals to move their wrist, a transcranial magnetic stimulator (TMS) is placed on the heads of these healthy individuals at a 45-degree angle. Milliseconds after the hammer taps the wrist&rsquo;s tendon, the TMS creates a weak signal in the motor cortex. The responses overlap, produce and send a strong signal back to the arm, and the wrist moves.</span></p> <p><br /><span style="font-size: 10pt;">The team has successfully varied the timing of the transcranial magnetic stimulator signal and speed of the hammer to strike faster or slower depending on how much of a boost is needed to complement the brain signal. Now that the researchers have proven the viability of the transcranial magnetic stimulator-actuator system, they will next work with stroke individuals.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The device is designed to adapt to people whether they are hyper, normo or hyporeflexive,&rdquo; says Lacey, who graduated in spring with a master&rsquo;s degree from the George Woodruff School of Mechanical Engineering.</span></p> <p><br /><span style="font-size: 10pt;">Also, because the machine is MRI-compatible, it will allow the team to study what is happening in the brain during rehab, opening the door for robotics.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Once we fully understand what is happening mentally and physiologically, we should be able to create a robot that can reproduce successful rehabilitative exercises such as repetitive facilitation exercise,&rdquo; says Jun Ueda, an associate professor in the School of Mechanical Engineering. &ldquo;It appears that the timing is the critical piece of this exercise. Robots are great at timing, so the results are very promising for robotics.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Georgia Tech team was assisted by researchers at Japan&rsquo;s Kagoshima University, Kazumi Kawahira, Megumi Shimodozono and Yong Yu, who originally performed clinical studies of conventional repetitive facilitation exercise. The device was presented at the&nbsp;Design of Medical Devices Conference&nbsp;in Minneapolis, Minnesota, USA this spring.</span></p> <p><br /><span style="font-size: 10pt;">This research was partially supported by the National Science Foundation (NSF) under sub-award EEC 0540834. Any conclusions expressed are those of the principal investigator and may not necessarily represent the official views of the NSF.</span></p></div> JAMA study: Stroke risk and death rates fall over past two decades 2014-07-18T11:57:00Z 2014-07-18T11:57:00Z <div id="ImageMain9" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction9" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Fewer Americans are having strokes and those who do have a lower risk of dying from them finds a new study led by Johns Hopkins Bloomberg School of Public Health researchers.</strong></span></p> </div><div id="Text19" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study found a 24% overall decline in first-time strokes in each of the last two decades and a 20% overall drop per decade in deaths after stroke. However, the decline in stroke risk was concentrated mainly in the over-65 set, with little progress in reducing the risk of strokes among young people. In contrast, the drop in stroke-related deaths each decade was primarily found among those under age 65, with mortality rates holding firm in older people.</span><br /> <br /><span style="font-size: 10pt;"> A report on the results is published in the July 16 issue of the&nbsp;<a href="" target="_blank"><em>Journal of the American Medical Association</em>&nbsp;(<em>JAMA</em>)</a>.</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;We can congratulate ourselves that we are doing well, but stroke is still the number four cause of death in the United States,&rdquo; says study co-author Josef Coresh, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. &ldquo;This research points out the areas that need improvement. It also reminds us that there are many forces threatening to push stroke rates back up and if we do not address them head-on, our gains may be lost.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> Coresh says he worries what the future of stroke will look like as the obesity epidemic, which began in the 90s, matures. As millions more are diagnosed with hypertension and diabetes &ndash; which often go hand-in-hand with obesity -- they will face increased risk for stroke.</span><br /> <br /><span style="font-size: 10pt;"> For their analysis, researchers used results from the Atherosclerosis Risk in Communities (ARIC) study, a prospective study of 15,792 residents of four US communities who were between the ages of 45 and 64 when the study began in the late 1980s. In this analysis, they followed 14,357 participants who were free of stroke in 1987, looking specifically for all stroke hospitalisations and deaths between then and the end of 2011.</span><br /> <br /><span style="font-size: 10pt;"> Seven per cent of the study sample (1,051) had a stroke over that period. Of those, 10% died within 30 days, and 21%, 40% and 58% died within one year, five years and by the end of the study in 2011. Each decade, the number of deaths occurring within 10 years of a stroke was reduced by roughly eight deaths per 100 cases. The decrease was not across the board. Instead it was primarily the result of stroke victims under the age of 65 surviving longer. While they varied by age, the results were similar across race and gender, a finding that researchers were heartened to discover since a previous study suggested African-American stroke rates were not improving.</span><br /> <br /><span style="font-size: 10pt;"> The researchers found that the decrease in stroke incidence and mortality is partly due to more successful control of risk factors such as blood pressure, smoking cessation and the wide use of statin medications for controlling cholesterol. However, an increase in diabetes likely acted in the opposite direction, pushing up stroke rates, though to a lesser extent. Stroke severity and improvements in treatment likely also impacted the data, though the study could not measure the exact role they played.</span><br /> <br /><span style="font-size: 10pt;"> The age disparities in outcomes suggest areas where physicians and researchers may want to focus in the future to prevent strokes in those under 65 and reduce deaths in those over 65.</span><br /> <br /><span style="font-size: 10pt;"> Nearly 800,000 Americans suffer strokes each year; of those, about 600,000 are first-time strokes. &ldquo;Stroke is not only one of the main causes of death, but a leading cause of long-term disability in adults. Therefore, prevention is the best strategy,&rdquo; says study leader Silvia Koton, a visiting faculty member at the Bloomberg School and incoming nursing department chair at Tel Aviv University.</span><br /> <br /><span style="font-size: 10pt;"> National data show that the number of death certificates listing stroke as the underlying cause of death has decreased for a long time. However, only research studies such as this one can distinguish whether the decline is due to a reduction in the number of strokes or whether people are just living longer after having them, researchers say. In this study, researchers also confirmed the occurrence of each stroke by reviewing each medical chart using uniform criteria. Researchers focused on deaths from all causes because following a stroke, many patients die from other causes including heart disease and pneumonia.</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Since rates are not equally falling across the board, physicians and policymakers need to pay closer attention to specific subgroups,&rdquo; Koton says. &ldquo;These data are also helpful in monitoring the results of how we care for people of all ages, hopefully helping them even before they have a stroke.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> The ARIC study is supported by contracts with the National Institutes of Health&rsquo;s National Heart, Lung, and Blood Institute as well as NHLBI grants.</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Stroke Incidence and Mortality Trends in US Communities, 1987 to 2011,&rdquo; was written by Silvia Koton; Andrea L.C. Schneider; Wayne Rosamond; Eyal Shahar; Tingying Sang; Rebecca Gottesman; and Josef Coresh.</span></p></div> ROADSTER trial studying new path to carotid revascularisation completes patient enrolment 2014-07-18T11:02:00Z 2014-07-18T11:02:00Z <div id="ImageMain10" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction10" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Silk Road Medical has announced the completion of enrolment in its pivotal <a href=";rank=1" target="_blank"><span style="color: #000080;">ROADSTER</span></a> study. The trial was the first of its kind to study the treatment of carotid artery stenosis by placing a stent via direct access to the common carotid artery in the neck in an entirely new minimally invasive procedure. The device under study is the company&rsquo;s Enroute transcarotid neuroprotection system which incorporates proven surgical principles to protect the brain from a stroke during carotid angioplasty and stenting, and features a mechanism to divert dangerous debris away from the brain by temporarily reversing blood flow. Data from the trial will be used to support 510(k) clearance of the Enroute transcarotid neuroprotection system as well as pre-market approval of the Enroute transcarotid stent system.</strong></span></p> </div><div id="Text110" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Enroute transcarotid neuroprotection system was designed to reduce the excess stroke risk of a carotid stent procedure, while at the same time minimising the surgical risks of an open carotid artery surgery known as carotid endarterectomy,&rdquo; says Sumaira Macdonald an expert in the field of carotid artery disease and Silk Road Medical&rsquo;s chief medical officer. &ldquo;Until now, carotid stents were typically placed via the femoral artery approach, which is about three feet from the culprit carotid stenosis, and requires navigation of catheters and other instruments through often hostile territory, increasing the risk of stroke during or immediately after the procedure,&rdquo; she says. &ldquo;We know that carotid stents are effective in preventing strokes in the long term, but we need a safer way to deliver them. The Silk Road procedure moves the access point to within inches of the stenosis to avoid at-risk steps and provides a surgically-inspired method of protecting the brain throughout the simplified procedure.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">By contrast, the gold standard carotid endarterectomy procedure requires a large incision in the neck and a surgery that carries some risk of nerve damage, bleeding, scarring and infection. The Silk Road procedure is designed to reduce these surgical risks as well. &ldquo;Historically, there has not been a safe and effective minimally invasive procedure that could hold up to the clinical outcomes established by carotid endarterectomy. This new procedure may be it,&rdquo; says Richard Cambria, chief, Division of Vascular and Endovascular Surgery at Massachusetts General Hospital and The Robert R Linton MD Professor of Vascular and Endovascular Surgery at the Harvard Medical School. &ldquo;The results from our centre will be announced at the VEITH Symposium.&rdquo; Cambria serves as the National co-principal investigator for the ROADSTER trial.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The ROADSTER trial included an elite, multi-disciplinary group of physicians across the US and Europe with vast experience in treating carotid disease,&rdquo; says Christopher Kwolek, director of the Vascular and Endovascular training programme at Massachusetts General Hospital, chief of Vascular Surgery at Newton Wellesley Hospital, and National co-principal investigator for the ROADSTER trial. &ldquo;Similar to important endovascular innovations in aortic aneurysms and peripheral arterial disease, this new minimally invasive procedure will be an important step forward in the treatment of carotid artery disease for the vascular specialist.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Erica Rogers, chief executive officer for Silk Road Medical, comments, &ldquo;We believe the ROADSTER data will support clearance and approval of our planned marketing applications with the FDA. We are grateful for the collaboration of our investigators who allowed this study to complete enrolment on time. We are quite eager to present the full results of the study in the near future.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Both the Enroute transcarotid neuroprotection system and stent system have been granted CE mark approval. The Enroute transcarotid neuroprotection system is limited by United States law to investigational use. The Enroute transcarotid stent system is not currently available in the United States.</span></p></div> Stroke inpatient rehabilitation facilities yield better neurological outcomes than skilled nursing facilities 2014-07-17T09:38:00Z 2014-07-17T09:38:00Z <div id="ImageMain11" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction11" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A demographic analysis has revealed that an association exists between discharge disposition and National Institutes of Health Stroke Scores (NIHSS) at 90-day follow-up. Patients discharged to an inpatient rehabilitation facility were found to have more favourable outcomes compared with those sent home or to a skilled nursing facility. According to the authors, this study is the first to examine the role of discharge disposition in an acute stroke treatment trial in the modern era.</strong></span></p> </div><div id="Text111" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Rishi Gupta (Wellstar Neurosurgery, Marietta, USA) and others evaluated the demographic data from the SENTIS (The safety and efficacy of NeuroFlo technology in ischemic stroke) trial to determine the impact of stroke severity and discharge disposition on 90-day outcomes in US patients&mdash;the results were published in the <a href="" target="_blank"><em>Journal of NeuroInterventional Surgery</em></a>.</span></p> <p><br /><span style="font-size: 10pt;">The <a href=";rank=1" target="_blank"><strong>SENTIS</strong></a> trial, originally published in the <a href="" target="_blank"><em>American Journal of Neuroradiology</em></a> in 2013, was a multicentre, prospective, randomised controlled trial that evaluated the safety and effectiveness of the NeuroFlo catheter (CoAxia) in stroke patients compared to standard medical therapy. In the trial, it was found that there were consistent reductions in all-cause and stroke-related mortality in the NeuroFlo-treated patients. Although the results showed that treatment with NeuroFlo was safe, it was also demonstrated that there was not a benefit of doing so when compared to standard medical therapy. Therefore, Gupta and colleagues analysed NIHSS from days one and four, discharge disposition and 90-day modified Rankin Score to investigate whether discharge disposition to home or acute rehabilitation is associated with a clinical favourable outcome from the SENTIS data.</span></p> <p><br /><span style="font-size: 10pt;">Of the 292 patients, 153 (52.1%) were discharged to an inpatient rehabilitation facility, 11 (38%) to home and 28 (9.6%) to a skilled nursing facility.</span></p> <p><br /><span style="font-size: 10pt;">Two out of the 28 patients discharged to a skilled nursing facility achieved a 90-day modified Rankin Score of &le;2 compared with the 60/153 patients in the inpatients rehabilitation facility (OR 8.39, 95% CI 1.92 to 36.64, p=0.0047).&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to Gupta <em>et al,</em> these results show that an association between outcomes and discharge disposition remains after adjustments for age and admission NIHSS.</span></p> <p><br /><span style="font-size: 10pt;">They add that three of the 50 patients with NIHSS of &ge;14 at four days achieved modified Rankin Scored of 0&ndash;2 at 90 days.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This analysis shows that discharge to an inpatient rehabilitation facility is associated with better neurological outcomes than discharge to a skilled nursing facility. Additionally, patients with NHISS of &ge;14 at day four are unlikely to achieve independent function.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Co-author Samir R Belagaje, assistant professor, Neurology and Rehabilitation Medicine, Emory University School of Medicine, USA, spoke to <em>NeuroNews</em> and shed light on the implications of the findings of the study for the future.</span></p> <p><span style="font-size: 10pt;"><strong><br />How could these findings be applied to patient care after stroke in the future?</strong></span></p> <p><br /><span style="font-size: 10pt;">Our results reinforce the concept that care of patients with stroke must be optimised in all phases of their care and not just the acute phase. In the real world, neurologists and other healthcare practitioners should try to get their patients to their acute rehabilitation (inpatient rehabilitation) whenever possible and when their patients are unable to go home immediately. In the research world, our research helps with the design of future clinical trials of acute stroke intervention by pointing out the importance of the discharge disposition and possibly standardised. Our data may also point to further examination of the decision process in determining which patients go to inpatient rehabilitation facility vs. skilled nursing facility and help get more patients to an inpatient rehabilitation facility to improve their overall outcome.</span></p> <p><span style="font-size: 10pt;"><strong><br />Would discharging all patients to an inpatient rehabilitation facility be cost-effective?</strong></span></p> <p><br /><span style="font-size: 10pt;">We do not have any data at this point to clearly say one way or another. It is probably not cost-effective as there are some patients who, because of their stroke severity, simply do not make the improvements to justify the resources in terms of therapists and the intensity of therapy. They would do the same with less intensity as provided in a skilled nursing facility.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Furthermore, there are some patients because of their age, stroke severity, or other medical comorbidities are unable to tolerate the intensity of the inpatient facility rehabilitation and could actually do worse. This would result in more acute hospitalisations, longer stays in facilities, and worsened outcomes all of which would add further costs making this strategy less cost-effective.</span></p></div> Banner Alzheimer&apos;s Institute partners with Novartis in new study of Alzheimer&apos;s prevention treatments 2014-07-16T15:19:00Z 2014-07-16T15:19:00Z <div id="Introduction12" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers from the Banner Alzheimer&rsquo;s Institute (BAI) have announced a partnership with Novartis in a pioneering medical trial to determine whether two investigational anti-amyloid drugs&mdash;an active immunotherapy and an oral medication&mdash;can prevent or delay the emergence of symptoms of Alzheimer&rsquo;s in people at particularly high risk for developing the disease at older ages.</strong></span></p> </div><div id="Text112" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The five-year APOE4 trial will involve more than 1,300 cognitively healthy older adults, ages 60&nbsp;to 75<em>,&nbsp;</em>at high risk of developing symptoms of&nbsp;Alzheimer&rsquo;s because they inherited two copies of the apolipoprotein E (APOE4) gene&mdash;one from each parent. About 2% of the world&rsquo;s population carries two copies of this gene and one in four people carry one copy of the APOE4 gene, which is strongly linked to late-onset Alzheimer&rsquo;s.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We are taking clinical trials to a critical new stage,&rdquo; says Pierre N Tariot, study director for BAI, an arm of Banner Health, one of the largest non-profit healthcare systems in&nbsp;the United States. &ldquo;This approach shifts the research paradigm from trying to reverse disease damage to attacking and preventing its cause, years before symptoms could surface.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The trial&mdash;subject to regulatory authority approval&mdash;will begin in 2015 at approximately 60 sites in&nbsp;Europe&nbsp;and North America, including BAI&rsquo;s headquarters in&nbsp;Phoenix, Arizona, USA.</span></p> <p><br /><span style="font-size: 10pt;">The active immunotherapy is aimed at triggering the body&rsquo;s immune system to produce antibodies that attack different forms of the amyloid protein, which many researchers have suggested plays a critical role in the development of Alzheimer&rsquo;s. The oral medication is a BACE (beta-secretase1) inhibitor, designed to prevent the production of different forms of the amyloid protein.</span></p> <p><br /><span style="font-size: 10pt;">The two drugs, which will be tested separately, are intended to stop the accumulation of amyloid. The drugs are being introduced even before amyloid accumulates in some of the participants&rsquo; brains. The trial will increase the chance of finding treatments that will prevent, slow or delay the loss of memory and other cognitive abilities associated with Alzheimer&rsquo;s.</span></p> <p><br /><span style="font-size: 10pt;">Study participants will be recruited via multiple venues, including the Alzheimer&rsquo;s Prevention Registry website created by BAI in 2012. The registry currently has more than 37,000 potential volunteers and is aiming to recruit more than 250,000.</span></p> <p><br /><span style="font-size: 10pt;">Volunteers who meet the study criteria will be asked to mail a sample of their genetic material (such as a cheek swab) to a laboratory. The volunteers will learn the results of that test in the context of possibly enrolling in the trial.</span></p> <p><br /><span style="font-size: 10pt;">Volunteers who are selected for the API APOE4 study will receive genetic counselling. &ldquo;We are keenly aware of the extreme sensitivity and emotional impact of disclosing genetic information,&rdquo; Langbaum says.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;There are no guarantees that any of these investigational treatments will prevent the clinical onset of Alzheimer&rsquo;s disease,&rdquo; says Eric M Reiman, one of the study directors for BAI. &ldquo;But we are grateful for these opportunities to find out.&rdquo;</span></p></div> Worldwide Alzheimer&apos;s and dementia epidemic grows 2014-07-15T15:41:00Z 2014-07-15T15:41:00Z <div id="ImageMain13" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction13" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>While the global epidemic of Alzheimer&rsquo;s disease continues to grow, new data on lower incidence in the &ldquo;youngest old&rdquo; from developed countries in Europe&nbsp;and&nbsp;the United States&nbsp;suggest the possibility of reducing risk and/or preventing the disease, according to the results of several research studies announced at the Alzheimer&rsquo;s Association International Conference2014 (AAIC&nbsp;2014) in&nbsp;Copenhagen, Denmark. Scientists suggest higher education levels and more aggressive treatment of cardiovascular disease may be key.</strong></span></p> </div><div id="Text113" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Pointing in the other direction, researchers reported at AAIC 2014 that incidence and prevalence of Alzheimer&rsquo;s in developing countries such as&nbsp;Colombia, and large regions of&nbsp;Asia&nbsp;and&nbsp;Africa, may be severely underreported. They also raise questions about the effects of the growing incidence of obesity and diabetes in developed countries, both of which are associated with increased risk of cognitive decline and dementia.</span></p> <p><span style="font-size: 10pt;">For clarity following are the definitions of prevalence and incidence:</span></p> <ul> <li><span style="font-size: 10pt;">Prevalence &ndash; the number or proportion of cases of a disease in a population. (ie., How many people have Alzheimer&rsquo;s disease in the USA right now?)</span></li> <li><span style="font-size: 10pt;">Incidence &ndash; the number of new cases of a disease in a population over a given time. (ie., How many new cases of Alzheimer&rsquo;s are there this year in&nbsp;Denmark?)</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;The good news is that recent trends in developed countries in&nbsp;Europe&nbsp;and the USA suggest that reduction and possibly even prevention of Alzheimer&rsquo;s disease might be possible &ndash; but, at the same time, we must acknowledge the growing worldwide epidemic,&rdquo; says&nbsp;Maria Carrillo, Alzheimer&rsquo;s Association vice president of Medical and Scientific Relations. &ldquo;We must continue efforts to halt this terrible scourge that devastates families and economies.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;According to new data reported at AAIC 2014, Alzheimer&rsquo;s and dementia incidence and prevalence in developing countries may be much higher than previously thought, and rising rates of obesity and diabetes pose an unknown but potentially serious threat to cognitive health throughout the world. Many questions remain, and the only way we can get the answers is through more research,&rdquo; Carrillo says.</span></p> <p><br /><span style="font-size: 10pt;">There are hints in the literature that engaging in more challenging mental activities, such as higher levels of education or intellectually demanding occupations, may increase cognitive reserve and thereby reduce the risk of developing Alzheimer&rsquo;s or another dementia.</span></p> <p><span style="font-size: 10pt;"><strong><br />Review of recent data suggests fewer new cases of Alzheimer&rsquo;s in&nbsp;the United States&nbsp;and&nbsp;Europe<br /> <br /> </strong>Worldwide prevalence of Alzheimer&rsquo;s disease is projected to increase in the decades ahead as the planet&rsquo;s population ages, but recently published studies from&nbsp;the United States,&nbsp;the Netherlands,&nbsp;Sweden, and&nbsp;England suggest a decline in incidence or prevalence of dementia (or both) in those countries, according to a review of recent research conducted by&nbsp;Kenneth Langa of the&nbsp;University of Michigan&nbsp;and the VA Ann Arbor Center for Clinical Management Research, and reported at a plenary session at AAIC 2014.</span></p> <p><span style="font-size: 10pt;"><br />Langa observed from the studies that a number of factors, especially rising levels of education and more aggressive treatment of cardiovascular risk factors such as hypertension and high cholesterol, may be leading to improved brain health and consequent decline of numbers of new cases of Alzheimer&rsquo;s disease and dementia in certain countries or regions of the world.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Whether this trend will continue in the face of rising levels of obesity and diabetes, and whether it is also true in low- and middle-income countries, are key unanswered questions,&rdquo; says Langa. &ldquo;The answers will have enormous implications for the extent of the future worldwide impact of Alzheimer&rsquo;s disease and dementia in the decades ahead.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Extent of dementia in&nbsp;Asia&nbsp;and Sub-Saharan Africa may be severely underestimated<br /> <br /> </strong>In 2009, Alzheimer&rsquo;s Disease International (ADI) published data on global prevalence of dementia based on a review of 154 worldwide studies and United Nations (UN) population projections. Alzheimer&rsquo;s Disease International carried out an update on that data for the&nbsp;December 2013&nbsp;G8 Dementia Summit in&nbsp;London, focusing primarily on new evidence from&nbsp;Asia and Sub-Saharan Africa, and presented the results at AAIC 2014.</span></p> <p><span style="font-size: 10pt;"><br />Based on a meta-analysis of Chinese and Sub-Saharan African studies combined with the latest UN population projections, Alzheimer&rsquo;s Disease International concluded that the 2009 estimates of worldwide Alzheimer&rsquo;s disease were too low. Alzheimer&rsquo;s Disease International now estimates that 44.35 million people in the world were living with dementia in 2013, significantly up from the earlier estimate of 36 million people living with dementia in 2010. They project that the number will rise to 75.62 million in 2030 &mdash; 15% higher than the 2009 estimate &mdash; and 135.46 million in 2050, which is 17% higher than the 2009 Alzheimer&rsquo;s Disease International estimate.</span></p> <p><br /><span style="font-size: 10pt;">Specifically in the two focus regions, the researchers found that dementia prevalence increased for&nbsp;East Asia from about 5% to about 7%, and in Sub-Saharan African regions from a range of roughly 2 to 4% to 4.76%.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Dementia, including Alzheimer&rsquo;s disease, is one of the biggest global health challenges facing our generation,&rdquo; says&nbsp;Marc Wortmann, executive director, Alzheimer&rsquo;s Disease International. &ldquo;As more and better data becomes available, the effect we&rsquo;ve seen is a reduction in the variation of prevalence between world regions.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In addition, newly available data suggests that the current burden and future impact of the global dementia epidemic has been underestimated, particularly for the&nbsp;Asia&nbsp;and Sub-Saharan Africa. Especially in light of these revised estimates, there is an urgent need to develop policies to face this disease in all countries of the world, and to enhance our efforts in finding a cure or treatment that can delay the onset of dementia,&rdquo; Wortmann adds.</span></p> <p><span style="font-size: 10pt;"><strong><br />New sases of dementia decline over three decades in the Framingham Heart Study<br /> <br /> </strong>At AAIC 2014,&nbsp;Claudia L Satizabal of&nbsp;Boston University School of Medicine&nbsp;and colleagues reported on the results of a study of dementia trends among participants in the Framingham Heart Study, an ongoing, long-term (since 1948), multi-generational cardiovascular health study of residents of&nbsp;Framingham, Massachusetts, USA, to which dementia tracking has been added since 1975.</span></p> <p><span style="font-size: 10pt;"><br />Framingham Study participants undergo comprehensive assessments for cardiovascular risk factors every two to four years, and remain under intensive surveillance for dementia and stroke. Study researchers defined four non-overlapping five-year time windows (epochs) across the past three decades, each beginning with a baseline examination, and studied new cases of dementia among all dementia-free participants age 60 and older.</span></p> <p><br /><span style="font-size: 10pt;">After adjusting for age at entry and gender, the researchers found that compared with the first epoch, the second epoch had a 22% reduction in new cases of dementia, the third had a 38% reduction, and the fourth had a 44% reduction. The reduction was strongest in participants between age 60 and 69.</span></p> <p><br /><span style="font-size: 10pt;">The researchers found the decrease in dementia incidence was greatest in women across all epochs, while men showed a more gradual decrease over time. The decreasing trend in dementia incidence was true for individuals with a higher educational level, defined as having a high school diploma, whereas individuals without a high school diploma did not appear to benefit from this reduction.</span></p> <p><br /><span style="font-size: 10pt;">During that 30-year time period, the researchers observed among the participants a substantial improvement in educational achievement, better management of blood pressure, higher levels of HDL cholesterol, and a considerable decline in smoking, heart disease and stroke across the same epochs. However, an increasing trend in obesity and diabetes was seen in this population.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These reductions in age-specific rates of new cases of dementia in the Framingham Study participants might be partly explained by the beneficial trends we observed in educational attainment and heart health risk factors,&rdquo; says Satizabal. &ldquo;This leads us to cautious optimism that some cases of dementia may be preventable. However, one of the limitations of this work is that the&nbsp;Framingham&nbsp;sample is largely of European descent. Additional studies are needed in populations of different racial and ethnic backgrounds.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />In&nbsp;Colombia, dementia and Alzheimer&rsquo;s disease might be underestimated by up to 50%<br /> <br /> </strong>To date,&nbsp;Colombia&nbsp;has had only one study, known as EPINEURO, which attempted to estimate the country&rsquo;s dementia prevalence from representative samples of the population 20 years ago. Using updated population estimates and prevalence estimates published in the international literature,&nbsp;Yuri Takeuchi of Universidad Icesi (Colombia) and colleagues estimated the number of people with dementia, and especially Alzheimer&rsquo;s disease, in&nbsp;Colombia&nbsp;by stage of the disease. The results were reported at AAIC 2014.</span></p> <p><br /><span style="font-size: 10pt;">The researchers created three models for Alzheimer&rsquo;s prevalence in the country, each using different projections for the proportion of people with mild, moderate, and severe disease, and different theoretical assumptions on the transitions between stages. They found that the number of people with Alzheimer&rsquo;s in Colombia&nbsp;could be as much as 220,000 in 2015, and 260,000 in 2020. The scientists calculate that current estimates for Alzheimer&rsquo;s disease and other dementias in&nbsp;Colombia&nbsp;might be too low by as much as 50%. (The prevalence estimate of dementia for&nbsp;Colombia&nbsp;in people over 65 used in the study was 6%, according to Takeuchi.)</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;To our knowledge, this is the first attempt to model and estimate dementia prevalence by stage of disease in the developing world; it is certainly the first attempt in&nbsp;Colombia,&rdquo; says Takeuchi. &ldquo;The fastest growth in ageing is happening in developing countries such as&nbsp;Colombia. This has profound implications not only for older people themselves, but for their households, social and community infrastructure, and social policy. These estimations by stage of disease are key information for policymakers because both the social burden and social costs are substantially different depending on the stage of disease.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Dementia in&nbsp;Germany&nbsp;declined between 2007 and 2009<br /> <br /> </strong>Gabriele Doblhammer of the German Center for Neurodegenerative Diseases (DZNE) and colleagues conducted a study exploring short-term dementia trends in&nbsp;Germany, and reported the results at AAIC 2014.</span></p> <p><br /><span style="font-size: 10pt;">The research is based on claims data from the largest public health insurance company in&nbsp;Germany&nbsp;which covers about one-third of the total population aged 50+ and more than half of the oldest-old. The data include complete records of the inpatient and outpatient services, including dementia diagnosis. The complete insured population of roughly five million people at risk of dementia and about 600,000 dementia cases was used to study the prevalence; a 2.5% sample was the basis for the incidence study.</span></p> <p><br /><span style="font-size: 10pt;">The researchers found that between 2007 and 2009, the total number of people with dementia decreased significantly among German women age 74 to 85. Dementia prevalence in 2009 was 3.6% lower than in 2007 and 1.8% lower than in 2008. Over that period, new cases of dementia decreased significantly for both men and women.</span></p> <p><br /><span style="font-size: 10pt;">According to the researchers, over the last decade there was reduction in new cases of cerebrovascular disease in&nbsp;Germany&nbsp;and a &ldquo;better treatment of vascular risk factors such as high blood pressure, hypercholesterolemia, and diabetes mellitus.&rdquo; Among the elderly, increasing levels of education and wealth also were observed.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This was the first study to explore dementia trends in&nbsp;Germany,&rdquo; says Doblhammer. &ldquo;The ageing of the babyboomers and the increasing life expectancy will lead to more dementia cases in old age. It is necessary to explore the modifiable risk factors of dementia in order to prevent the occurrence of the disease. In addition, more research is needed whether the increasing obesity epidemic and related diseases, such as the metabolic syndrome, may counterbalance the positive trends we are observing today,&rdquo; the researchers add.</span></p></div> C2N expands partnership with Washington University School of Medicine 2014-07-15T15:11:00Z 2014-07-15T15:11:00Z <div id="ImageMain14" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction14" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>C<sub>2</sub>N Diagnostics has announced that it has expanded its partnership with Washington University School of Medicine (WUSM) in St Louis, USA. The objective of this collaboration is to commercialise a clinical blood test for detecting the earliest stages of Alzheimer&rsquo;s disease as well as mild cognitive impairment. Under terms of the agreement, C<sub>2</sub>N has acquired the exclusive worldwide commercial license rights to a suite of technologies developed in the laboratories of professors Randall Bateman and David Holtzman in the Department of Neurology at WUSM.</strong></span></p> </div><div id="Text114" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The licensed technologies build upon the Stable Isotope Labelling Kinetics (SILK) platform pioneered at WUSM and already marketed by C<sub>2</sub>N. The new technologies enable a novel approach to measure the metabolism of brain-derived proteins implicated in Alzheimer&rsquo;s disease and mild cognitive impairment. For the first time, instead of analysing Alzheimer&rsquo;s disease proteins in cerebrospinal fluid, it is now possible to detect the same metabolic markers in patients&rsquo; blood samples.</span></p> <p><br /><span style="font-size: 10pt;">This capability has implications for the advancement of new treatments, early prevention, and personal wellness. Alzheimer&rsquo;s is now one of the major global healthcare concerns. Approximately 44 million people currently have clinical Alzheimer&rsquo;s disease. Millions more have mild cognitive impairment that places them at high risk for progression to clinical Alzheimer&rsquo;s disease. The number of cases of Alzheimer&rsquo;s disease and mild cognitive impairment are expected to increase sharply in the years ahead due to the aging baby boomer population.</span></p> <p><br /><span style="font-size: 10pt;">Pharmaceutical companies developing new drugs targeting Alzheimer&rsquo;s disease increasingly recognise that early intervention provides the greatest chance of halting or reversing disease progression. Biomarkers are needed to detect this early pathology, which can begin at least 15 years before the onset of any clinical symptoms. At the same time, dynamic biomarkers, like those offered by the SILK platform, may also track treatment responses during the pre-symptomatic stages of disease.</span></p> <p><br /><span style="font-size: 10pt;">Since 2008, C<sub>2</sub>N has applied the SILK-A&beta;&nbsp;test to measure the kinetics of beta-amyloid in cerebrospinal fluid. The test has served as a primary endpoint in clinical drug studies to demonstrate target engagement and guide dose selection. The SILK-A&beta;&nbsp;isoforms test is also highly sensitive to identifying people with brain amyloidosis (one of the earliest indicators of Alzheimer&rsquo;s disease), even before amyloid deposits are seen with brain imaging. Still, the more invasive nature of cerebrospinal fluid sampling has impeded the full potential of the SILK-A&beta;&nbsp;method.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;With a simplified SILK-A&beta;&nbsp;test available through blood sampling, we now have an opportunity to validate a unique therapeutic and diagnostic marker,&rdquo; states Joel B Braunstein, chief executive officer of C<sub>2</sub>N. &ldquo;We plan to achieve this validation by collaborating with pharmaceutical companies that are testing their compounds in phase 2 and phase 3 clinical studies, as well as by participating in natural history studies tracking the progression of Alzheimer&rsquo;s disease. If successful, we expect to be able to offer a reliable and informative screening test that is also convenient for patients.&rdquo;</span></p></div> St Jude Medical announces definitive agreement to acquire NeuroTherm 2014-07-14T16:48:00Z 2014-07-14T16:48:00Z <div id="Introduction15" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>St Jude Medical has announced that it has signed a definitive agreement to acquire privately held&nbsp;NeuroTherm, a manufacturer of interventional pain management therapies, for approximately&nbsp;US$200 million&nbsp;in cash.</strong></span></p> </div><div id="Text115" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">NeuroTherm is a global leader in the treatment of spinal pain using radiofrequency ablation (RFA), a segment of the chronic pain market in which&nbsp;St Jude Medical does not currently participate. The company expects to complete this transaction by the end of the third quarter, subject to customary closing conditions. NeuroTherm is expected to add approximately&nbsp;US$10 million to US$15 million&nbsp;to St Jude Medical&rsquo;s 2014 sales. Excluding acquisition-related expenses, this transaction will be neutral to St Jude Medical&rsquo;s consolidated earnings per share in 2014 and accretive thereafter on a GAAP basis.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;NeuroTherm&rsquo;s radiofrequency ablation products are an ideal complement to St Jude Medical&rsquo;s chronic pain portfolio, providing our global sales force with additional interventional pain therapies that offer potential relief to patients earlier in the chronic pain continuum,&rdquo; says&nbsp;Michael T Rousseau, chief operating officer of&nbsp;St Jude Medical. &ldquo;As the only medical device manufacturer with both RFA and spinal cord stimulation, this acquisition will enable us to offer more treatment options to patients worldwide who suffer from the debilitating effects of chronic pain.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />NeuroTherm&rsquo;s flagship technology is a multi-lesion radiofrequency generator that allows real-time temperature monitoring and enables continuous delivery of energy to each site designed to ensure complete treatment of each targeted spinal nerve. The company&rsquo;s products are available in over 65 countries.</span></p> <p><br /><span style="font-size: 10pt;">Christopher R von Jako, president and chief executive officer of NeuroTherm says, &ldquo;St Jude Medical&rsquo;s global leadership in chronic pain represents an excellent opportunity to bring NeuroTherm&rsquo;s radiofrequency ablation technologies to more pain specialists and patients. We are proud of the business that NeuroTherm has built and thank our employees and shareholders for their commitment to developing innovative interventional pain management therapies. We see a promising future with&nbsp;St Jude Medical&nbsp;that combines our products with a leading pain franchise and further develops the underpenetrated global market for chronic pain.&rdquo;</span></p></div> Looking back on 40 years of the Glasgow Coma Scale 2014-07-14T15:58:00Z 2014-07-14T15:58:00Z <div id="ImageMain16" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction16" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A group of leading brain injury specialists look back on 40 years of the Glasgow Coma Scale and outline the continuing role of the scale in research and clinical practice, in a new <a href="" target="_blank">Personal View</a> published in <em><a href="" target="_blank">The Lancet Neurology</a>.</em>&nbsp;&nbsp;&nbsp;</strong></span></p> </div><div id="Text116" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Personal View is published on the 40<sup>th</sup> anniversary of the Glasgow Coma Scale&rsquo;s introduction in a 1974 <em>Lancet</em> article.&nbsp;Since this seminal publication, the Glasgow Coma Scale has provided a practical method for bedside assessment of impairment of conscious level, the clinical hallmark of acute brain injury. The scale was designed to be easy to use in clinical practice in general and specialist units and to replace previous ill-defined and inconsistent methods. Forty years later, the Glasgow Coma Scale has become an integral part of clinical practice and research worldwide.</span></p> <p><br /><span style="font-size: 10pt;">The paper&rsquo;s lead author is Professor Graham Teasdale, of the University of Glasgow, UK, one of the authors of the original paper introducing the scale.&nbsp;Teasdale and colleagues examine the extent to which the original aspirations of the authors have been fulfilled, address some myths and misapprehensions about the scale, examine criticisms, and outline the continuing role of the scale in research and clinical practice.</span></p> <p><span style="font-size: 10pt;">A <em>Lancet Neurology </em>podcast interview with Professor Teasdale is available <a href="" target="_blank"><span style="color: #800000;"><strong>here</strong></span></a>.</span></p></div> Potential Alzheimer&apos;s disease risk factors and risk reduction strategies become clearer 2014-07-14T10:48:00Z 2014-07-14T10:48:00Z <div id="Introduction17" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Participation in activities that promote mental activity, and moderate physical activity in middle age, may help protect against the development of Alzheimer&rsquo;s disease and dementia in later life, according to new research reported at the Alzheimer&rsquo;s Association International Conference&nbsp;2014 (AAIC&nbsp;2014) in&nbsp;Copenhagen, Denmark.</strong></span></p> </div><div id="Text117" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Research reported at AAIC 2014 also showed that sleep problems &ndash; especially when combined with post-traumatic stress disorder (PTSD) &ndash; may increase dementia risk in veterans. Additionally, in a population of people age 90 and older, high blood pressure was seen to help protect against cognitive decline. This is counter intuitive as heart health risk factors, including hypertension, are generally considered to elevate risk of Alzheimer&rsquo;s and other dementias.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Determining more specifically the factors that raise and lower risk of Alzheimer&rsquo;s disease and other dementias is an essential component in our battle against the Alzheimer&rsquo;s epidemic,&rdquo; says&nbsp;Heather Snyder, Alzheimer&rsquo;s Association director of Medical and Scientific Operations. &ldquo;We are now getting a more clear idea of the opportunities for risk reduction through behaviour changes and other health factors. We are learning that Alzheimer&rsquo;s risk and protective factors may change over the course of our lives.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These studies from AAIC 2014 underscore the need to fund larger, longer-term studies in different and diverse populations to enable us to develop helpful &rsquo;prescriptions&rsquo; for lifestyle change &ndash; for example, which foods to eat and avoid, how much physical activity and what types &ndash; and to learn more specifically about how Alzheimer&rsquo;s and dementia risk factors change as we age,&rdquo; Snyder adds.</span><br /><br /></p> <p><span style="font-size: 10pt;"><strong>Cognitively stimulating activities are associated with greater brain volumes and higher cognitive test scores</strong></span></p> <p><br /><span style="font-size: 10pt;">Prior studies have suggested that participation in activities that stimulate thought, new ideas, new memories, and that challenge us mentally may encourage brain health as we age and possibly reduce risk of cognitive impairment and dementia. The mechanisms underlying this possible effect are not currently well understood.</span></p> <p><br /><span style="font-size: 10pt;">At AAIC 2014,&nbsp;Stephanie Schultz, and colleagues at the Wisconsin Alzheimer&rsquo;s Institute and the Wisconsin Alzheimer&rsquo;s Disease Research Center reported on the results of a study of 329 cognitively normal middle-aged adults (mean age=60.3 years, 69% women) enrolled in the Wisconsin Registry for Alzheimer&rsquo;s Prevention. Forty per cent of the participants were positive for the APOe4 gene and 74% had a parental family history of Alzheimer&rsquo;s, both of which are known to increase the risk for developing Alzheimer&rsquo;s.</span></p> <p><br /><span style="font-size: 10pt;">These at-risk adults reported their current engagement in cognitively-stimulating activities using the Cognitive Activity Scale (CAS), underwent MRI brain imaging, and completed a comprehensive battery of neurocognitive tests. The CAS consists of 10 items that ask individuals how often they participate in various cognitive activities, such as reading books and going to museums. The scientists focused on CAS-Games, which is a single item on the scale that asks participants how often they play games such as cards, checkers, crosswords or other puzzles.</span></p> <p><br /><span style="font-size: 10pt;">After controlling for factors known to influence brain volume and cognitive test scores, such as age and gender, the researchers found that a higher self-reported frequency of game playing was significantly associated with greater brain volume in several regions involved in Alzheimer&rsquo;s disease (such as the hippocampus) and with higher cognitive test scores on memory and executive function.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Our findings suggest that, for some individuals, engagement in cognitively stimulating activities, especially those involving games such as puzzles and cards, might be a useful approach for preserving brain structures and cognitive functions that are vulnerable to Alzheimer&rsquo;s disease,&rdquo; says Schultz. &ldquo;More detailed studies of specific cognitive activities, including games, would help further our understanding of how an active, healthy lifestyle may help delay the development of Alzheimer&rsquo;s.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Moderate exercise in middle age is associated with decreased risk of dementia</strong></span></p> <p><br /><span style="font-size: 10pt;">Of the growing body of research concerning lifestyle and brain health, and also the possibility of reduced risk of Alzheimer&rsquo;s and other dementias, perhaps the strongest and most consistent evidence exists for regular physical activity.</span></p> <p><br /><span style="font-size: 10pt;">Yonas E Geda, and colleagues at the Mayo Clinic investigated the relationship between timing of exercise (mid-life/50-65 vs late-life/70 and above) and risk of new cases of dementia in 280 older adults (median age=81) with mild cognitive impairment from the Mayo Clinic Study of Aging, and reported on their findings at AAIC 2014.</span></p> <p><br /><span style="font-size: 10pt;">A person with mild cognitive impairment has a slight but noticeable and measurable decline in cognitive abilities, including memory and thinking skills. These changes are serious enough to be noticed by the individuals experiencing them or to other people, but they are not severe enough to interfere with daily life or independent function. People with mild cognitive impairment are at an increased risk of developing Alzheimer&rsquo;s disease.</span></p> <p><br /><span style="font-size: 10pt;">Study participants completed a questionnaire on the frequency and intensity of exercise during their lifetime. After following the participants for about three years, the researchers found that a history of moderate physical exercise in middle age was associated with a significantly decreased risk of mild cognitive impairment progressing to dementia. (The association did not hold for either light or vigorous exercise in middle age, or for any level of physical activity in late life.)</span></p> <p><br /><span style="font-size: 10pt;">In a second study reported at AAIC, the researchers looked at the timing of physical exercise and the risk of new cases of mild cognitive impairment. The study participants were 1,830 older adults with normal cognition from the Mayo Clinic Study of Aging. Participants underwent neurological evaluations, cognitive tests, and a self-reported questionnaire about physical exercise habits in mid-life and late-life, and were followed for an average of 3.2 years. The scientists observed that light physical exercise in mid-life and late-life were associated with decreased risk of incident mild cognitive impairment. Additionally, vigorous mid-life as well as moderate late-life physical exercise were associated with decreased risk of incident mild cognitive impairment.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In our studies, we found that physical exercise at various levels, especially in mid-life, is beneficial for cognitive function,&rdquo; Geda says. &ldquo;These are intriguing results, but they are not yet conclusive. More research is needed to determine the extent and nature of physical activity in protecting against MCI and dementia.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Poor sleep is associated with higher dementia risk in veterans; PTSD more than doubles that risk</strong></span></p> <p><br /><span style="font-size: 10pt;">It is known that sleep disturbance is a risk factor for cognitive decline and dementia, but this association has not been carefully investigated in older veterans. At AAIC 2014,&nbsp;Kristine Yaffe of the&nbsp;University of California, San Francisco&nbsp;and colleagues reported on the results of a retrospective study of sleep disturbance and dementia among 200,000 veterans age 55 and older, 96.5% of whom were male.</span></p> <p><br /><span style="font-size: 10pt;">The researchers examined eight years of the veterans&rsquo; medical records. After controlling for variables such as gender, income, education, and health status, they found that veterans who had a diagnosis of non-specific sleep disturbance, apnoea, or insomnia at baseline had a 30% increased risk of dementia compared with veterans with no diagnosed sleep problems. They also found that veterans with both PTSD and sleep disturbance had an 80% increased risk of dementia.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This is the first investigation into the link between sleep disturbance and dementia in a large cohort of older, mostly male veterans,&rdquo; says Yaffe. &ldquo;Further research is needed to clarify the role of sleep disturbance as either a risk factor for, or an early symptom of, dementia among veterans, and in other populations as well.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />In people 90 and older, late onset hypertension may protect against dementia</strong></span></p> <p><br /><span style="font-size: 10pt;">While hypertension during midlife is considered to increase risk for Alzheimer&rsquo;s and other dementia, there is emerging research evidence suggesting that its role in dementia risk may change over time, and may instead help protect against dementia in people age 90 and over, known as the &ldquo;oldest old.&rdquo;&nbsp;Maria Corrada of the&nbsp;University of California, Irvine&nbsp;and colleagues investigated the relationship between risk of dementia, age of the onset of hypertension, and blood pressure measurements in the oldest old, and reported the results at AAIC 2014.</span></p> <p><br /><span style="font-size: 10pt;">The researchers followed 625 participants every six months for up to ten years in The 90+ Study, an ongoing longitudinal study of people age 90 and older. At enrolment, participants did not have dementia and were 93 years old on average; 69% were female. The researchers found that participants with a hypertension onset age of 80 to 89 years had a significantly lower risk of developing dementia compared with participants with no history of hypertension. Participants with onset at age 90 or older had an even lower dementia risk.</span></p> <p><br /><span style="font-size: 10pt;">The investigators also found that people with blood pressure levels in the hypertensive range had a significantly lower risk of developing dementia compared to people with blood pressure in the normal range.&nbsp; The association was independent of whether participants were taking medications that treat hypertension.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In our study, high blood pressure is not a risk factor for dementia in the oldest old, but just the opposite,&rdquo; says Corrada. &ldquo;Developing hypertension at older ages may be beneficial for maintaining intact cognition through mechanisms related to cerebral perfusion or to vascular or other pathologies. It is important to understand these mechanisms, because recommendations for healthy blood pressure in the oldest old may turn out to differ from those in younger people.&rdquo;</span></p></div> Cataract surgery improves not only vision but cognition and quality of life in dementia patients 2014-07-14T10:25:00Z 2014-07-14T10:25:00Z <div id="Introduction18" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Cataract surgery for people with Alzheimer&rsquo;s disease and other dementias not only improves vision but can slow decline in cognition and improve quality of life for both people with the disease and their caregivers, according to clinical trial results reported at the Alzheimer&rsquo;s Association International Conference&nbsp;2014 (AAIC) in&nbsp;Copenhagen, Denmark.</strong></span></p> </div><div id="Text118" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This study supports the Alzheimer&rsquo;s Association view that people with dementia retain, and benefit from, full healthcare treatment,&rdquo; says&nbsp;Maria Carrillo, Alzheimer&rsquo;s Association vice president of Medical and Scientific Relations. &ldquo;Too common attitudes such as, &lsquo;There&rsquo;s no need for extra care&rsquo; or &lsquo;Why put them through all of that&rsquo; are not justified and are bad medical practice.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Appropriate thoughtfulness and restraint are necessary when considering surgery or other procedures for people with Alzheimer&rsquo;s or another dementia. However, we should not assume that medical procedures cannot be pursued or are too risky. As these new results show, improving sensory abilities, for example, can provide benefits in a variety of ways &ndash; for people with Alzheimer&rsquo;s and also for their caregivers from whom unnecessary burden can be lifted,&rdquo; Carrillo says.</span></p> <p><br /><span style="font-size: 10pt;">At AAIC 2014,&nbsp;Alan J Lerner, of&nbsp;Case Western Reserve University&nbsp;and University Hospitals Case Medical Center, and colleagues reported interim results from an ongoing clinical trial to determine the effects of cataract removal on several measures of visual ability, cognitive measures, and quality of life in people with dementia. Study participants are recruited from dementia and ophthalmology clinics at University Hospitals Case Medical Center and MetroHealth Medical Center in&nbsp;Cleveland, Ohio, USA, and are divided into two groups: (1) immediate surgery following recruitment and (2) delayed or refused surgery. Vision and cognitive status, mood, and capability to complete daily activities are evaluated at baseline and six months after recruitment, or six months after surgery.</span></p> <p><br /><span style="font-size: 10pt;">Preliminary analysis of results from 20 surgical and eight non-surgical participants showed that the surgical group had significantly improved visual acuity and quality of life, reduced decline in memory and executive functioning, and improvements in behavioural measures compared with the non-surgical group. Levels of perceived burden for caregivers of people in the surgical group also showed improvement.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These preliminary results indicate that improved vision can have a variety of benefits for people with dementia and their loved ones, both visual and non-visual,&rdquo; says Lerner. &ldquo;Our findings need to be verified in a larger study, but they suggest the need to aggressively address dementia co-morbidities such as vision-impairing cataracts, while balancing safety and medical risks.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;If the results hold up, it will significantly affect how we treat cataracts in individuals with dementia. Other interventions to offset sensory loss &ndash; including vision and hearing &ndash; may help improve quality of life for people with dementia and their caregivers,&rdquo; Lerner adds.</span></p></div> New data shows combination therapy is more effective than monotherapy in removing beta-amyloid plaques from the brains of mice 2014-07-14T09:59:00Z 2014-07-14T09:59:00Z <div id="Introduction19" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Eli Lilly and Company has announced results from its non-clinical study in genetically engineered mice examining combination therapy with the murine version of the beta-amyloid antibody N3pG and beta-secretase inhibitor BACE (LY2811376). Data results found that combination therapy was more effective in removing clumps of amyloid-beta protein in the brain &ndash; a component that is thought to lead to Alzheimer&rsquo;s disease &ndash; than use of one therapy. These data were presented at the Alzheimer&rsquo;s Association International Conference 2014 (AAIC 2014) in&nbsp;Copenhagen, Denmark&nbsp;by&nbsp;Ron DeMattos, research fellow in the Neuroscience Division at Eli Lilly and Company.&nbsp;</strong></span></p> </div><div id="Text119" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This non-clinical study demonstrates that by simultaneously targeting two different steps in the beta-amyloid disease process, researchers can slow the progression of Alzheimer&rsquo;s disease pathology in genetically engineered mice,&rdquo; says DeMattos. &ldquo;These results may have a significant impact on the future of Alzheimer&rsquo;s disease therapies as they support the clinical rationale for using future testing of combination therapy against the a-beta protein in the clinical practice.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Alzheimer&rsquo;s disease, the most common form of dementia, causes progressive decline in memory and other aspects of cognition. A number of new investigational mechanisms for the treatment of Alzheimer&rsquo;s disease are currently in development. One type of investigational mechanism, called beta-secretase inhibitors, aims to block the body&rsquo;s ability to produce beta-amyloid protein, a possible component that leads to Alzheimer&rsquo;s disease. The other type of investigational drug is called a beta-amyloid antibody, which targets the removal of the beta-amyloid protein. </span><span style="font-size: 10pt;">Compounds that are thought to work through these mechanisms have been studied in clinical trials on their own; however, most of the trials have not shown significant treatment effects. Therefore, many believe that multiple steps of the beta-amyloid deposition process need to be simultaneously targeted in order to remove significant quantities of the beta-amyloid pathology.</span></p> <p><br /><span style="font-size: 10pt;">The non-clinical study results showed that when used on their own (as monotherapies), the beta-secretase inhibitor and the N3pG beta-amyloid antibody removed approximately 50% of the clumps of amyloid-beta protein, whereas the combination therapy resulted in an even more substantial 86% removal. Additionally, combination therapy significantly lowered deposited A&beta;1-42 75 percent relative to the time zero controls. Histological analyses indicated that the BACE inhibitor monotherapy resulted in removal of diffuse deposits of beta-amyloid, the antibody monotherapy resulted in removal of cored plaques, and the combination therapy removed both the diffuse deposits and cored plaques. Multiple different types of biochemical analyses confirmed that the combination treatment was superior to the monotherapy treatments.&nbsp;</span></p> <p><span style="font-size: 10pt;"><strong><br />Study Methods<br /> <br /></strong>Aged PDAPP transgenic mice (17-19 months) were randomised into the following five cohorts: 1) time zero control, 2) large and small molecule compound controls, 3) plaque-specific A&beta; antibody (anti-A&beta;p3-x), 4) BACE inhibitor, and 5) A&beta; antibody + BACE inhibitor. The aged mice were treated for four months with either a beta-secretase inhibitor or the N3pG beta-amyloid antibody, or the combination of the two drugs. Effectiveness of the treatments was determined by measuring the amount of beta-amyloid protein remaining in the brains of the mice.</span></p></div> Post-concussion ‘return to play’ decision for footballers should be made solely by doctors, says new editorial 2014-07-14T09:47:00Z 2014-07-14T09:47:00Z <div id="Introduction20" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>An editorial published in <em><a href="" target="_blank">The Lancet Neurology</a>&nbsp;</em>calls for sports authorities to take into consideration the long-term neurological problems that repeated concussions can cause.</strong></span></p> </div><div id="Text120" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Cerebral concussion is the most common form of sports-related traumatic brain injury, and the long-term effects of repeated concussions may include dementia, amyotrophic lateral sclerosis, and other neurological disorders, say the journal editors.</span></p> <p><br /><span style="font-size: 10pt;">However, what is perhaps more concerning, is that even when the symptoms of concussion are delayed, or if they come and go quickly, neurological damage can remain without detection. This can lead to footballers, such as Uruguayan defender &Aacute;lvaro Pereira during the 2014 FIFA World Cup, overruling doctors&rsquo; advice to be substituted and returning to play after sustaining a head injury.</span></p> <p><br /><span style="font-size: 10pt;">The journal editors argue that the decision for players to return to a game after sustaining a concussion should be made only by healthcare professionals, and &ldquo;should surely be taken out of the hands of those with a vested interest in the player&rsquo;s performance.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to the journal editors, &ldquo;Many sporting organisations now acknowledge the potentially serious consequences of mild traumatic brain injury and have drawn up new protocols to protect athletes who sustain a head injury. However FIFPro, the world players&rsquo; union, has called for an investigation of concussion protocols and return-to-play standards following Pereira&rsquo;s injury.&rdquo;</span></p></div> Cinnamon may be used to halt the progression of Parkinson’s disease 2014-07-11T16:50:00Z 2014-07-11T16:50:00Z <div id="Introduction21" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neurological scientists at Rush University Medical Center have found that using cinnamon, a common food spice and flavouring material, can reverse the biomechanical, cellular and anatomical changes that occur in the brains of mice with Parkinson&rsquo;s disease. The results of the study were recently published in the June 20 issue of the&nbsp;<a href="" target="_blank"><em>Journal of Neuroimmune Pharmacology</em></a>.</strong></span></p> </div><div id="Text121" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Cinnamon has been used widely as a spice throughout the world for centuries,&rdquo; says Kalipada Pahan, study lead researcher and the Floyd A Davis professor of neurology at Rush. &ldquo;This could potentially be one of the safest approaches to halt disease progression in Parkinson&rsquo;s patients.&rdquo;</span></p> <p><span style="font-size: 10pt;">&ldquo;Cinnamon is metabolised in the liver to sodium benzoate, which is an FDA-approved drug used in the treatment for hepatic metabolic defects associated with hyperammonemia,&rdquo; says Pahan. It is also widely used as a food preservative due to its microbiocidal effect.</span></p> <p><br /><span style="font-size: 10pt;">Chinese cinnamon (Cinnamonum cassia) and original Ceylon cinnamon (Cinnamonum verum) are two major types of cinnamon that are available in the USA.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Although both types of cinnamon are metabolised into sodium benzoate, by mass spectrometric analysis, we have seen that Ceylon cinnamon is much more pure than Chinese cinnamon as the latter contains coumarin, a hepatotoxic molecule,&rdquo; says Pahan.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Understanding how the disease works is important to developing effective drugs that protect the brain and stop the progression of Parkinson&rsquo;s disease,&rdquo; says Pahan. &ldquo;It is known that some important proteins like Parkin and DJ-1 decrease in the brain of Parkinson&rsquo;s disease patients.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />The study found that after oral feeding, ground cinnamon is metabolised into sodium benzoate, which then enters into the brain, stops the loss of Parkin and DJ-1, protects neurons, normalises neurotransmitter levels, and improves motor functions in mice with Parkinson&rsquo;s disease.</span></p> <p><br /><span style="font-size: 10pt;">This research was supported by grants from National Institutes of Health.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Now we need to translate this finding to the clinic and test ground cinnamon in patients with Parkinson&rsquo;s disease. If these results are replicated in Parkinson&rsquo;s disease patients, it would be a remarkable advance in the treatment of this devastating neurodegenerative disease,&rdquo; says Pahan.</span></p></div> Northwestern Medicine enrols first participant in study of device to treat brain aneurysms 2014-07-11T16:22:00Z 2014-07-11T16:22:00Z <div id="ImageMain22" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction22" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Northwestern Medicine&nbsp;is participating in a multicentre US clinical trial to evaluate the safety and effectiveness of the Microvention FRED flow diversion system (Flow Re-Direction Endoluminal Device) for the treatment of wide-necked intracranial aneurysms.&nbsp;The trial involves inserting a&nbsp;small, metallic mesh tube via a micro-catheter into the blood vessel across the entrance to the aneurysm. The device contains the flow of blood within the tube to keep it away from the aneurysm. This causes the aneurysm to clot and minimises the chance of rupture.</strong></span></p> </div><div id="Text122" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Bernard R Bendok, a neurological surgeon at Northwestern Memorial, performed&nbsp;the first surgery on 12 March. The patient was released from the hospital three days later and continues to recover.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Historically, large aneurysms are particularly difficult to treat,&rdquo; says Bendok, who is also a professor of neurological surgery, radiology and otolaryngology at&nbsp;Northwestern University Feinberg School of Medicine.&nbsp;&ldquo;This new device system may offer additional benefits over first generation flow diversion devices because it can be partially deployed, retrieved and accurately repositioned or redeployed to ensure the most precise placement.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The results of this national trial could change the way large aneurysms are treated in a way that is a huge benefit to the patient,&rdquo; Bendok adds. &ldquo;Not only is this safer, it is less invasive, which drastically cuts recovery time. We&nbsp;are thrilled to offer participation in this study to our patients.&rdquo;</span></p></div> NIH funds phase II trial for treatment of ADHD with Monarch eTNS system 2014-07-11T16:08:00Z 2014-07-11T16:08:00Z <div id="Introduction23" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroSigma has announced that the US National Institutes of Health (NIH) has awarded&nbsp;UCLA&nbsp;a grant that funds a phase II 90-subject paediatric clinical trial at the&nbsp;University of California, Los Angeles&nbsp;(UCLA) focused on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) with NeuroSigma&rsquo;s Monarch external trigeminal nerve stimulation (eTNS) system.</strong></span></p> </div><div id="Text123" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">James McGough, professor of Psychiatry and Biobehavioral Sciences at&nbsp;UCLA, will lead the study as principal investigator, with&nbsp;Sandra Loo, associate professor, as co-principal investigator. Their earlier phase I trial of eTNS for the treatment of ADHD, funded by NeuroSigma, found significant improvements in the severity of ADHD symptoms with eight weeks of nightly eTNS therapy.&nbsp;This phase II clinical trial will evaluate eTNS as monotherapy, under double-blind conditions, in up to 90 children, ages eight to 12, in a four week randomised clinical trial conducted at UCLA.&nbsp;NeuroSigma will provide eTNS systems to&nbsp;UCLA&nbsp;in support of the trial.&nbsp;Neither McGough nor Loo has any affiliation with NeuroSigma.</span></p> <p><span style="font-size: 10pt;"><br />ADHD usually arises in childhood.&nbsp;The US Center for Disease Control and Prevention (CDC) has reported national survey findings that approximately 11% of children ages four to 17 have been diagnosed with the disorder, and that about one in five high school boys will receive this diagnosis during childhood.&nbsp;Symptoms include difficulty paying attention in school, at play, or in the home, a reluctance to take on tasks that require sustained mental effort, being easily distracted, exhibiting physical hyperactivity, and engaging in impulsive behaviours.&nbsp;These symptoms may interfere with social, school, or work functioning.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;I am very pleased that the NIH has funded this extremely important phase II clinical trial in ADHD.&nbsp;Millions of parents seek alternatives to drug treatment for their children with ADHD that are safe and non-invasive,&rdquo; says Leon Ekchian, NeuroSigma&rsquo;s president and chief executive officer.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;McGough and Loo are to be congratulated for receiving this grant, particularly at a time when the NIH budget is under pressure to fund only the most promising lines of investigation. NIH awards represent one of the most stringent forms of peer review in biomedical science,&rdquo; notes&nbsp;Ian Cook, NeuroSigma&rsquo;s chief medical officer and senior vice president.&nbsp;&ldquo;Besides showing safety of eTNS in children, their phase I study found a significant impact on the clinical symptoms of ADHD, and substantial improvements on sleep as well as several objective computer-based measures of cognitive performance.&nbsp;We look forward to confirming these results in this phase II clinical trial under double-blind controlled conditions. A neuromodulation treatment option for ADHD could avoid concerns about the exposure of children to the psychostimulant medications that are the current first-line treatments.&rdquo;&nbsp;</span></p></div> New US patent for Barrel vascular reconstruction device 2014-07-11T15:32:00Z 2014-07-11T15:32:00Z <div id="Introduction24" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Reverse Medical Corporation has announced that the United States Patent Office has notified the company that a new patent has issued entitled &ldquo;Protuberant Aneurysm Bridging Device and Method of Use&rdquo;. This new patent grants six claims surrounding the use of the company&rsquo;s Barrel vascular reconstruction device technology platform.</strong></span></p> </div><div id="Text124" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Reverse Medical Barrel vascular reconstruction device represents a proprietary technology designed specifically for treating complex intracranial bifurcation artery anatomy. The Barrel design is unique, essentially reducing the neck size of wide-neck bifurcation aneurysms, enabling traditional coil embolisation, a craft already mastered by the neuro interventionalist, while maintaining patency of all involved vasculature.</span></p> <p><br /><span style="font-size: 10pt;">Commenting on this new patent, Reverse Medical chief technology officer Brian Strauss says, &ldquo;This patent solidifies our intellectual property foundation of unique means for treating wide-neck bifurcation aneurysms, and along with our other issued patents and pending applications, provides us with broad protection for our innovative device portfolio for treating a variety of neuro and peripheral vascular conditions.&rdquo;</span></p></div> High stress, hostility, depression linked with increased stroke risk 2014-07-11T09:50:00Z 2014-07-11T09:50:00Z <div id="ImageMain25" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction25" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Higher levels of stress, hostility and depressive symptoms are associated with significantly increased risk of&nbsp;stroke&nbsp;or transient ischaemic attack in middle-age and older adults, according to new research in the American Heart Association journal&nbsp;<em><a href="" target="_blank">Stroke</a>.</em></strong></span></p> </div><div id="Text125" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A transient ischaemic attack is a stroke caused by a temporary blockage of blood flow to the brain.</span></p> <p><br /><span style="font-size: 10pt;">Researchers investigated how psychological factors might influence risk for chronic disease, using data from the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing study on cardiovascular disease risk factors in participants living in six US cities.</span></p> <p><br /><span style="font-size: 10pt;">More than 6,700 adults (ages 45-84; 53% women) completed questionnaires assessing chronic stress, depressive symptoms, anger and hostility over two years. Participants were 38.5% white, 27.8% African-American, 11.8% Chinese and 21.9% Hispanic. All were free of cardiovascular disease at the start of the study.</span></p> <p><br /><span style="font-size: 10pt;">In follow-up for an additional 8.5 to 11 years, 147 strokes and 48 transient ischaemic attacks occurred.</span></p> <p><br /><span style="font-size: 10pt;">Compared to people with the lowest psychological scores, those with highest scores were:</span></p> <ul> <li><span style="font-size: 10pt;">86% more likely to have a stroke or transient ischaemic attack for high depressive symptoms.</span></li> <li><span style="font-size: 10pt;">59% more likely to have a stroke or transient ischaemic attack for the highest chronic stress scores.</span></li> <li><span style="font-size: 10pt;">More than twice as likely to have a stroke or transient ischaemic attack for the highest hostility scores.</span></li> </ul> <p><span style="font-size: 10pt;">No significant increased risk was linked to anger.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;There is such a focus on traditional risk factors &mdash; cholesterol levels, blood pressure, smoking and so forth &mdash; and those are all very important, but studies like this one show that psychological characteristics are equally important,&rdquo; says Susan Everson-Rose, study lead author and associate professor of medicine at the University of Minnesota in Minneapolis, USA.</span></p> <p><br /><span style="font-size: 10pt;">These associations noted in the study were significant even when researchers accounted for age, race, sex, health behaviours and other known risk factors of stroke.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Given our ageing population, it is important to consider these other factors that might play a role in disease risk. Stroke is a disease of the elderly predominantly, and so learning more about things that can influence risk for stroke as people age is important.&rdquo;</span></p> <p><span style="font-size: 10pt;">Researchers measured chronic stress in five domains: personal health problems, health problems of others close to the participant, job or ability to work, relationships and finances.</span></p> <p><br /><span style="font-size: 10pt;">They assessed depressive symptoms with a 20-question scale and analysed anger with a 10-item scale that captured the extent and frequency of experiencing that emotion. Hostility, which is a negative way of viewing the world, was measured by assessing a person&rsquo;s cynical expectations of other people&rsquo;s motives.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;One thing we did not assess is coping strategies,&rdquo; Everson-Rose says. &ldquo;If someone is experiencing depressive symptoms or feeling a lot of stress or hostility, we don&rsquo;t know how they manage those, so it&rsquo;s possible that positive coping strategies could ameliorate some of these associations or effects,&rdquo; she says. &ldquo;We did not inquire about coping. I would say that is one of the tasks for future studies.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Researchers did not identify potential racial and ethnic differences or sex differences in the observed associations, but were not able to fully examine such differences due to the smaller numbers of strokes in some groups.</span></p> <p><br /><span style="font-size: 10pt;">Co-authors are Nicholas Roetker; Pamela Lutsey; Kiarri Kershaw; W T Longstreth Jr; Ralph Sacco; Ana Diez Roux; Alvaro Alonso. Author disclosures are on the manuscript.</span></p> <p><br /><span style="font-size: 10pt;">The National Heart, Lung, and Blood Institute funded the study.</span></p></div> Less-invasive technique repairs life-threatening condition 2014-07-10T10:14:00Z 2014-07-10T10:14:00Z <div id="Introduction26" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A patient who underwent a less-invasive technique to repair an arteriovenous fistula was able to return to work just two weeks after surgery.</strong></span></p> </div><div id="Text126" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">What enabled the patient, Bill Abt to recover so quickly and painlessly was a less-invasive surgical technique performed by Loyola University Medical Center neurosurgeon William W Ashley, Jr.</span></p> <p><br /><span style="font-size: 10pt;">The less-invasive technique Ashley performed was an endovascular treatment. He inserted a catheter in an artery in the groin, then guided the catheter up past the heart and through the carotid artery into the brain. Once the catheter reached the fistula, Ashley injected a liquid polymer that immediately solidified. This effectively sealed off the fistula to prevent a possible rupture.</span></p> <p><br /><span style="font-size: 10pt;">The case began when Abt consulted a physician about tinnitus (chronic ringing in his ear). The physician ordered a scan, which detected the arteriovenous fistula.</span></p> <p><br /><span style="font-size: 10pt;">Normally, arteries and veins are separate, with arteries transporting high-pressure blood from the heart to the body&rsquo;s organs, and veins carrying low-pressure blood back to the heart. But in Abt&rsquo;s case, an artery in his brain was directly connected to a vein. Consequently, high-pressure blood was shooting into the vein -- like a fire hose connected to a garden hose. The thin-walled vein, not designed to withstand such pressure, ballooned outward and was at risk of rupturing. Blood leaking from such a rupture could have caused a debilitating or fatal stroke.</span></p> <p><br /><span style="font-size: 10pt;">Christopher Loftus, chair of the Department of Neurological Surgery presented the case to a multidisciplinary cerebrovascular conference. Loftus led the discussion as physicians carefully examined the risks and benefits of all options, including traditional open surgery, the less-invasive endovascular treatment or no treatment at all. Loftus decided to bring Ashley in on the case.</span></p> <p><br /><span style="font-size: 10pt;">Abt underwent the less-invasive endovascular treatment on a Friday. He went home the next day, and began working from home the following week. The second week, he returned to work as senior vice president for administration and business at Carthage College in Kenosha, USA.</span></p></div> Treating oxygen-deprived newborns with hypothermia improves survival without brain damage in later childhood 2014-07-10T09:34:00Z 2014-07-10T09:34:00Z <div id="ImageMain27" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction27" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The cooling of newborn babies suffering from perinatal asphyxia &ndash; a lack of oxygen at the time of birth &ndash; significantly increases their chance of survival without brain damage to later childhood (age six to seven years), according to a Medical Research Council (MRC) funded clinical trial.</strong></span></p> </div><div id="Text127" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study, published in the&nbsp;<a href="" target="_blank"><em>New England Journal of Medicine</em></a>, found that 51.7% of infants treated with hypothermia survived with an IQ of 85 or above, which is considered to be within the normal range, compared to 39.4% of those treated with standard care. Cooling significantly reduced the chance of oxygen-deprived children suffering from cerebral palsy and other moderate/severe disabilities. The children also showed improved motor functioning. However, the authors observed that there was no difference in mortality rate &ndash; reported to be around 30% of children enrolled in the trial &ndash; between the standard care and hypothermia-treated groups.</span></p> <p><span style="font-size: 10pt;"><br />The trial, led jointly by the National Perinatal Epidemiology Unit (NPEU) at the University of Oxford and Imperial College London, is the largest study of its kind and the first study to show improved brain function in children treated using this method in later life<strong>. </strong>Before this trial, there was limited information on the beneficial effect of cooling after asphyxia beyond the age of 18 months. This work is important because it demonstrates that the improvements observed in brain function are not just temporary.</span></p> <p><span style="font-size: 10pt;"><br />The <a href="" target="_blank"><strong>MRC TOBY</strong></a> trial (Total body hypothermia) involved newborn babies of at least 36 weeks gestation that suffered from a lack of oxygen at birth. The children were randomly assigned into two groups within six hours of delivery, and either treated with standard care or standard care plus hypothermia, when their body temperature was reduced to 33.5˚C for 72 hours. After that time, they were slowly returned to a normal body temperature of 37˚C.</span></p> <p><span style="font-size: 10pt;"><br />The current research is part of the follow up <a href="" target="_blank"><strong>TOBY Children Study</strong></a> that aimed to find out if there were any differences in the health of the children, treated with or without cooling, in later life. The scientists tested the children&rsquo;s mental abilities and performance at school, looked at parent and teacher reports on behaviour and investigated the presence and severity of any disabilities that resulted from oxygen deprivation.</span></p> <p><span style="font-size: 10pt;"><br />Following oxygen deprivation a number of processes are set off in the brain, which lead to brain cell death and permanent neurological damage. Hypothermia interrupts these processes to reduce brain injury and has consistently been shown to improve outcomes at 18 months. This study now confirms treatment with cooling is safe and effective, and that the benefits persist in the long term. The treatment has been endorsed by the National Institute for Health and Care Excellence (NICE) and adopted into clinical practice in the NHS; it has the advantage of being relatively simple and inexpensive to carry out.&nbsp;These new findings support its general use in neonatal clinical practice.</span></p> <p><span style="font-size: 10pt;"><br />Denis Azzopardi, of King&rsquo;s College London and lead author of the study, says: &ldquo;This study is important as it confirms improved brain function persisting into middle childhood with cooling treatment and it is a proof of the concept that treatment following oxygen deprivation at birth can be effective.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Brenda Strohm, research nurse and TOBY trial coordinator at the NPEU, University of Oxford, says: &ldquo;We are indebted to all the families who took part in the TOBY Trial and then the TOBY Children Study; their contribution to these two important studies has made a real difference to neonatal care.&rdquo;&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;While corresponding with the families over the years, I have shared many happy stories of achievement and success as well as moments of sadness and loss; this is a privilege which adds a special dimension to my role of study co-ordinator. Thanks to our latest research, now when a baby is treated with cooling, families can be more fully informed about what might lie ahead, not only in the coming months but in the next few years too.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Hugh Perry, chair of the MRC Neurosciences and Mental Health Board, says: &ldquo;This study is a great example of how research can change people&rsquo;s lives. Although major advances have been made in how childbirth is managed, approximately two out of every 1,000 newborn infants suffer from a lack of oxygen around the time of birth. Prior to the introduction of cooling therapy there were no approved, specific treatments that reduced the risk of brain injury long-term following asphyxia.<strong>&rdquo;</strong></span></p></div> Advances in trigeminal nerve stimulation featured at European congress on epileptology 2014-07-09T14:49:00Z 2014-07-09T14:49:00Z <div id="Introduction28" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroSigma has announced top-line summaries of presentations made at the 11th European Congress on Epileptology in&nbsp;Stockholm, Sweden, related to the use of external trigeminal nerve stimulation (eTNS) in epilepsy.</strong></span></p> </div><div id="Text128" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Sean Slaght reported an update of observational findings in on-going adjunctive treatment with eTNS of adults at&nbsp;Kings College&nbsp;London, UK.&nbsp;In a group of 13 real-world, care-seeking patients with drug resistant epilepsy, who completed at least 12 weeks of nightly use of the Monarch eTNS system, they observed a median reduction in seizure frequency of 38%. The Kings College London researchers additionally reported on significant improvement in quality of life, mood, and sleep metrics.</span></p> <p><br /><span style="font-size: 10pt;">In the first-ever use of eTNS in paediatric patients with drug resistant epilepsy, Slaght reported preliminary findings on seven children, age 10 to 17, treated with this non-invasive, adjunctive therapy. Three children (43% of the group) reported a 50% or more reduction of their seizure frequency after 18 weeks.</span></p> <p><br /><span style="font-size: 10pt;">Observational findings were also presented by Jos&eacute; Serratosa, from the Fundaci&oacute;n Jim&eacute;nez D&iacute;az University Hospital,&nbsp;Madrid, Spain.&nbsp;In a group of eight adult patients treated with eTNS, 25% experienced a decrease in seizures of over 90%.</span></p> <p><br /><span style="font-size: 10pt;">Consistent with earlier phase I and II trials conducted in&nbsp;the United States, the European groups reported an absence of serious adverse events.</span></p> <p><span style="font-size: 10pt;"><br />Other investigators from Kings College London reported data on measures of cortical excitability in five adult drug resistant epilepsy patients undergoing eTNS treatment for 18 weeks. Brief magnetic pulses were used to assess cortical function before and after a course of treatment, in an effort to evaluate the mechanism of action of eTNS.&nbsp;&nbsp;Adam Pawley presented work conducted with Mark Richardson&nbsp;at Kings College London.&nbsp;Measures of cortical excitability consistently decreased with use of eTNS, implicating potential effects on signalling in both GABA<sub>A</sub>- and GABA<sub>B</sub>-mediated circuits. Other antiepileptic therapies have previously been shown to reduce measures of cortical excitability.</span></p> <p><br /><span style="font-size: 10pt;">Christianne Heck from the&nbsp;University of Southern California&nbsp;(USC),&nbsp;Los Angeles, chaired a satellite symposium, &ldquo;Trigeminal Nerve Stimulation (TNS): Neuromodulation for the 21st Century.&rdquo; This session introduced TNS to a large number of epileptologists attending the Congress and provided them with both background neurobiological data and clinical results.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The experience at these leading European epilepsy centres bears out the safety profile we have seen in the USA for eTNS, and provides confirmatory evidence of the effects of eTNS on seizures, mood, sleep, and quality of life,&rdquo; says&nbsp;Christopher DeGiorgio, NeuroSigma&rsquo;s vice president of Neurology and the professor of Neurology who first investigated eTNS for drug resistant epilepsy at the&nbsp;University of California, Los Angeles&nbsp;(UCLA).&nbsp;&ldquo;Millions of people living with epilepsy are still having seizures despite the best medication treatment available, often facing cognitive side effects from multiple antiepileptic drugs and the disease itself.&nbsp;eTNS may become an important tool to address this unmet medical need.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;While these studies were of modest size, the researchers conducting these independent effectiveness evaluations are in the vanguard in providing important data that complement the findings from controlled clinical trials. These findings provide us with confidence in the design of the pivotal trial in drug resistant epilepsy that we are preparing to commence. &nbsp;Further, the work with cortical excitability elucidates another biological mechanism by which eTNS may achieve its anticonvulsant effect, and builds on the data showing acute changes in regional brain activity observed with PET scanning at&nbsp;UCLA,&rdquo; adds&nbsp;Ian Cook, chief medical officer and senior vice president at NeuroSigma.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">NeuroSigma provided eTNS Systems to the investigators&rsquo; institutions, but was otherwise uninvolved in the conduct of the research at either Kings College London or the Fundaci&oacute;n Jim&eacute;nez D&iacute;az University Hospital.</span></p></div> Brainlab announces launch of Right.Brain Foundation 2014-07-09T14:26:00Z 2014-07-09T14:26:00Z <div id="ImageMain29" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction29" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Brainlab has announced the launch of the Right.Brain Foundation, which will provide medical technology and education to selected hospitals and public institutions in Southeast Asia, Africa, Central and South America.</strong></span></p> </div><div id="Text129" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Countries were reviewed carefully and selected based on several criteria including: per capita income, reliable energy supply, adequately trained healthcare professionals; keeping in mind the distribution of wealth, political stability and safety of the country as well as where patients may be able to benefit the most from providing treatment.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We understand and acknowledge the World Health Organisation&rsquo;s principles for a good medical equipment donation,&rdquo; says Stefan Vilsmeier, president and chief executive officer, Brainlab. &ldquo;The Right.Brain Foundation, which provides the equipment and trained personnel to the hospitals in need, also includes personnel training at the local hospital level. This helps further their education, provide hope for their country, and raise the bar in academic achievements for residents and studying physicians.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Right.Brain Foundation purpose, &ldquo;Together we provide medical technology to create opportunities for a better world,&rdquo; dovetails perfectly with the Brainlab vision to increase access to and consistency of treatment for patients everywhere. Brainlab is committed to supporting Right.Brain by providing on-point, frugal technologies that will make the most impact in the countries to be served. The technology that will be loaned to the hospitals is Kick Purely Navigation, a robust, reliable and minimalist image guided surgery system that is compact and can be easily shipped. Engineered with focused functionality, Kick is small but powerful and supports and advances neurosurgery efforts in developing countries.</span></p> <p><br /><span style="font-size: 10pt;">Right.Brain will partner with hospitals and physicians in North America and Europe, building an exchange programme to help teach the physicians in developing countries how to use the technology effectively. Furthermore, Brainlab employees will volunteer their vacation time to Right.Brain to provide additional on-site training and support to the local hospitals.</span></p> <p><br /><span style="font-size: 10pt;">Beyond time donations, Brainlab employees are also encouraged to give to Right.Brain via a variety of opportunities such as frequent flyer-mile donations, monetary donations at the Brainlab Open House on Friday, 11 July, 2014 in Feldkirchen, Germany and merchandise available at where 20% of the proceeds will be donated to the Right.Brain Foundation. In the near future, Brainlab will extend support opportunities to current business partners to further the mission of Right.Brain with additional technologies, training and education.</span></p> <p><br /><span style="font-size: 10pt;">The inaugural Right.Brain project will take place at the Calmette Hospital in Phnom Pehn, Cambodia. For this operation, Right.Brain will cooperate closely with La Cha&icirc;ne de l&rsquo;Espoire, a French foundation which is locally based and will ensure a smooth integration of Brainlab technology and help ensure the mission&rsquo;s success.</span></p> <p><br /><span style="font-size: 10pt;">This announcement is the culmination of a passionate idea long held by Brainlab Founder and chief executive officer, Stefan Vilsmeier and just the beginning of the company&rsquo;s social impact journey. This year, as the company celebrates 25 years of medical technology innovation, Brainlab expands its reach beyond the 80 countries currently served to include developing countries in need of the right medical technology to make a difference.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This mission has been 25 years in the making; it extends beyond the walls of our corporate offices and the hospitals we traditionally serve.&rdquo; Vilsmeier adds. &ldquo;This project is unlike any other effort in which Brainlab has participated. Right.Brain will bring technology into underserved areas, connect experienced surgeons and staff with those in need of training and support and most importantly, help patients in need. In five years, we hope to have 80% of the countries using some type of surgical navigation and more patients benefiting from neurosurgical care.&rdquo;</span></p></div> InspireMD announces completion of CGuard CARENET trial 2014-07-09T10:13:00Z 2014-07-09T10:13:00Z <div id="ImageMain30" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction30" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>InspireMD has announced that it has concluded enrolment in its CARENET (Carotid embolic protection study using MicroNet) clinical trial. The multi-specialty trial is assessing the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The acute procedural performance of the CGuard device was 100% successful for all of the 30 patients enrolled in the trial.</strong></span></p> </div><div id="Text130" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Thirty patients were enrolled at four sites across Europe and will be followed up using traditional assessments post-procedure and at 30 days to include MACE (death, stroke, MI), and ipsilateral stroke (31 days to one year).&nbsp; In addition, DW-MRI (Diffusion Weighted Magnetic Resonance Imaging) is being done pre and post procedure and at 30 days, as well as ultrasound examination at 30 days and one year on every patient.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The proprietary CGuard carotid embolic protection system uses the same MicroNet technology featured on the MGuard and MGuard Prime coronary embolic protection systems. The MicroNet technology is a single fibre knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes. The size, or aperture, of the MicroNet &rsquo;pore&rsquo; is only 150-180 microns in order to maximise protection against the potentially dangerous plaque and thrombus within the carotid artery.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;I am excited that enrolment in the CGuard CARENET study has just been completed. I have treated many patients with carotid artery disease over the years and the unique CGuard embolic protection system with MicroNet has changed the way I think about treating these challenging patients,&rdquo; states Joachim Schofer, from the Hamburg University Cardiovascular Center, in Hamburg, Germany. &ldquo;The experience that we have gained using the CGuard device has given us a sense of confidence in regards to new technology options when treating these patients. The small pore size of the MicroNet technology allows excellent blood flow while trapping potentially harmful plaque debris and thrombus. The CGuard technology provides an elegantly simple solution for embolic protection that has not been available in the past. I look forward to reviewing and analysing all of the CARENET data over the next several weeks and sharing the results soon afterward.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The completion of the CGuard CARENET trial on schedule with 100% procedural success rate is an important milestone for InspireMD,&rdquo; states Alan Milinazzo, president and chief executive officer of InspireMD, &ldquo;Our investigators have done a wonderful job throughout this trial, and their feedback on the CGuard has been very positive and informative. The initial results support our belief that the MicroNet technology may deliver life-saving benefits to patients with carotid artery disease and revolutionise the way the carotid stenting procedures are performed. We are looking forward to analysing the data from the CARENET trial and sharing the results in mid-September at the upcoming TCT conference.&rdquo;</span></p></div> SMC says yes to Lemtrada 12mg IV for adults with active relapsing-remitting multiple sclerosis 2014-07-08T10:56:00Z 2014-07-08T10:56:00Z <div id="ImageMain31" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction31" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Scottish Medicines Consortium (SMC) has published its advice that Lemtrada has been accepted for use within NHS Scotland for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS), with active disease defined by clinical or imaging features.</strong></span></p> </div><div id="Text131" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;RRMS accounts for 85% of all initial diagnoses in multiple sclerosis. We are pleased that after many years in development, Lemtrada is now available to patients in Scotland. This provides people with multiple sclerosis with an important and innovative treatment option to consider in partnership with their multiple sclerosis specialists.&rdquo; says Amy Bowen, director of Service Development at the MS Trust. </span><br /><br /><span style="font-size: 10pt;">There are approximately 10,000 people living with multiple sclerosis in Scotland. The majority of people with RRMS experience approximately one or two relapses per year. Around half of all relapses may leave people with lingering problems and disability may accumulate over time. </span><br /><br /><span style="font-size: 10pt;">Lemtrada is the second of Genzyme&rsquo;s treatments for multiple sclerosis to receive approval for use from the SMC and become available for use within NHS Scotland. Lemtrada has also been approved by NICE and is available for NHS patients in England &amp; Wales.</span></p> </div> UK researchers take new steps towards Alzheimer’s blood test 2014-07-08T10:39:00Z 2014-07-08T10:39:00Z <div id="Introduction32" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at King&rsquo;s College London and co-funded by Alzheimer&rsquo;s Research UK have announced a panel of 10 proteins that could form a blood test to predict those most likely to develop Alzheimer&rsquo;s. The research is the result of an international collaboration involving Proteome Sciences and funded by Alzheimer&rsquo;s Research UK, the MRC and NIHR Maudsley Biomedical Research Centre. The study is published on 8 July in the journal <a href="" target="_blank"><em>Alzheimer&rsquo;s and Dementia</em></a>.</strong></span></p> </div><div id="Text132" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">There is currently a large focus in the research community on developing simple and accurate tests that could detect Alzheimer&rsquo;s early or predict who may go on to develop the disease. Alzheimer&rsquo;s changes are known to start in the brain 10 to 15 years before symptoms show and so detecting the disease early could give new treatments the best chance of success.</span></p> <p><br /><span style="font-size: 10pt;">Simon Lovestone, now at Oxford University, and his team studied blood samples from 1,148 volunteers. Of the participants, 452 did not have dementia, 476 had Alzheimer&rsquo;s and 220 had mild cognitive impairment (MCI). Mild cognitive impairment is a term used to describe early memory and thinking problems, which do not necessarily lead onto Alzheimer&rsquo;s, but can put people at a higher risk of the disease. Some of the volunteers also had brain scans to look for tell-tale signs of Alzheimer&rsquo;s in the brain.</span></p> <p><br /><span style="font-size: 10pt;">The researchers analysed blood samples from the volunteers for 26 proteins previously linked to Alzheimer&rsquo;s disease. They found that several of these proteins associated with brain shrinkage on brain scans in people with mild cognitive impairment and Alzheimer&rsquo;s. Taking their research a step further, the team investigated whether any of the proteins could predict the progression from mild cognitive impairment to Alzheimer&rsquo;s. They discovered a panel of 10 proteins that were able to predict which volunteers with mild cognitive impairment would go on to develop Alzheimer&rsquo;s within a year.</span></p> <p><br /><span style="font-size: 10pt;">Abdul Hye, lead author of the study from the Institute of Psychiatry at King&rsquo;s College London, says: &ldquo;Memory problems are very common, but the challenge is identifying who is likely to develop dementia. There are thousands of proteins in the blood, and this study is the culmination of many years&rsquo; work identifying which ones are clinically relevant. We now have a set of 10 proteins that can predict whether someone with early symptoms of memory loss, or mild cognitive impairment, will develop Alzheimer&rsquo;s disease within a year, with a high level of accuracy.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Simon Lovestone, senior author of the study from the University of Oxford, who led the work whilst at King&rsquo;s, says: &ldquo;Alzheimer&rsquo;s begins to affect the brain many years before patients are diagnosed with the disease. Many of our drug trials fail because by the time patients are given the drugs, the brain has already been too severely affected. A simple blood test could help us identify patients at a much earlier stage to take part in new trials and hopefully develop treatments which could prevent the progression of the disease. Our next step will be to test our findings in even larger sample sets, to further improve accuracy and reduce the risk of misdiagnosis, before we can develop a reliable test suitable to be used by doctors.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Eric Karran, director of Research at Alzheimer&rsquo;s Research UK, the UK&rsquo;s leading dementia research charity, says:</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;As the onset of Alzheimer&rsquo;s is often slow and subtle, a blood test to identify those at high risk of the disease at an early stage would be of real value. Detecting the first signs of Alzheimer&rsquo;s could improve clinical trials for new treatments and help those already concerned about their memory, but we are not currently in a position to use such a test to screen the general population.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;It is promising to see research taking us closer to mapping the first changes in Alzheimer&rsquo;s, and the team has pooled data from different studies worldwide to bolster their findings. Many people with mild cognitive impairment will not go on to develop Alzheimer&rsquo;s, but the proteins identified in this panel could help researchers to understand the biology driving the disease in those who do. However, with the risk of misdiagnosis from this panel still high, we would need to see such a test well validated and repeated before it could be used in the clinic.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;With an ageing population, and age the biggest risk factor for Alzheimer&rsquo;s, we are expecting rising numbers of people to be affected over the coming years. It is important to develop new ways to intervene early in the disease to help people maintain their quality of life for as long as possible.&rdquo;</span></p></div> New surgical tool provides hope for patients with inoperable deep bleeding in the brain 2014-07-07T10:15:00Z 2014-07-07T10:15:00Z <div id="ImageMain33" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction33" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Apollo system, manufactured by Penumbra, has been widely launched following first-in-man clinical use at leading US hospitals.</strong></span></p> </div><div id="Text133" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to Penumbra, Apollo is an innovative new surgical tool that enables minimally invasive removal of deeply seated tissue and fluids in the brain during a single, efficient operation. With combined use of an endoscope and image guidance, the Apollo system allows decompression and removal of otherwise inoperable blood clots deep in the brain, among other uses.</span><br /> <br /><span style="font-size: 10pt;"> Alexander Khalessi, assistant professor of surgery and neurosciences at UC San Diego Medical Center and surgical director of Neurocritical Care, successfully treated the first patient in the world using the Apollo device. Khalessi explains: &ldquo;Our first patient was a 41-year-old male who suffered a spontaneous bleeding deep in his brain that completely shifted his ventricular system, interrupted fluid circulation and compressed his midbrain. Despite standard measures including a ventricular catheter to drain fluid, the overall pressure in his brain was not well controlled. Of greater urgency, the patient was essentially comatose with a fixed downward gaze consistent with a Parinaud&rsquo;s syndrome. With evidence of midbrain compression and this clinical sign, we knew this gentleman was at risk for time-sensitive, irreversible damage to the connection between his brain and body.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Large, decompressive open surgeries for this condition are not supported in the published data. Ongoing research efforts include a trial exploring minimally invasive approaches that involve the implantation of a small catheter with gradual removal of the clot over many days. For my patient, I was concerned his need was more urgent, and that the Apollo system would facilitate the same surgical result in minutes, rather than days.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Following successful clot removal with the Apollo system, our patient&rsquo;s gaze improved and we were able to remove brain pressure monitors and breathing support within 48 hours. As opposed to facing several weeks comatose in the intensive care unit, our patient was transferred to the hospital floor, was able to talk to his family, and has since transitioned to a rehabilitation facility.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This initial success led to our use of Apollo in a second, 51-year-old patient with a massive haemorrhage; Apollo facilitated complete removal through a small incision in the eyebrow. He left the intensive care unit within 24 hours and like our first patient, went from a near fatal situation in the hospital, to quickly beginning his recovery in a rehabilitation facility.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;I remain hopeful we are finally making progress in an all too common and horribly disabling and fatal disease,&rdquo; Khalessi concludes.</span></p> <p><span style="font-size: 10pt;"><br />Demetrius Lopes, section chief of Cerebrovascular Neurosurgery at Rush University Medical Center in Chicago, USA, is also an early user. &ldquo;I think the arrival of the Apollo system is very timely. We have had great initial experience in removing intraventricular blood. Use of the Apollo system has resulted in faster patient recovery and a shortened stay in the intensive care unit,&rdquo; explains Lopes.</span></p> <p><br /><span style="font-size: 10pt;">David Fiorella, professor of Clinical Neurological Surgery and Radiology at Stony Brook University Medical Center, discussed his view on the value of the Apollo system and compared it to alternative techniques. &ldquo;Our team at Stony Brook has had tremendous success thus far using the Apollo system, in conjunction with neuroendoscopy and image guidance, for the removal of haemorrhages in the brain. This technique has the potential to be a truly important advance for our field, since no other treatment has convincingly been shown to help patients with this lethal disease. Usually patients with this type of haemorrhagic stroke have very poor outcomes and extremely long hospital stays. Just hours after treatment, our patients began showing improvement, and they continued to improve rapidly during their hospital stays.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;While we were very pleasantly surprised by our patients&rsquo; impressive clinical responses, some data indicates that these types of outcomes might be expected. The investigators in the Minimally invasive surgery and tPA in ICH evacuation (MISTIE II) trial found that when they achieved near complete removal of blood clots (to less than 10 millilitres remaining), they observed higher rates of good clinical outcomes. However, this degree of clot reduction was not achieved in most patients. In addition, with the MISTIE technique, clot reduction required several days of drainage through a small catheter left in place after surgery. With the new Apollo system, it seems that we may be able to achieve the desired level of clot reduction immediately and safely in most patients. Therefore, it is possible that we will continue to observe clinical benefits that surpass our former expectations.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;While these early results are certainly impressive and give us enthusiasm going forward,&nbsp;it is important to recognise that we are very early on in our experience with this procedure. Much more data will be required before we know exactly how effective it is and which patients will benefit most,&rdquo; Fiorella comments.</span></p> <p><br /><span style="font-size: 10pt;">The Apollo system is the result of decades of research and development work in the field of advanced aspiration and vibrational energy technology by researchers at Penumbra. Advanced aspiration technology was first developed and perfected in the field of acute ischaemic stroke where blood clots inside the arteries of the brain are starving brain tissue of vital oxygen and nutrients. The Apollo system adds internal energy generation to a specialised advanced aspiration tool to surgically address deep bleeding in the brain, a particularly devastating form of acute haemorrhagic stroke.</span></p></div> New results show personalised brain tumour vaccine helps patients live longer 2014-07-07T09:53:00Z 2014-07-07T09:53:00Z <div id="Introduction34" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Patients newly diagnosed with glioblastoma multiforme (GBM) and treated with an experimental cancer vaccine made from the patient&rsquo;s own tumour in addition to standard of care lived longer compared to those who received standard of care alone, according to new results from a study involving Northwestern Medicine researchers and released on 1&nbsp;July.</strong></span></p> </div><div id="Text134" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Glioblastomas are fast growing tumours that invade normal brain tissue. The disease is often resistant to treatments such as chemotherapy and radiation and median survival is approximately 15 months from the point of first diagnosis.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Improving the survival for GBM patients is an important goal for many of us here at&nbsp;Northwestern,&rdquo; says the study&rsquo;s principal investigator&nbsp;Andrew Parsa, who is chair of neurological surgery at&nbsp;Northwestern Memorial Hospital&nbsp;and the Michael J Marchese professor and chair of the&nbsp;department of neurological surgery&nbsp;at&nbsp;Northwestern University Feinberg School of Medicine. &ldquo;This brain cancer does not discriminate. It affects all ages, genders and races and less than 5% of glioblastoma patients survive five years. With new research and studies like this, we hope to one day write a different ending to the story by turning this into a chronic disease &ndash; one that can be treated with medication.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Typically, patients newly diagnosed with a glioblastoma undergo surgery to remove their tumour followed by radiation and temozolomide, an oral chemotherapy drug. This phase 2 single-arm trial consisted of 46 patients and added a vaccine made from their tumour to their treatment. The vaccine is unique to each patient and is engineered to trigger an immune system response to kill tumour cells that may remain following surgery. &nbsp;&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Results showed the patients who added the vaccine to their treatment lived longer. More specifically, 50% of the patients enrolled in the trial lived for two years, an encouraging result for a cancer that often kills patients within one year. The patients enrolled in this trial were treated at eight centres across the USA including Northwestern Memorial.</span></p> <p><br /><span style="font-size: 10pt;">Median overall survival for patients enrolled in the trial is 23.8 months. For the standard of care alone, median overall survival rate is 14.6 months. The trial also monitored each patient&rsquo;s progression-free survival, which is the length of time a patient lives with the tumour controlled. Vaccine treated patients had a median progression-free survival of nearly 18 months, approximately two- to three-times longer than patients treated with radiation and temozolomide alone.<sup>&nbsp;&nbsp;</sup>In addition, 22% of patients enrolled in the trial were alive at 24 months and continue to be monitored. &nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Based on the positive phase 2 trial results, Agenus Inc, the biopharmaceutical company&nbsp;developing the vaccine, is exploring partnerships for a randomised, phase 3 trial. A successful trial could lead to the vaccine potentially being approved to treat brain tumours, making it one of only a few approved therapeutic cancer vaccines and treatments for GBM patients.&nbsp;&nbsp; &nbsp;</span></p> <p><br /><span style="font-size: 10pt;">While new findings such as this one continue to extend the lives of patients with glioblastoma, for the moment, it remains one of the most dreaded diagnoses, which is why Parsa, co-leader of the Translational Research in Solid Tumours Programme at the&nbsp;Robert H Lurie Comprehensive Cancer Center of Northwestern University, and other Northwestern Medicine researchers are also studying&nbsp;the vaccine for GMB patients whose tumour returns. &nbsp;The phase 2 recurrent and newly diagnosed trials are being led by Parsa and primarily have been supported through funding from the American Brain Tumor Association, Accelerated Brain Cancer Cure, National Brain Tumor Society and National Cancer Institute Special Programs of Research Excellence.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;A glioblastoma is the most common primary malignant brain tumour and affects up to 17,000 Americans annually,&rdquo; says&nbsp;Jeffrey Raizer, co-director of the Northwestern Brain Tumor Institute, director of medical neuro-oncology at the Lurie Cancer Center and the principal investigator for the study at Northwestern Memorial. &ldquo;Vaccine therapy has the potential to offer a safer and less toxic cancer treatment to patients. While conventional therapies sometimes cause debilitating side effects, this treatment is simply a series of injections that is increasing the survival of patients in early trials.&nbsp;Importantly, it can be combined with other therapies allowing us to attack these tumours from different approaches.&rdquo;</span></p></div> Mazor Robotics receives first order for Renaissance system with brain module 2014-07-07T09:37:00Z 2014-07-07T09:37:00Z <div id="ImageMain35" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction35" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Mazor Robotics has announced that it has received the first order for its Renaissance system since the commercial launch of the brain surgery module.</strong></span></p> </div><div id="Text135" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The system was sold to Bryan Medical Center in Lincoln, Nebraska, USA and will be utilised for spine and brain procedures. Bryan Medical Center is a 640-bed, not-for-profit, locally owned and governed health care organisation serving patients from throughout Nebraska, as well as parts of Kansas, Iowa, South Dakota and other states in the region.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The first order for Renaissance with our brain surgery module is a new milestone for Mazor Robotics. The value proposition offered to our customers enabled our team to achieve the first system placement in the USA, less than three months after we commercially launched the brain application,&rdquo; comments Ori Hadomi, chief executive officer. &ldquo;The versatility of the Renaissance system enables surgeons and hospital administrators to deploy a single proven system for both brain and spine procedures.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The company commercially launched the brain application at the American Association of Neurological Surgeons (AANS) annual meeting in April 2014. Renaissance&rsquo;s brain module is primarily used to assist with deep brain stimulation procedures to treat movement disorders, such as Parkinson&rsquo;s disease. Three other hospitals, including Littleton Adventist (Littleton, Colorado), were utilising the brain application during a pre-launch testing period and continue to use the system for brain surgeries.</span></p></div> Successful combined approach to extensive cerebral venous sinus thrombosis with Penumbra aspiration and Solitaire FR 2014-07-02T14:08:00Z 2014-07-02T14:08:00Z <div id="ImageMain36" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction36" style="clear:both;"> <p><strong><span style="font-size: 11pt;">A combined approach with the Penumbra aspiration system (Penumbra) and the Solitaire FR retrieval device (ev3, Covidien) has been successfully used in a patient with extensive superior sagittal sinus thrombosis and cortical venous thrombosis, according to a case report.&nbsp;</span></strong></p> </div><div id="Text136" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Radoslav Raychev, Division of Interventional Neuroradiology, Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, USA and colleagues, report the successful treatment in the <a href="" target="_blank"><em>Journal of NeuroInterventional Surgery</em></a>.</span><br /><br /><span style="font-size: 10pt;">The novel technique was performed in a young woman with rapid, progressive neurologic decline due to malignant cerebral oedema caused by a cerebral venous sinus thrombosis.</span><br /><br /><span style="font-size: 10pt;">&ldquo;Complete revascularisation of the occluded sinus was achieved using suction thrombectomy with the 5Max Penumbra catheter in combination with the Solitaire retrieval device,&rdquo; describes Raychev <em>et al</em>.</span><br /><br /><span style="font-size: 10pt;">&ldquo;To our knowledge, this is the first reported case describing such a combined mechanical approach to cerebral venous sinus thrombosis. The clot retrieval properties of the Solitaire device combined with direct aspiration via the newest generation Penumbra catheters may allow more rapid, safe and efficient revascularisation than all previously reported endovascular treatments for this potentially devastating condition,&rdquo; they say.</span></p></div> New brain-training app Brain+ launches in the UK 2014-07-02T12:29:00Z 2014-07-02T12:29:00Z <div id="Introduction37" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Brain+, a brain-training programme that outpaces existing apps in engagement, effectiveness and economy for users, is being launched in a brand new version on the 1 July. Free to download, Brain+ is available to iPhone and iPad users through the Apple App Store.</span> </strong></p> </div><div id="Text137" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Brain+ contains a number of scientifically designed, yet fun and motivating mind-training games that improve key mental capabilities in the areas of attention, memory, problem solving and planning. The Brain+ exercises are developed in collaboration with leading brain scientists from Copenhagen University and are suitable for people of all ages.</span><br /> <br /><span style="font-size: 10pt;"> Launched in Denmark in 2013, Brain+ offers a uniquely differentiated and unmatched value proposition in the digital brain-training space by being the first to create and combine a solid scientific foundation with brain-training exercises delivered as games of higher quality and longer-term motivation compared with the simpler exercises in pricier apps already in market.&nbsp;</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Not many people are fully aware of all the possibilities for their brains, but it&rsquo;s very important how you train your brain,&rdquo; says Brain+ chief executive officer Kim Baden-Kristensen. &ldquo;The capacity you build over the years prolongs your mental life and prevents ageing. We built Brain+ in the belief that people want to keep developing and challenging their mental capacity.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;We believe that to achieve the right amount of brain-training intensity and duration, you need to be engaged and immersed,&rdquo; he adds. &ldquo;We achieve this by designing our exercises more like traditional mobile games and less like clinical exercises, whereas our competition utilise a more traditional exercise approach.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br />Improve your mental abilities</strong></span><br /> <br /><span style="font-size: 10pt;"> Built on cutting-edge neuroscientific insights, methods and training principles that have been validated scientifically, the Brain+ platform&rsquo;s exercises deliver effective training for improving and protecting the brain&rsquo;s abilities, performance and health in children, young adults, older adults and people in need of rehabilitation and recovery from brain injury, disease and deficit recovery.</span><br /> <br /><span style="font-size: 10pt;"> For children, Brain+ takes advantage of their strong drive to play, learn and build abilities toward the development of a high-performing brain. With young adults, Brain+ boosts their day-to-day abilities and mental health to increase quality of life and performance at school or on the job.&nbsp; For older adults, Brain+ increases abilities in core cognitive functions to maintain mental health and forestall age-related deterioration. And for people with brain injury, disease or in need of deficit recovery and maintenance, Brain+ prioritises cognitive abilities to assist in either returning to a normal life or stabilising or even improving a range of deficits.</span><br /> <br /><span style="font-size: 10pt;"> According to a company release, Brain+ is designed to deliver better performance results than other entrants in the brain-training market, which lack strength in scientific foundation and effect, and are locked into sterile, non-motivating models of test exercises. Specifically, Baden-Kristensen says, earlier entrants in the space fail to motivate users over the long term by properly engaging and captivating them due to a lack of gamification best practices, which Brain+ employs in its games.</span><br /> <br /><span style="font-size: 10pt;"> Because Brain+ develops exercises that closely resemble state-of-the art mobile games, the production value, art quality and design requirements are all high, thereby paving the way for unique training experiences, mimicking the entertainment provided by traditional mobile games while maintaining an emphasis on strengthening brain functions.</span><br /> <br /><span style="font-size: 10pt;"> Baden-Kristensen said Brain+ has feedback from many users who say they can feel the app makes a demonstrable difference in their lives because it&rsquo;s fun, engaging, less of a chore to give their brains a workout and drives a desire to share the challenge of their brain exercises with friends and family members.&nbsp;</span></p> <p><span style="font-size: 10pt;">Brain+&nbsp;has invested heavily in the development of a science-based, machine-learning algorithm and technology that challenges the user dynamically and with high precision according to the skills of the individual. </span><br /> <br /><span style="font-size: 10pt;"> <strong>Recommended by Benjamin Sadock</strong></span><br /> <br /><span style="font-size: 10pt;"> &ldquo;The Brain+ project provides a unique and well-proven approach to improve brain function,&rdquo; says Benjamin Sadock, the Menas S Gregory professor of Psychiatry at the New York University School of Medicine. &ldquo;The programme combines new scientific knowledge about how the brain works with the latest advances in gaming techniques to train the brain to operate at its maximum capacity.</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;The use of characters, action, movement, music and immediate feedback allows brain fitness to occur in an environment that is both playful and entertaining. Brain+ will be of use to both healthy adults and those with memory problems who wish to improve their cognitive skills,&rdquo; Sadock says.&nbsp; &ldquo;This is an exciting programme that will continually motivate and stimulate the user to gain new skills and greater confidence in his or her intellectual life. I recommend it most highly.&rdquo;</span><br /> <br /><span style="font-size: 10pt;"> Brain+ has already demonstrated proof of concept by achieving rapid growth in parts of Europe, Asia, Africa and Australia.</span></p></div> electroCore&apos;s funding US$10 million oversubscribed by all parties 2014-07-02T11:52:00Z 2014-07-02T11:52:00Z <div id="ImageMain38" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction38" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>electroCore has announced that its successful funding initiative of US$40 million, announced in April last year, has been oversubscribed by US$10 million by all parties including Merck&rsquo;s Global healthcare Innovation fund and private equity groups Easton Capital and Core Ventures. The final tranche of US$15 million of the US$40 million was optional but following discussions between the investors this was not only made compulsory but increased by US$10 million to a total of US$50 million.</strong></span></p> </div><div id="Text138" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">electroCore has developed and patented a non-invasive vagus nerve stimulation (nVNS) therapy for the treatment of a variety of conditions in neurology, psychiatry, gastroenterology and other conditions.</span></p> <p><span style="font-size: 10pt;"><br />Its focus, at present, is primary headache - cluster and migraine - where it is just concluding four randomised studies in Europe and the USA. The European randomised PREVA study, for the prevention and acute treatment of chronic cluster headache, last week achieved statistical significance on its primary endpoint by reducing the number of cluster headache attacks per week by 47.5% in patients treated with nVNS compared to 12.1% in patients treated with the best available standard of care.</span></p> <p><span style="font-size: 10pt;"><br />In Europe, the nVNS technology, as delivered by electroCore&rsquo;s gammaCore device is considered CE markable, and a CE mark has been awarded in primary headache, bronchoconstruction, epilepsy, gastric motility disorders and depression and anxiety. In the US the pivotal trial for headache is just finishing and an application for a US license will follow.</span></p> <p><span style="font-size: 10pt;"><br />Surgically implanted vagus nerve stimulation (VNS) has been proven for more than twenty years, and in more than 100,000 patients, to be an effective and safe therapy for the treatment of refractory epilepsy and depression but because of its high cost and invasiveness it has been relegated to the end of the continuum of care.</span></p> <p><span style="font-size: 10pt;"><br />JP Errico chief executive officer and founder comments: &ldquo;It has been known for years that vagus nerve stimulation relieved a whole variety of conditions including headache, bronchoconstruction, and many other symptoms but because of its US$30,000 cost it was not considered. We believe that we have revolutionised this effective treatment by proving that our inexpensive nVNS therapy is just as effective as surgically implanted and can be used by millions of patients to self-treat their particular condition. Our nVNS therapy does one thing, it reduces the over expression of the excitatory neurotransmitter glutamate which has been implicated in a number of these disorders. This appears to be born out from the very encouraging signals we are getting from our clinical programme in headache as well as observational and open label studies across a number of these conditions.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />At the Royal Free Hospital in London the company is running a double-blind, parallel, sham controlled trial in patients with two of the most common gastrointestinal complaints; Irritable Bowel Syndrome and functional dyspepsia. This follows a successful proof of concept assessment in patients with gastroparesis. &nbsp; &nbsp;&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />electroCore is involved in clinical trials in universities across Europe and plans to extend this to the US after receiving FDA approval.</span></p></div> Agenus brain cancer vaccine shows extended survival in phase 2 final data analysis 2014-07-02T11:23:00Z 2014-07-02T11:23:00Z <div id="Introduction39" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Agenus&nbsp;has announced final results from a single-arm, multi-institutional, open-label, phase 2 study showing that patients with newly diagnosed glioblastoma multiforme (GBM) who received Agenus&rsquo; Prophage autologous cancer vaccine added to the standard of care treatment, lived nearly twice as long as expected.</strong></span></p> </div><div id="Text139" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In this phase 2 study, 50% of the patients lived for two years, an encouraging result for a cancer that often kills patients within one year. Prophage patients demonstrated a median overall survival of approximately 24 months and 33% of patients remain alive at two years and continue to be followed for survival.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These data suggest that Prophage is generating an effective immune response which is translating into an extension in survival far beyond what is historically seen in patients with glioblastoma multiforme. These data provide the impetus for a definitive, randomised clinical trial,&rdquo; says&nbsp;Andrew Parsa, principal investigator of the study and the Michael J Marchese professor and chair of the&nbsp;Department of Neurological Surgery&nbsp;at the Feinberg School of Medicine at Northwestern University. &ldquo;Glioblastoma tumours are often resistant to standard therapies and the extended progression-free survival and proportion of long-term survivors is very encouraging.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In addition to the long-term survival data, vaccine treated patients had a median progression-free survival (PFS) of nearly 18 months, approximately two to three-times longer than patients treated with radiation and temozolomide alone. Importantly, 22% of patients were alive and without progression at 24 months and continue to be followed for survival.</span></p> <p><br /><span style="font-size: 10pt;">Interestingly, the response to Prophage seems to be more pronounced in those patients with less expression of the checkpoint ligand PDL-1 on the white blood cells, suggesting that combinations of Prophage with checkpoint modulators like PD-1 antagonists might make Prophage even more effective in a greater percentage of patients with glioblastoma multiforme.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We believe that Prophage may play an important role in changing the treatment paradigm for patients with glioblastoma multiforme,&rdquo; says Garo Armen, chief executive officer and chairman of Agenus. &ldquo;We are exploring partnerships for phase 3 studies of Prophage in glioblastoma multiforme. Additionally, we are excited about the potential combinations of Prophage with PD-1 antagonists and other checkpoint modulators in glioblastoma multiforme.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Prophage is an autologous cancer vaccine, and each patient receives vaccine prepared from their own surgically resected tumour. As a result, the vaccine appears to help stimulate the patient&rsquo;s immune system to attack the tumour based on the spectrum of mutant proteins expressed by their own tumour. Since most cancers result from an accumulation of random mutations, which produce different mutant proteins in each patient, this approach is intended to individually tailor each patient&rsquo;s vaccine to optimally target the immune attack to that patient&rsquo;s actual tumour.</span></p></div> Scotland’s National Epilepsy Centre reports 100% success rate in first year 2014-07-02T11:13:00Z 2014-07-02T11:13:00Z <div id="Introduction40" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A new national centre of excellence for the treatment of epilepsy in Scotland, which integrates health care with social care, has recorded a 100% success rate in its first year.</strong></span></p> </div><div id="Text140" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The William Quarrier Scottish Epilepsy Centre (WQSEC), a not-for-profit partnership between charity Quarriers and the NHS, welcomed 96 patients in the 12 months after opening in April 2013, its first annual report has revealed.</span></p> <p><br /><span style="font-size: 10pt;">During 2013/14 the centre enjoyed a 100% success rate in transforming lives through accurate diagnosis, including being more accessible for people with disabilities (27% of patients).</span></p> <p><br /><span style="font-size: 10pt;">A devastating, sometimes fatal, neurological condition, it is expected more than 2,000 Scots will this year be told they have epilepsy. The WQSEC has capacity to accommodate up to 170 patients annually while over the lifetime of the building the centre will transform more than 10,000 lives and reduce deaths.</span></p> <p><br /><span style="font-size: 10pt;">The first anniversary of the WQSEC was marked with a special patient celebration event attended by around a third of those admitted to the centre during its first year.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Gerard Gahagan, head of Epilepsy Services at WQSEC, says: &ldquo;We are extremely proud of what has been achieved in our first year, with the voluntary sector and NHS working together so effectively to deliver a world-class centre of excellence.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;While patients benefit from clinical innovation, quality of care, and long-term improvements leading to better lives, health boards have experienced reduced waiting lists, a reduced drugs bill and less pressure on Accident &amp; Emergency, inpatient beds and outpatient clinics.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;What sets the WQSEC apart, however, is the ability to diagnose the most complex cases; those that are particularly severe, or where there are issues that complicate diagnosis such as disabilities or psychological problems. This ability has been taken to a new level with our new, world-leading Video Observation System diagnostic technology and the design features of the new building itself.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;These capabilities have attracted significant interest from European clinicians who consider the WQSEC to be a model they could replicate across the continent. The fact that Scotland hosts this centre of excellence is being noticed internationally and there are opportunities for research of international significance.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">He adds: &ldquo;For so many of our patients to return to join in a celebration is a demonstration of the centre&rsquo;s people-centred approach and strong patient participation and engagement.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The WQSEC is also improving knowledge and understanding of epilepsy, with more than 450 medical students now being trained at the centre throughout the year.&nbsp; The centre and its team has hosted an international conference &ndash; Challenging Epilepsy &ndash; attended by 100 practitioners, pioneered a research programme with the University of Glasgow and chaired the government&rsquo;s National Neurological Advisory Group Epilepsy team. It also has outreach services which help people across the country while epilepsy awareness days have been organised at for companies and public sector bodies.</span></p> <p><br /><span style="font-size: 10pt;">Importantly, another of WQSEC&rsquo;s key objectives has been met with a marked increase in admissions from outwith West of Scotland reflecting the national status. Since opening, patients being referred to the centre from other parts of Scotland now represent 39% of all admissions, compared with 30% last year and 25% the year before (to the previous facility).</span></p> <p><br /><span style="font-size: 10pt;">Reasons for referral are as follows:</span><br /><br /></p> <p><span style="font-size: 10pt;">&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; To clarify diagnosis &ndash; 68%</span></p> <p><span style="font-size: 10pt;">&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; To review medication &ndash; 13%</span></p> <p><span style="font-size: 10pt;">&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; To clarify seizures &ndash; 13%</span></p> <p><span style="font-size: 10pt;">&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; For video-telemetry only &ndash; 3%</span></p> <p><span style="font-size: 10pt;">&middot;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; To investigate sleep issues &ndash; 3%</span><br /><br /></p> <p><span style="font-size: 10pt;">Diagnoses found that 49% of patients had epilepsy, 27% had non-epileptic seizures while 24% had a complex mixture of both epileptic and non-epileptic seizures which can be very difficult to diagnose. With these diagnoses, the WQSEC is able to provide treatment tailored to each individual, improving seizure control, or reducing the powerful side-effects of drugs by rationalising medication. In every case, treatment radically increases quality of life, while in many cases, it is life-saving.</span></p> <p><br /><span style="font-size: 10pt;">Bill Scott, Patron of the Scottish Epilepsy Centre, says: &ldquo;Having finished the construction of the William Quarrier Scottish Epilepsy Centre, it could be tempting to sit back in satisfaction with a job well done. However, 54,000 Scots live daily with this cruel condition. Lives continue to be shattered by epilepsy and the social and economic cost is huge.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The WQSEC was conceived and designed to meet this crisis. With the completion of the WQSEC, Quarriers has not only the platform, but indeed an obligation to strive to improve outcomes for all people with epilepsy in Scotland.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;With its world-class facilities, European treatment and diagnostic leadership the WQSEC will certainly transform hundreds of lives each year. We will use this as a catalyst which, combined with policy influencing, research and training programmes, will contribute to the delivery of improved life-changing services to tens of thousands in Scotland and beyond.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In this way, the WQSEC is not the end of our ambition. In fact, it&rsquo;s just the beginning.&rdquo;</span></p></div> Omega-3 fats may significantly reduce damage from stroke 2014-07-02T10:54:00Z 2014-07-02T10:54:00Z <div id="ImageMain41" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction41" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>New evidence shows that the&nbsp;omega-3 polyunsaturated fatty acids (PUFAs) found in seafood and marine oils,&nbsp;DHA&nbsp;and&nbsp;EPA, can significantly reduce damage from stroke in a mouse model when given immediately afterwards. Moreover, DHA and another PUFA demonstrate a positive effect on neurocognitive function in children. These findings and more were presented 29-30 June at the 11<sup>th</sup>Congress of the&nbsp;International Society for the Study of Fatty Acids and Lipids&nbsp;(ISSFAL) in&nbsp;Stockholm, Sweden.</strong></span></p> </div><div id="Text141" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">About 15 million people worldwide have a stroke each year and risk increases with age. Ischaemic stroke, caused by a blockage of a blood vessel that supplies blood to the brain, accounts for about 87% of all cases. Investigators at&nbsp;Goethe University&nbsp;of&nbsp;Frankfurt, Germany, explored ischaemic stroke in mice and the impact of an EPA and DHA emulsion administered 90 minutes afterwards, by examining the degree of damage, cellular function and neuroinflammation.</span></p> <p><span style="font-size: 10pt;"><br />Treatment with the omega-3 emulsion significantly decreased the stroke area by 21% and lowered the severity of stroke by 50%. It also significantly improved brain cell function and reduced markers of inflammation.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This pilot study demonstrated that DHA and EPA might aid in early medical intervention in ischaemic stroke,&rdquo; says&nbsp;Gunter Eckert, associate professor of pharmacology and toxicology at Goethe. &ldquo;Further investigation is in order and holds promise for human trials.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />DHA&rsquo;s involvement in recovery from stroke was also explored by&nbsp;Nicolas Bazan, professor and director, Neuroscience Center of Excellence,&nbsp;Louisiana State University Health Sciences Center,&nbsp;New Orleans, USA. DHA encourages the production of special substances that allow for cell survival under excessive stress, neurodegeneration or ischaemic stroke.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These substances are increased by DHA after ischaemic stroke in animals, followed by remarkable neurological recovery,&rdquo; notes Bazan.</span></p> <p><span style="font-size: 10pt;"><br />The benefits of DHA in brain health have also been demonstrated in humans.&nbsp;Kathleen Gustafson, research assistant professor,&nbsp;University of Kansas Medical Center,&nbsp;Kansas City,&nbsp;USA, and colleagues investigated the effect of DHA and arachidonic acid (ARA), an omega-6 PUFA, on response inhibition in a follow-up study of 54 term infants randomised to receive formula with or without PUFAs from birth to 12 months. At roughly 5.5 years, children participated in a go/no-go task requiring rule learning and inhibitory control. Supplemented children responded more effectively and less impulsively.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Data from this trial have consistently demonstrated benefits of PUFA supplementation in visual, cardiac and cognitive function out to 6 years of age,&rdquo; says Gustafson. &ldquo;This suggests that supplementation with DHA and ARA has a programming effect in the brain during a critical period of development, which is long-lasting.&rdquo;</span></p></div> FDA clears Surgical Theater’s SNAP 2014-07-01T14:44:00Z 2014-07-01T14:44:00Z <div id="ImageMain42" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction42" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Surgical Theater has received US Food and Drug Administration (FDA) clearance on the recently launched Surgical Navigation Advanced Platform (SNAP). The SNAP integrates with operating room technology to provide advanced 3D capabilities and augmented reality, allowing surgeons to enhance their surgery performance and &ldquo;see what cannot be seen&rdquo;.</strong></span></p> </div><div id="Text142" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The SNAP is the second of the company&rsquo;s line of products combining flight simulation technology with advanced CT/MRI imaging for use in brain surgery to receive FDA clearance. It enables surgeons to perform a real-life &ldquo;fly through&rdquo; of a &ldquo;patient-specific&rdquo; surgery and receive unique virtual-reality guidance to determine the safest and most efficient pathway to remove cerebral tumours and treat vascular anomalies.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />With the SNAP, surgeons can execute their surgery plan while in the operating room utilising a patient&rsquo;s CT/MRI scans, allowing enhanced accuracy and efficiency. It provides the ability to rotate the image or make it semi-transparent in order to see behind arteries and other critical structures, something not possible until now, affording for accuracy to be sustained during complex procedures. Also, SNAP&rsquo;s augmented reality and simulation capabilities allow surgeons to analyse virtual &ldquo;what if&rdquo; scenarios before making the actual incision. This precision enables surgeons to gain clinical insight that was previously unavailable.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We have used the SNAP in the operating room in a handful of surgeries. The SNAP&rsquo;s realistic 3D imaging is one-of-a-kind and has been introduced as an integrated operating room device for the first time at our medical centre,&rdquo; says Warren R Selman, chairman, Department of Neurological Surgery, University Hospitals Case Medical Centre, USA.&nbsp; &ldquo;It is just like watching a football game when multiple cameras are located around the arena and an editor can freeze the image, rotate, zoom in, zoom out and see things that he could not otherwise see. In my recent surgeries, I was able to pause the navigation scene during the surgery to rotate the image and to verify that I removed the entire tumour and to make sure that I was within a safe distance from a vital artery while removing the tumour. With the SNAP connected to the operating room navigation platform, the operating room team coordination is enhanced, and we are utilising the best imaging technology tool to benefit our patients.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Surgical Theater&rsquo;s first product, the Surgical Rehearsal Platform (SRP), paved the way to the operating room by providing surgeons with a way to plan and rehearse their surgeries outside of the operating room. To-date it is estimated that the SRP has been utilised by surgeons wanting to pre-live their procedure more than 500 times. Now the SNAP will be utilised to take the pre-planned pathway into the operating room to be used during the surgical procedure thanks to its ability to integrate into operating room navigation equipment. In addition, the flight simulator technology used in the software permits remote connection of multiple platforms; participants anywhere in the world can simultaneously work together and practice the same case with real-time feedback and collaboration.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are extremely excited to expand our offerings beyond planning and rehearsing surgeries outside the operating room,&rdquo; says Moty Avisar, Surgical Theater chief executive officer and co-founder. &ldquo;The SNAP, our advanced imaging platform, allows us to connect to the operating room navigation system and become a part of the surgery as its performed, enabling a surgeon and operating room team to achieve their goal of delivering the best care and outcome for the patient. We are witnessing strong anticipation from the medical community about this new technology, with multiple pre-orders for the SNAP already placed from hospitals across the country.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Since Surgical Theater obtained FDA clearance on their first product in February 2013, SRPs have been installed in leading research and teaching hospitals across the United States. Hospitals include: University Hospitals Case Medical Center, University Hospitals Rainbow Babies and Children&rsquo;s Hospital, The Ronald Reagan UCLA Medical Center, The Mount Sinai Hospital, Mayo Clinic, NYU Langone Medical Center, and others.</span></p></div> Lemtrada approved in Argentina for treatment of multiple sclerosis 2014-07-01T14:28:00Z 2014-07-01T14:28:00Z <div id="ImageMain43" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction43" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Genzyme has announced that Argentina&rsquo;s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved Lemtrada&nbsp;(alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.</strong></span></p> </div><div id="Text143" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Lemtrada clinical trial data demonstrating the treatment&rsquo;s positive impact on relapse rates and disability progression support its potential as a transformational new treatment for relapsing-remitting multiple sclerosis,&rdquo; says Norma Deri, Hosptial Fernandez, Buenos Aires, Argentina. &ldquo;The approval of Lemtrada is good news for people living with active MS, who are in need of additional treatment options that may offer greater efficacy.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Lemtrada is supported by a comprehensive and extensive clinical development programme that involved nearly 1,500 patients and 5,400 patient-years of follow-up. In addition to Argentina, Lemtrada is approved in the European Union, Australia, Canada, Mexico, Brazil and Guatemala. Lemtrada is currently not approved in the United States. Genzyme recently announced that the US Food and Drug Administration (FDA) has accepted for review the company&rsquo;s resubmission of its application seeking approval of Lemtrada. Genzyme expects FDA action on the application in the fourth quarter.</span></p> <p><span style="font-size: 10pt;"><br />Lemtrada 12mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.<br /></span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are pleased by the continued global support for Lemtrada,"&nbsp;said Genzyme President and CEO, David Meeker.&nbsp;"We are launching the treatment in more than 30 countries this year, and look forward to additional approvals where Lemtrada is still under review.&rdquo;</span></p></div> AHA funds new research network aimed at preventing heart disease, stroke 2014-07-01T11:24:00Z 2014-07-01T11:24:00Z <div id="Introduction44" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The American Heart Association is funding a new research network to help people make behaviour changes to prevent heart disease and stroke, the two leading causes of death in the world.</strong></span></p> </div><div id="Text144" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Four institutions are banding together as the Strategically Focused Prevention Research Network Centers, funded by a US$15 million grant from the American Heart Association, which is designed to help people live longer, healthier lives.</span></p> <p><br /><span style="font-size: 10pt;">Obesity, high blood pressure and heart failure are among the study areas at the collaborative network, which is made up of investigators from Northwestern University in Chicago, Vanderbilt University in Nashville, the Icahn School of Medicine at Mount Sinai in New York and the University of Texas-Southwestern Medical School in Dallas, USA. The work will begin July 1.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Heart attack and stroke can strike suddenly, and frequently without warning. The best way to reduce premature death from cardiovascular diseases and stroke is to prevent the development of the risk factors that lead to these conditions,&rdquo; says American Heart Association president Elliott Antman, professor of medicine at Harvard Medical School and a senior physician in the Cardiovascular Division of the Brigham and Women&rsquo;s Hospital in Boston. &ldquo;Scientists working in these research centres are seeking to discover mechanisms that will allow all Americans to live healthier lives, and help lead us to a culture of health.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">A culture of health is an environment where the default choices people make are the healthy ones. For example, the air is smoke-free, nutritious foods are easy to find, safe places to exercise are abundant and quality healthcare is accessible.</span></p> <p><span style="font-size: 10pt;"><br />The culture of health concept is also important to the association&rsquo;s goal to improve the cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular diseases and stroke by 20% by 2020.</span></p> <p><span style="font-size: 10pt;">Getting America healthier means making headway in important areas like smoking, physical activity, diet, blood pressure, cholesterol and blood sugar. Northwestern Universitywill take a closer look at why heart-health measures decline from childhood to middle age and see if the latest techniques can help maintain ideal heart health and reverse declines. The goal is to learn how to implement behaviour change programmes on a large scale to benefit the most people.</span></p> <p><br /><span style="font-size: 10pt;">Two major hurdles &ndash; an overly salty, heart-hurting diet and the frequent need to take multiple, expensive medications &ndash; is spurring Vanderbilt University to develop new approaches for preventing high blood pressure. The goals are to understand how salt causes tissue injury, develop a method to detect and lower excess salt, and determine if a simple treatment in one pill can improve cardiovascular health.</span></p> <p><br /><span style="font-size: 10pt;">Nearly one-third of adults and children in the United States are obese, with rates even higher in Hispanic and African-American communities. The Icahn School of Medicine at Mount Sinai will aim to build a culture of health in Harlem, New York, USA with an urban-based health programme. Obesity is closely linked to heart disease, stroke, type 2 diabetes and certain types of cancer, among the leading causes of preventable death.</span></p> <p><br /><span style="font-size: 10pt;">Heart failure, when the heart cannot pump enough blood to the organs, is one of the most common reasons people 65 and older go into the hospital. Since there are no proven therapies to prevent heart failure with preserved ejection fraction, which affects about half of these patients, the University of Texas-Southwestern Medical School wants to shift the focus to prevention. The centre expects to find new interventions that can help heart failure patients in clinical settings.</span></p> <p><br /><span style="font-size: 10pt;">Each network centre will receive about US$3.8 million over the next four years.</span></p></div> China to build &apos;brain database&apos; 2014-07-01T10:47:00Z 2014-07-01T10:47:00Z <div id="Introduction45" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Chinese scientists are planning to build a &ldquo;brain database&rdquo; in a bid to identify clues to tackling cerebral diseases and related disorders.</strong></span></p> </div><div id="Text145" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The creation of a unified general and patient database will help us to identify the biomarkers of brain diseases, which we can then use as the basis for early diagnosis and treatment,&rdquo; says Poo Mu-ming, director of the Institute of Neuroscience under the Chinese Academy of Sciences.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;It will also be a useful resource for scientists around the world who are involved in brain research,&rdquo; he adds.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Though few details of the project have been made public, Poo says one of its primary goals will be to find treatments for conditions such as autism and Alzheimer&rsquo;s disease. Autism is a neurodevelopmental disorder whose incidence is on the rise globally. According to official figures, about one million Chinese children are affected by the condition. The World Health Organisation, however, said in 2008 that the country had 7.8 million autistic children. Meanwhile, 50% of the global population aged over 85 has Alzheimer&rsquo;s disease. By 2050, there could be as many as nine million seniors in China with the condition.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;There is currently no cure for Alzheimer&rsquo;s disease, but one of the goals of the brain database is to find ways to delay its onset,&rdquo; Poo says.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The announcement of the project was made yesterday at the Shanghai Science and Technology Museum, where scientists from the United States and Europe also gave details of their research projects in the field. Last year, European scientists launched the one billion euro (US$1.4 billion) &ldquo;Human Brain Project.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Its aim is to develop the infrastructure for neuroscience and related research that will help improve understanding of the human brain and its diseases, Kazinform has learnt from Xinhua.</span></p></div> Little or poor sleep may be associated with worse brain function when ageing 2014-06-30T16:31:00Z 2014-06-30T16:31:00Z <div id="Introduction46" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Research published in <a href="" target="_blank"><em>PLOS ONE</em></a> by researchers at the University of Warwick, UK indicates that sleep problems are associated with worse memory and executive function in older people.</strong></span></p> </div><div id="Text146" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Analysis of sleep and cognitive (brain function) data from 3,968 men and 4,821 women who took part in the English Longitudinal Study of Ageing (ELSA), was conducted in a study funded by the Economic and Social Research Council (ESRC). Respondents reported on the quality and quantity of sleep over the period of a month.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study showed that there is an association between both quality and duration of sleep and brain function which changes with age.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In adults aged between 50 and 64 years of age, short sleep (8hrs per night) were associated with lower brain function scores. By contrast, in older adults (65-89 years) lower brain function scores were only observed in long sleepers.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Michelle A Miller says, &ldquo;Six to eight hours of sleep per night is particularly important for optimum brain function, in younger adults. These results are consistent with our previous research, which showed that six to eight hours of sleep per night was optimal for physical health, including lowest risk of developing obesity, hypertension, diabetes, heart disease and stroke.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Interestingly, in the younger pre-retirement aged adults, sleep quality did not have any significant association with brain function scores, whereas in the older adults (&gt;65 years), there was a significant relationship between sleep quality and the observed scores.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Sleep is important for good health and mental wellbeing,&rdquo; says Francesco Cappuccio. &ldquo;Optimising sleep at an older age may help to delay the decline in brain function seen with age, or indeed may slow or prevent the rapid decline that leads to dementia.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Miller concludes that &ldquo;if poor sleep is causative of future cognitive decline, non-pharmacological improvements in sleep may provide an alternative low-cost and more accessible Public Health intervention, to delay or slow the rate of cognitive decline&rdquo;.</span></p></div> Philips and announce a strategic alliance 2014-06-30T14:52:00Z 2014-06-30T14:52:00Z <div id="Introduction47" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Royal Philips and have announced a strategic alliance to deliver an open, cloud-based healthcare platform, leveraging Philips&rsquo; leading positions in medical technology, clinical applications and clinical informatics and;s leadership in enterprise cloud computing, innovation and customer engagement. Patient relationship management will be at the centre of the envisioned platform, allowing caregivers to collaborate closely in support of their patients. The platform will enable medical device and data interoperability &ndash;&nbsp; the collection of data and subsequent analysis to enhance clinical decision making by professionals and enabling patients to take a more active role in managing their personal health.</strong></span></p> </div><div id="Text147" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The collaboration has already resulted in two clinical applications to be launched on the new platform later this summer: &ldquo;Philips eCareCoordinator&rdquo; and &ldquo;Philips eCareCompanion.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />These care collaboration applications will allow the care team to monitor patients with chronic conditions in their homes and will facilitate Philips&rsquo; Hospital to Home clinical programmes, such as Banner iCare, being piloted at Banner Health, a pioneer accountable care organisation in Arizona, USA. Similar telehealth-based care delivery models for hospitals utilising the Philips eICU programme were shown to reduce mortality by 26% and length of stay by 20% in a recent large, multicentre study.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;With this strategic alliance, Philips is making great strides to deliver real-time, digital healthcare solutions,&rdquo; says Frans van Houten, chief executive officer of Royal Philips. &ldquo;Healthcare data exists in many different forms and in many different systems today. Together with, we have a tremendous opportunity to reshape and optimise the way healthcare is delivered and provide better access to data across the continuum of care.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We have entered a new transformative era for healthcare and technology is enabling the industry to connect to, care for and engage with patients and each other in a profound new way,&rdquo; says Marc Benioff, chairman and chief executive officer, &ldquo;Together with Philips, we are creating an open health platform and ecosystem to benefit everyone that cares about one of the most important issues of our time.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Philips and envision that apps will cover the continuum of care: from self-care and prevention, to diagnosis and treatment through recovery and wellness. The envisioned platform, based on the Salesforce1 Platform, will enable collaboration and workflow, as well as integration of data from multiple sources worldwide, including electronic medical records, diagnostic and treatment information obtained through Philips&rsquo; imaging equipment, monitoring equipment, personal devices and technologies like Apple&rsquo;s HealthKit. Moreover, the cloud-based platform is designed to be highly scalable with built-in privacy and data security. By combining the data, the platform will allow for analysis that will enhance decision making by professionals and engage patients. Both Philips and foresee that the platform, will utilise Philips&rsquo; clinical data stores and medical device interoperability. It is intended to be open to developers and is expected to result in a vibrant ecosystem of partners creating applications. As a result, the envisioned platform has the potential to transform both professional healthcare delivery and continuous personal health management.</span></p></div> Lemtrada (alemtuzumab) 12mg IV, shortlisted for the 2014 Prix Galien Innovative Product Award 2014-06-27T17:06:00Z 2014-06-27T17:06:00Z <div id="ImageMain48" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction48" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Genzyme, a Sanofi company, has announced that it has been shortlisted for a Prix Galien award, in the Innovative Drug Award Category, for its multiple sclerosis therapy Lemtrada. A Prix Galien award is widely regarded as the highest distinction to be bestowed upon a pharmaceutical product. In recent years, the Prix Galien &lsquo;stamp&rsquo; has become synonymous with new treatment options that add significant value to health systems and improve outcomes for patients.</strong></span></p> </div><div id="Text148" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The award nomination reinforces Lemtrada&rsquo;s status as an innovative new therapy option for people with relapsing-remitting multiple sclerosis (RRMS). The development of Lemtrada, led by UK scientists at Cambridge University with the support of Genzyme, demonstrates the high calibre of scientific ingenuity which is needed when developing additional treatment options for patients &ndash; and is a key characteristic of the UK&rsquo;s world renowned research and development industry, which Genzyme is proud to support and be part of.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The shortlisting of Lemtrada in the innovative drug category at these prestigious awards is testament to the pioneering research at Cambridge University and the collaboration with Genzyme to bring this new treatment option for people with relapsing-remitting multiple sclerosis.&nbsp; For people living with multiple sclerosis Lemtrada could really reshape the management of their condition and demonstrates Genzyme&rsquo;s focus on putting patients at the heart of everything we do,&rdquo; comments Brendan Martin, general manager for Genzyme UK and Ireland.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The submission for Lemtrada for the Prix Galien award focused on the drug&rsquo;s pivotal efficacy and safety data from the CARE-MS trials (Comparison of alemtuzumab and rebif efficacy in multiple sclerosis). The results of these trials were published in <a href="" target="_blank"><em>The Lancet</em></a>.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Having been involved with the clinical development of Lemtrada for more than 20 years, I am delighted that the innovative concept of lymphocyte depletion and reconstitution, and the evidence for efficacy in relapsing-remitting multiple sclerosis, are recognised by shortlisting for this important award. The research community in Cambridge is proud of our focus on improving outcomes for people with neurological disease through clinical application of pioneering basic science,&rdquo; says Alastair Compston, professor of neurology and head of the Department of Clinical Neurosciences, University of Cambridge.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The 2014 UK Prix Galien awards ceremony will take place on Wednesday 1st October at the House of Commons, London, where the winners of the awards will be announced. The Rt. Hon. Sir Kevin Barron, MP &ndash; former chair of the Health Select Committee and chair of several all-party Parliamentary groups relating to the pharmaceutical industry and health &ndash; will be the Parliamentary sponsor for the awards this year. Genzyme has previously won a UK Prix Galien Gold Medal for Myozyme in 2006.</span></p></div> New device allows brain to bypass spinal cord and move paralysed limbs 2014-06-27T16:27:00Z 2014-06-27T16:27:00Z <div id="ImageMain49" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction49" style="clear:both;"> <p><strong><span style="font-size: 11pt;">For the first time ever, a paralysed man has moved his fingers and hand with his own thoughts after an electronic neural bypass for spinal cord injuries that reconnects the brain directly to muscles, allowing voluntary and functional control of a paralysed limb. This innovation comes from a partnership between The Ohio State University Wexner Medical Center and Battelle.</span></strong></p> </div><div id="Text149" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Ian Burkhart, a 23-year-old quadriplegic from Dublin, USA, is the first patient to use Neurobridge, an electronic neural bypass. Burkhart is the first of a potential five participants in a clinical study.</span><br /><br /><span style="font-size: 10pt;">&ldquo;It is much like a heart bypass, but instead of bypassing blood, we are bypassing electrical signals,&rdquo; said Chad Bouton, research leader at Battelle. &ldquo;We are taking those signals from the brain, going around the injury and going directly to the muscles.&rdquo;</span><br /><br /><span style="font-size: 10pt;">The Neurobridge technology combines algorithms that learn and decode the user&rsquo;s brain activity and a high-definition muscle stimulation sleeve that translates neural impulses from the brain and transmits new signals to the paralysed limb. In this case, Burkhart&rsquo;s brain signals bypass his injured spinal cord and move his hand.</span><br /><br /><span style="font-size: 10pt;">The project investigating the Neurobridge was a six-month, Food and Drug Administration (FDA)-approved clinical trial at Ohio State&rsquo;s Wexner Medical Center.</span><br /><br /><span style="font-size: 10pt;">Working on the internally-funded project for nearly a decade to develop the algorithms, software and stimulation sleeve, Battelle scientists first recorded neural impulses from an electrode array implanted in a paralysed person&rsquo;s brain. They used the data to illustrate the device&rsquo;s effect on the patient and prove the concept.</span><br /><br /><span style="font-size: 10pt;">Two years ago, Bouton and his team began collaborating with Ohio State neuroscience researchers and clinicians Ali Rezai and Jerry Mysiw to design the clinical trials and validate the feasibility of using the Neurobridge technology in patients.</span><br /><br /><span style="font-size: 10pt;">During a three-hour surgery on 22 April, Rezai implanted a chip onto the motor cortex of Burkhart&rsquo;s brain. The tiny chip interprets brain signals and sends them to a computer, which recodes and sends them to the high-definition electrode stimulation sleeve that stimulates the proper muscles to execute his desired movements. Within a tenth of a second, Burkhart&rsquo;s thoughts are translated into action.</span></p></div><div id="Text249" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The surgery required the precise implantation of the micro-chip sensor in the area of Burkhart&rsquo;s brain that controls his arm and hand movements,&rdquo; Rezai says.</span><br /><br /><span style="font-size: 10pt;">He said this technology may one day help patients affected by various brain and spinal cord injuries such as strokes and traumatic brain injury.</span></p> <p><span style="font-size: 10pt;">Battelle also developed a non-invasive neurostimulation technology in the form of a wearable sleeve that allows for precise activation of small muscle segments in the arm to enable individual finger movement, along with software that forms a &lsquo;virtual spinal cord&rsquo; to allow for coordination of dynamic hand and wrist movements.</span><br /><br /><span style="font-size: 10pt;">The Ohio State and Battelle teams worked together to investigate the correct sequence of electrodes to stimulate and allow Burkhart to move his fingers and hand functionally. For example, Burkhart uses different brain signals and muscles to rotate his hand, make a fist or pinch his fingers together to grasp an object, Mysiw explains. As part of the study, Burkhart worked for months using the electrode sleeve to stimulate his forearm to rebuild his atrophied muscles so they would be more responsive to the electric stimulation.</span><br /><br /><span style="font-size: 10pt;">&ldquo;I have been doing rehabilitation for many years, and this is a tremendous stride forward in what we can offer these people,&rdquo; said Mysiw, chair of the Department of Physical Medicine and Rehabilitation at Ohio State. &ldquo;Now we are examining human-machine interfaces and interactions, and how that type of technology can help.&rdquo; &nbsp;</span></p></div> Covidien announces European launch of Pipeline Flex embolisation device 2014-06-27T14:14:00Z 2014-06-27T14:14:00Z <div id="ImageMain50" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction50" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Covidien announced the European launch of its Pipeline Flex embolisation device at the annual Live Interventional Neuroradiology and Neurosurgery Course (LINNC, 23&ndash;25 June, Paris, France). This next-generation flow diversion device received CE mark earlier this year.</span></strong></p> </div><div id="Text150" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Designed to divert blood flow away from an aneurysm, the Pipeline Flex device features a braided cylindrical mesh tube that is implanted across the base or neck of the aneurysm. The device cuts off blood flow to the aneurysm, reconstructing the diseased section of the parent vessel. The device is repositionable and designed for even more accuracy and controlled placement. Among other features, it includes an instant braid release system that makes it even easier to place, a press release from the company states.</span><br /><br /><span style="font-size: 10pt;">&ldquo;The Pipeline Flex embolisation device is the next advancement in flow diversion, combining our clinically-proven braid design with a new delivery system designed to offer even more accuracy and control when performing these advanced procedures inside the brain,&rdquo; said Brett Wall, president, Neurovascular, Covidien.</span><br /><br /><span style="font-size: 10pt;">In Europe, the Pipeline Flex device is intended for the endovascular embolisation of cerebral aneurysms. The first-generation Pipeline embolisation device has been used to treat patients in Europe since 2009. It has been the only flow diversion device commercially available in the USA since it was approved by the US Food and Drug Administration in April 2011. The Pipeline Flex device is not currently approved for use in the USA.</span></p></div> New Neuro-Oncology chair for Ohio Clinical Trials Collaborative 2014-06-27T11:32:00Z 2014-06-27T11:32:00Z <div id="ImageMain51" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction51" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Ohio Clinical Trials Collaborative (OCTC) has appointed Jill Barnholtz-Sloan as chair of its Neuro-Oncology Working Group. Barnholtz-Sloan is an associate professor at Case Western Reserve University School of Medicine, associate director for Clinical Informatics, Institute for Computational Biology and a member of the Case Comprehensive Cancer Centre.</strong></span></p> </div><div id="Text151" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Because Ohio is uniquely positioned as a stronghold of individual brain tumour investigators, novel neuro-oncology, basic science and clinical research, the OCTC has a world-class interdisciplinary team with the ability to study the genetic changes responsible for the onset, spread and recurrence of brain tumours,&rdquo; says Barnholtz-Sloan.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The OCTC will establish Ohio as one of the most efficient and effective states in which to develop new medicines and treatment strategies,&rdquo; James Chmiel, chief executive and director of the OCTC says. &ldquo;The development of new treatments for brain tumours is critical because patient survival has not improved substantially in 30 years.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The OCTC provides centralised access to Ohio&rsquo;s premier medical centres for clinical trial development. The pharmaceutical industry faces a challenging and expensive process for conduct of clinical trials. The OCTC streamlines the contracting, budgeting, approval of human subject use and patient recruitment/enrolment processes so medical discoveries can move to market faster.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;I am enthusiastic about leading this extraordinary statewide team to advance clinical trials in neuro-oncology and achieve our goal of developing new treatments for brain tumour patients,&rdquo; says Barnholtz-Sloan.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The adult component of this working group will be co-chaired by David Peereboom, professor of medicine at Cleveland Clinic Lerner College of Medicine and director, Clinical Research at The Rose Ella Burkhardt Brain Tumour &amp; Neuro-Oncology Centre and the paediatric component of this working group will be co-chaired by Jonathan Finlay, professor and director of Paediatric Neuro-Oncology at Nationwide Children&rsquo;s Hospital.</span></p></div> Pilot study shows gammaCore for the prevention of migraine is safe and reduces number of headache days 2014-06-27T09:46:00Z 2014-06-27T09:46:00Z <div id="ImageMain52" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction52" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Two poster presentations at the American Headache Society (AHS) meeting in California, USA, reported the results of the sham controlled pilot study that examined the use of electroCore&rsquo;s non-invasive vagus nerve stimulation therapy (nVNS) to prevent chronic migraine. The study met its endpoint of safety, and also demonstrated a reduction in the number of headache days per month for patients using the active device. The study further suggests that patients who remained on therapy for longer periods of time, may enjoy progressively larger decreases in headache days over the period they are on therapy.</strong></span></p> </div><div id="Text152" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Stephen Silberstein, professor of neurology at the Jefferson Medical College and director of the Jefferson Headache Centre comments: &ldquo;In this pilot study we showed that nVNS was able to demonstrate an increasingly meaningful decrease in headache days in those patients who were treated with nVNS for a number of months. Our trial suggests that nVNS is a safe and effective alternative to drug therapies. I look forward to participating in larger studies in migraine to further confirm and expand on these findings.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study which ran over nine months at six sites across the US comprised a run-in period of one month, a double-blind comparison period of two months, and an open-label phase of six months during which all patients used electroCore&rsquo;s gammaCore device on daily basis to reduce the occurrence of their chronic migraines. The 59 adult migraine patients who were enrolled in the study had to have had more than 15 headache days per month in the three months preceding the trial, in accordance with the ICHD definition of Chronic Migraine.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />During the comparative period, the patients were randomised and given either an active gammaCore device or a sham device that appeared identical but did not stimulate the vagus nerve. Neither the patient, nor the physician, nor the clinical trial monitors were aware of which device each patient was given. The patients self-administered the treatment by placing the gammaCore device on the right sides of their necks, over their vagus nerves, three times daily. Each treatment consisted of two 90-second stimulations, five to ten minutes apart.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In the two month comparative phase, there was a decrease of 1.9 headache days per 28 days with three nVNS treated patients having more than a 50% decrease, and one having a 75% decrease in headache days. No sham control patients achieved a significant reduction. During the open label phase, the drop in headache days continued to grow, with patients originally randomised to the active therapy and remaining on therapy through the full six-month open label phase, experiencing more than an eight day drop in headache days per month. Among the entire group of patients remaining on therapy for the defined six months, 38% experienced a 50% reduction in headache days per month.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />JP Errico founder and chief executive officer of electroCore comments, &ldquo;We continue to be pleased by the clinical studies that consistently demonstrate nVNS therapy to be a safe, easy to use, preventative treatment that reduces the burden of severe headache for many patients. Although only a pilot study, these results confirms our intention to continue with larger scale studies in the prevention of migraine. We look forward to the full presentation of this data, and are continuing to explore the efficacy of nVNS in a range of related diseases and disorders.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Data from all the 59 patients are included in the safety study. Twenty-six patients from the nVNS arm and 23 from the sham control arm completed the two-month comparative phase. No serious adverse events were reported.</span></p></div> Lingraphica introduces iPad app to help survivors of stroke and traumatic brain injury recover language skills 2014-06-25T12:31:00Z 2014-06-25T12:31:00Z <div id="Introduction53" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Lingraphica has introduced the iPad app component of TalkPath Therapy, its integrated cloud-based speech therapy solution for the millions of adults with aphasia, a speech disorder that affects the ability to speak, write or comprehend language, and the clinicians who work with them to improve language skills. The company, which has researched and produced rehabilitative speech-generating devices and assistive technology for adults with aphasia since 1990, is offering the subscription-based solution, available on the iPad and the Web, for free during its extended trial period.</strong></span></p> </div><div id="Text153" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">TalkPath Therapy for the iPad has been named best mobile commerce app in the 2014 New Jersey Technology Council&rsquo;s Mobile Apps Forum competition, which fielded entries from companies based in multiple states and several countries.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />With one account users can access more than 4,600 scientifically designed speech therapy exercises online or offline from the iPad and online from a Web browser.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />TalkPath Therapy was designed under the guidance of a team of speech-language pathologists and the company conducted significant usability testing with members of its Lingraphica Aphasia Users&rsquo; Group &ndash; each of whom is working to rebuild speech lost because of stroke. The company&rsquo;s own research shows that with continued practice using TalkPath Therapy&rsquo;s proprietary icons and content, users can recover language lost to due to a stroke or other brain injury.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;TalkPath Therapy is a truly mobile speech therapy solution that meets the needs of individuals with aphasia and their clinicians,&rdquo; says Andrew Gomory, chief executive officer of Lingraphica. &ldquo;We used our three decades of experience to transform our offerings into an even more meaningful and effective rehabilitative solution.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Clinicians using TalkPath Therapy have access to extensive reporting features including task-based reports and detailed activity reports. These features make it easy to show improvement and adjust plans in real time. No other solution on the market allows for this functionality on multiple platforms.</span></p></div> Imperial College London initiates study to investigate genetics of Parkinson’s disease 2014-06-25T11:41:00Z 2014-06-25T11:41:00Z <div id="Introduction54" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at the Imperial College London will study individuals with genetic mutations associated with Parkinson&rsquo;s disease as one of 32 clinical sites of the Parkinson&rsquo;s Progression Markers Initiative (PPMI), a large-scale biomarker study sponsored by The Michael J Fox Foundation for Parkinson&rsquo;s Research. The study is seeking volunteers of Ashkenazi Jewish background to participate.</strong></span></p> </div><div id="Text154" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Overall, PPMI will enrol participants with a known mutation of the LRRK or SNCA [alpha-synuclein] gene. At Imperial College London, the researchers will look specifically at the LRRK2 mutation. Previous research has shown that both mutations are associated with Parkinson&rsquo;s disease, and account for a greater number of Parkinson&rsquo;s disease cases among certain ethnic populations and families, notably the LRRK2 mutation in those of Ashkenazi (Eastern European) Jewish, Basque and North African Berber descent. The insight gleaned from these research volunteers will fortify current efforts to develop a disease-modifying therapy, something that currently eludes the field.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Studying individuals with genetic mutations associated with Parkinson&rsquo;s can accelerate our research toward a Parkinson&rsquo;s disease biomarker and more effective treatments,&rdquo; says Nicola Pavese, the co-principal investigator of the PPMI study at Imperial College London. &ldquo;Although known genetic mutations currently account for only 5 to 10% of all Parkinson&rsquo;s cases, this population can provide invaluable information about the intricacies of the disease for all patients.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />PPMI is studying clinical and imaging data and biological samples of people with a genetic mutation to identify biomarkers and speed clinical trials. PPMI will enrol 250 people with the LRRK2 mutation and Parkinson&rsquo;s and 250 people with the mutation but without Parkinson&rsquo;s. Since the SNCA mutation is rarer, the study is recruiting 50 people with Parkinson&rsquo;s and the mutation and 50 people with the SNCA mutation but without Parkinson&rsquo;s disease. These participants will be followed for five years.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Launched in 2010, PPMI is a longitudinal clinical study that collects standardized clinical, imaging and biologic data. Now taking place at 32 clinical sites around the world, the study completed initial enrollment of 423 recently diagnosed Parkinson&rsquo;s patients and 196 controls in April 2013. That month PPMI began recruiting individuals with the known Parkinson&rsquo;s risk factors of smell loss and REM sleep behavior disorder.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;In the fourth year of PPMI, it is evident that a large-scale biomarker study is not only possible in Parkinson&rsquo;s disease, but is already yielding scientific insights that could help transform the field of Parkinson&rsquo;s research,&rdquo; says Todd Sherer, chief executive officer of The Michael J Fox Foundation. &ldquo;The exceptional investigators at sites around the world, such as at Imperial College London, have created the infrastructure that allows us to make such strides, by working together.&rdquo;</span></p></div> Neuralstem&apos;s NSI-189 novel neurogenic compound shows significant effect in major depressive disorder 2014-06-25T11:14:00Z 2014-06-25T11:14:00Z <div id="Introduction55" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neuralstem has announced that two sets of data from the NSI-189 clinical trial in major depressive disorder (MDD) were reported at two recent academic conferences: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, and the International College of Neuropyschopharmacology (CINP) Annual Meeting. NSI-189 is Neuralstem&rsquo;s lead proprietary neurogenic compound.</strong></span></p> </div><div id="Text155" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">At the CINP meeting, a poster presentation on quantitative EEG (qEEG) measurements, an electrophysical biomarker of depression, taken during the course of study showed that patients in the active treatment arm of the study:<br /><br /></span></p> <ul> <li><span style="font-size: 10pt;">Had significantly increased brain wave patterns in the hippocampal region of the brain. Specifically, qEEG measurements at day 28 showed statistical significance between the treatment and the placebo group in the electrical wave patterns emanating from specific areas of the brain, namely the left posterior temporal lobe and parietal region (p&lt;0.02).</span></li> <li><span style="font-size: 10pt;">Showed increased electrical coherence in the prefrontal cortical region, which is a pro-cognitive signal.<br /><br /></span></li> </ul> <p><span style="font-size: 10pt;">Researchers concluded that these electrophysiological changes are consistent with the neurogenic hypothesis of the drug mechanism, which involves long-term structural changes in the hippocampus.<br /><br /></span></p> <p><span style="font-size: 10pt;">These results follow the 28-day clinical data presented at the ASCP meeting, which showed a significant and large treatment effect in the improvement of both depression and cognitive symptoms in the active therapy patients, compared to placebo, which continued eight weeks after treatment stopped, specifically:<br /><br /></span></p> <ul> <li><span style="font-size: 10pt;">In a comprehensive assessment scale for depression (Symptoms of Depression Questionnaire or SDQ), the combined treatment group showed statistically significant improvement (p=0.02) after 28 days of the drug treatment compared to its randomised, double-blinded, placebo control group.&nbsp; There was a large effect size of 0.90.</span></li> <li><span style="font-size: 10pt;">As measured by the assessment scale of cognitive and functioning deficits specifically designed for depressed patients (Cognitive and Physical Functioning Questionnaire or CPFQ), the treatment group was significantly better than the placebo group (p=0.01) at day 28 with a large effect size of 0.94.</span></li> <li><span style="font-size: 10pt;">As measured by both by SDQ and CPFQ, NSI-189&rsquo;s significant and large treatment effects continued for eight weeks even after the drug was withdrawn.<br /><br /></span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;This is a small study, but we should acknowledge the importance of showing such a powerful signal in such a small study in an indication with a very high placebo effect, historically,&rdquo; says Richard Garr, Neuralstem&rsquo;s president and chief executive officer.&nbsp; &ldquo;Additionally, we believe that no approved antidepressants have shown this type of long-term disease modifying property. If these large effect sizes and stable improvements in both depression and cognition are replicated with larger cohorts, we will pursue a breakthrough designation, with accelerated development prospects and reimbursement advantages. We plan to launch a large, multi-site phase II study by the first quarter of 2015.&rdquo;<br /><br /></span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&ldquo;We believe this qEEG data confirms that NSI-189 is affecting key circuitry common in both mood control and cognition, involving hippocampal neurogenesis and synaptogenesis,&rdquo; says Karl Johe, Neuralstem&rsquo;s chairman and chief scientific officer. &ldquo;The next clinical trial will test two doses (40mg QD and 40mg BID), along with a randomised, double-blinded, placebo control group, in approximately 150 patients with confirmed diagnosis of recurrent MDD, with the aim of confirming these extremely promising results in a larger clinical setting.&rdquo;</span></p></div> Neuro Resource Group’s hospital presence continues to expand 2014-06-24T12:40:00Z 2014-06-24T12:40:00Z <div id="Introduction56" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neuro Resource Group continues to expand the utilisation of its new InterX 900 ISSDE Pain Management System for post-surgical pain management in hospitals and surgery centres.</strong></span></p> </div><div id="Text156" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The InterX System, which consists of the InterX 900 Driver and InterX Sterile Self-Adhesive Dual Electrode, (ISSDE,) provides non-drug, non-invasive neurostimulation pain relief. Scientific research has shown that InterX produces a significantly greater physiological response than a standard neurostimulation device. The unique product design and waveform of InterX allows more focused, higher amplitude stimulation thus providing a reliable and consistent pain management solution for a broad range of patient conditions. </span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Utilisation of the InterX 900 ISSDE System in our initial hospital use continues to clinically validate the effectiveness of the technology and its ability to reduce the need of narcotic drugs for pain control following surgery. Hospitals using the system have reported that patients are experiencing improved pain management and reduced rehabilitation times, thus enabling an earlier release from the hospital,&rdquo; states Dave Turner, NRG&rsquo;s chief executive officer.</span></p></div> New Philips NeuroSuite reveals the brain’s vascular network like never before 2014-06-23T17:29:00Z 2014-06-23T17:29:00Z <div id="ImageMain57" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction57" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Royal Philips has announced the introduction of NeuroSuite, a new integrated solution designed to support and enhance minimally invasive image-guided neurological interventions. Philips&rsquo; new interventional X-ray solution offers more effective device guidance and placement in every neuroradiology procedure.</strong></span></p> </div><div id="Text157" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The first NeuroSuite system was recently installed at Karolinska University Hospital, Stockholm, Sweden. This hospital is one of the world&acute;s leading medical universities and a centre of excellence for stroke treatment.</span></p> <p><span style="font-size: 10pt;"><br />Neuroradiology is a branch of radiology that involves the diagnosis and minimally invasive treatment of the brain, head, neck and spine. These treatments require the insertion of a catheter, which must be navigated through a very narrow (with vessels less than 2mm wide) and tortuous vasculature to the treatment site with the aid of live image guidance. New devices (eg. stents and flow diverters) offer new treatments for ischaemic stroke or large neck aneurism, but their increasingly smaller designs make the devices more difficult to see with X-ray imaging. This can present additional challenges for placement and treatment assessment.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />To cope with these challenges Philips&rsquo; NeuroSuite consists of a bi-plane interventional X-ray system with a unique combination of two new detectors: Philips&rsquo; frontal FD20 detector delivers live 2D and 3D imaging to provide live navigation and immediate therapy feedback. The smaller, lateral FD15 detector can be positioned beyond the shoulders and very close to the head. This shorter distance and unique combination of detectors provides sharp, full brain imaging at lower X-ray dose and 3D imaging optimised for neuro and spine interventions.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;In image-guided interventions the ultimate goal is to see clearly and navigate effectively, while managing X-ray dose for patients, staff and clinicians,&rdquo; says Ronald Tabaksblat, general manager Interventional X-ray at Philips Healthcare. &ldquo;Developed in collaboration with clinical partners around the world, Philips NeuroSuite has been designed for that purpose and underpins Philips&rsquo; global leadership position in live-image guidance technologies.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br /><br />&ldquo;In interventional neuroradiology the performance of the angiographic system is crucial to patient safety,&rdquo; says Michael S&ouml;derman, associate professor and chief of Neuroangiography and Stereotaxy, Department of Neuroradiology, Karolinska University Hospital. &ldquo;Philips&rsquo; latest innovation is NeuroSuite with a new 20 inch detector on the frontal plane, providing superb 3D-images and big enough for spine imaging. On the lateral plane, the new 15 inch detector brings visualization of the complete cerebral vasculature, with reduced collision risks and enhanced projection freedom.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />At the heart of NeuroSuite is Philips AlluraClarity, lowering radiation dose by as much as 73% without compromising image quality: and VasoCT that visualises intracranial devices in vessel context and vessel morphology down to perforator vessels.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Over the last years a lot of progress was made on high resolution device visualisation,&rdquo; says Jacques Moret of the faculty of medicine Bichat-Beaujon at the University of Paris, France. &ldquo;The next step in our collaboration with Philips is the NeuroSuite bringing enhanced vessel and device visualisation and full head coverage. The new detector combination could be especially useful for stroke treatment.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Philips NeuroSuite will be officially launched at the Live Interventional Neuroradiology &amp; Neurosurgery Course (LINNC) in Paris from 23-25 June 2014.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />NeuroSuite is currently not available in the USA.</span></p></div> Gold for Airo Mobile Intraoperative CT in 2014 Medical Design Excellence Awards 2014-06-20T16:57:00Z 2014-06-20T16:57:00Z <div id="ImageMain58" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction58" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Airo&nbsp;Mobile Intraoperative CT, developed and manufactured by Mobius Imaging and distributed by Brainlab, was awarded gold in the Radiological and Electromechanical Device category of the 17</span><span style="font-size: 12px;">th</span><span style="font-size: 11pt;">&nbsp;Annual&nbsp;Medical Design Excellence Awards (MDEA) competition. Award winners were announced on June 11, 2014 at&nbsp;MD&amp;M East&rsquo;s&nbsp;main networking event&mdash;the&nbsp;2014 Medical Design Excellence Awards&nbsp;ceremony held in New York. This distinction comes just months after Airo was honoured with a 2014 Red Dot Product Design Award.</span></strong></p> </div><div id="Text158" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The&nbsp;2014 MDEA Juror Panel&nbsp;selected 33 winning products from among 54 exceptional finalist products in 11 medical technology product categories. Selected products excel in five areas: manufacturing and technological innovation; design and engineering advancements; patient benefits; business benefits; and overall improvement to healthcare industry.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We are proud and honoured to receive MDEA gold for Airo,&rdquo; says Gene Gregerson, chief executive officer Mobius Imaging. &ldquo;This recognition validates the work we have put into this exceptional product. By answering true clinical needs with this product, we help ensure that it can be intuitively incorporated into everyday clinical practice. The system&rsquo;s flexibility and mobility make Airo a valuable extension for several environments and a range of surgical clinical applications. We even worked directly with operating personnel including surgeons, anaesthetists and nurses to help verify numerous surgical workflows.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Created to operate inside existing operating room suites, Airo design boasts an ultra-small footprint which incorporates advanced CT technology for intraoperative imaging as well as custom-built components to help address various challenges of mobility and sterility within the operating room. With the largest gantry opening on the market, Airo is suitable for cranial, spine and trauma procedures, making it a highly versatile intraoperative imaging system.</span></p> <p><br /><span style="font-size: 10pt;">MDEA entries are judged by an impartial panel of experts from a range of disciplines&mdash;from engineers to designers to clinicians. </span><br /> <br /><span style="font-size: 10pt;"> <strong>&ldquo;</strong>We applaud our partner, Mobius Imaging, for achieving this gold award for design excellence&rdquo; says Stefan Vilsmeier, president and chief executive officer of Brainlab. &ldquo;As the exclusive distributor of Airo, and primary collaborator on the graphical user interface for Airo, we strongly believe it has the potential to positively alter the surgical space in many clinical fields. For us, the MDEA gold only confirms this potential.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The first Airo systems went into clinical use in April 2014.</span></p></div> Researchers reveal combinatorial code for the developing brain 2014-06-20T16:42:00Z 2014-06-20T16:42:00Z <div id="Introduction59" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at the Allen Institute for Brain Science have mapped the development of the mouse brain from the embryo to the adult, creating a preliminary genetic key that allows them to pinpoint the age and location of regions of the developing brain. This work lays the foundation for tracking regions of the mouse brain through development, which could have valuable implications for translational work in human brain developmental disorders. The research, profiling the publicly available Allen Developing Mouse Brain Atlas, is published in the journal <a href="" target="_blank">Neuron</a>.</strong></span></p> </div><div id="Text159" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In order to identify individual brain regions, and their age, researchers frequently turn to using genes that can be found exclusively in that particular region and time point. But truly specific so-called &ldquo;marker&rdquo; genes are actually quite rare, explains Michael Hawrylycz, investigator at the Allen Institute for Brain Science. &ldquo;Rather than relying on single genes, we were able to identify combinations of genes and use those combinations to create a unique code that can be used to place regions of the brain in space-time,&rdquo; says Hawrylycz.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The research team also captured evidence of how the brain develops from its earliest form of stacked primordial plates to its adult form with the more familiar geographic regions that begin to correspond to specialised functional divisions of the brain.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We can now place this important organisational transition from plates to regions within developmental time,&rdquo; says Carol Thompson, lead author and scientific programme manager at the Allen Institute for Brain Science. &ldquo;We already knew this transition took place, but now we understand the mechanics behind it at a much more detailed, molecular level.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Allen Developing Mouse Brain Atlas serves as an expansion of the original Allen Mouse Brain Atlas and identifies where genes are active in the brain over seven different ages, ranging from prenatal to adult. Rather than profiling every gene in the mouse genome, the researchers selected approximately 2,100 genes with particular importance in development, and used those to identify individual brain regions at different time points.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The Allen Developing Mouse Brain Atlas works like a Rosetta stone for the developing brain,&rdquo; says Allan Jones, chief executive officer of the Allen Institute for Brain Science. &ldquo;We can translate how and when genes are expressed into what is happening in the brain developmentally, making this resource a promising tool for better understanding and eventually treating brain developmental disorders and diseases.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />As with all Allen Brain Atlas resources, the data from the Allen Developing Mouse Brain Atlas are publicly available through the Allen Brain Atlas data portal at</span></p></div> Study proves navigated TMS fundamentally improves treatment and outcomes for brain tumour patients 2014-06-19T17:08:00Z 2014-06-19T17:08:00Z <div id="Introduction60" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A study published in the Oxford Journal&nbsp;<a href="" target="_blank"><span style="color: #800000;"><em>Neuro-Oncology</em></span></a>, &lsquo;Navigated transcranial magnetic stimulation improves the treatment outcome in patients with brain tumours in motor eloquent areas&rsquo;, looked at the outcomes of 365 motor eloquent brain-tumour patients. The study proved that integrating navigated transcranial magnetic stimulation (nTMS) into the surgical workflow to pre-operatively localise motor function has a significant impact on treatment and outcome.</strong></span></p> </div><div id="Text160" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The authors from Charit&eacute; University in Berlin, looked at using Nexstim&rsquo;s Navigated Brain Stimulation (NBS) System for pre-operative motor mapping. The study enrolled 250 consecutive patients and compared their outcomes to a matched pre-nTMS control group on 115 patients. The results of the NBS mapping impacted the surgical plan in 68% of the cases:</span><br /><br /></p> <ul> <li><span style="font-size: 10pt;">Disproving suspected involvement of the primary motor cortex in 25.1% of the cases</span></li> <li><span style="font-size: 10pt;">Expanded surgical indication by 14.8%</span></li> <li><span style="font-size: 10pt;">Achieved 18% more total resections</span></li> <li><span style="font-size: 10pt;">Progression free survival increased by 45% in patients with low grade gliomas</span></li> </ul> <p><br /><span style="font-size: 10pt;"> &ldquo;This is why we work to get this amazing technology to the clinics. Helping patients to get better care and provide neurosurgeons more tools for their important pre-operative&nbsp;planning is driving us further.&rdquo; &ndash; Janne Huhtala, chief executive officer, Nexstim.</span></p> <p><br /><span style="font-size: 10pt;">In their conclusions, the authors stated &ldquo;the impact of this study should go far beyond the neurosurgical community because it could fundamentally improve treatment and outcome, and its results will likely change clinical practice.&rdquo; The use of NBS for pre-surgical mapping provided crucial data that improved surgical planning and patient communication. nTMS has now been proven to enable more patients to undergo surgery, which in turn may lead to better neurological outcomes and higher survival rates in brain tumour patients.</span></p></div> Neurim Pharmaceuticals announces publication of positive effects of add-on Circadin in Alzheimer&apos;s disease patients 2014-06-19T16:55:00Z 2014-06-19T16:55:00Z <div id="Introduction61" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neurim Pharmaceuticals has announced publication of the results from an exploratory phase 2 randomised placebo-controlled clinical trial evaluating the safety and efficacy of add-on Circadin (Prolonged Release melatonin 2mg) to standard therapy in Alzheimer&rsquo;s disease patients. The study, published in the <a href="" target="_blank"><em>Clinical Interventions in Aging Journal</em></a>, demonstrates positive effects of the drug on cognitive performance and sleep maintenance in the Alzheimer&rsquo;s disease patients.</strong></span></p> </div><div id="Text161" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Endogenous melatonin levels are reduced already at preclinical Alzheimer&rsquo;s disease stages. Because melatonin is important for good sleep quality and because poor sleep quality has recently been linked to Alzheimer&rsquo;s disease, it was important to investigate whether replenishing the missing hormone would be beneficial in AD patients and whether such effects would be related to the improvement in sleep,&rdquo; says Tali Nir, head of clinical trials at Neurim Pharmaceuticals.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">In this study, 80 patients diagnosed with mild-to-moderate Alzheimer&rsquo;s disease, with and without insomnia co-morbidity, receiving standard therapy (acetylcholinesterase inhibitors with or without memantine) were randomly assigned in a double-blind manner to 2mg of Circadin or placebo treatment nightly for 24-weeks. The paper reports that patients treated with Circadin for six months had significantly better cognitive performance than those with placebo as measured by Instrumental Activities of Daily Living (IADL) and Mini Mental State Examination (MMSE). Mean Alzheimer&rsquo;s Disease Assessment Scale - cognition (ADAS-Cog) did not differ between groups. Sleep efficiency as measured by Pittsburgh Sleep Quality Index (PSQI) Component 4 also improved with Circadin. In a subgroup of patients suffering from comorbid insomnia, Circadin treatment resulted in significant and clinically meaningful effects vs. placebo in mean IADL (p=0.032), MMSE (+1.5 vs. -3 points, p=0.0177) sleep efficiency (p=0.04), and median ADAS-Cog values (-3.5 vs. +3 points, p=0.045). The treatment was well tolerated.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We are very pleased with the encouraging data demonstrating efficacy and safety of add-on Circadin for six months on cognitive functioning and sleep in patients with mild-moderate Alzheimer&rsquo;s disease. This publication comes at an exciting time when the causal relationship between sleep disturbance and the Alzheimer&rsquo;s disease-relevant accumulation of beta amyloid in brain was discovered,&rdquo; says Zisapel, chief science officer of Neurim Pharmaceuticals. &ldquo;This study demonstrates the significance of good sleep quality and melatoninergic mechanisms in improving both cognition and sleep problems in Alzheimer patients and calls for further focus of this mechanism in Alzheimer&rsquo;s disease treatment.&rdquo;&nbsp;</span></p></div> Floridian Community Bank supports NSU Concussion Management Clinic 2014-06-17T12:43:00Z 2014-06-17T12:43:00Z <div id="Introduction62" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Floridian Community Bank has announced that it will sponsor the Nova Southeastern University Concussion Management Clinic, one of the largest community-based sport concussion initiatives in the state of Florida.</strong></span></p> </div><div id="Text162" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The bank recently made a financial contribution to the NSU Clinic, which provides state-of-the-art concussion management services to the thirty-two public and private high schools in the Broward County Athletic Association. Services to high school students include baseline testing, education and outreach and post-injury care. These services help to advise doctors and parents of the severity of a head injury, treatment needed and when the student athlete can get return to the field/court.</span></p> <p><br /><span style="font-size: 10pt;">Joseph Marzouca, Floridian Community Bank chief executive officer, comments, &ldquo;At the bank, we like to give back to the communities we serve, whenever we can. When this opportunity was brought to us &ndash; we jumped on it. We hope to support similar efforts in the future as well.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Bank president Lee Frankhouser adds, &ldquo;We&rsquo;re very happy to be working with the team at Nova Southeastern on a cause that many of us at the bank feel so strongly about. We have all learned in the past few years how critically important concussion testing and treatment is, and we feel it is a necessity to support for South Florida&rsquo;s high school athletes.&rdquo;</span></p></div> Positive top-line results from phase 3 study investigating daclizumab high-yield process in MS 2014-06-17T12:36:00Z 2014-06-17T12:36:00Z <div id="Introduction63" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Biogen Idec&nbsp;and&nbsp;AbbVie&nbsp;have announced positive top-line results from the phase 3 DECIDE clinical trial, designed to evaluate the superiority of once-monthly, subcutaneous daclizumab high-yield process (DAC HYP) when compared to intramuscular interferon beta-1a (IFN &beta;-1a), as a potential treatment for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). Results showed that DAC HYP was superior on the study&rsquo;s primary endpoint, demonstrating a statistically significant 45% reduction in annualised relapse rate (ARR) compared to IFN &beta;-1a (p&lt;0.0001).</strong></span></p> </div><div id="Text163" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The results of the DECIDE study are compelling, with DAC HYP demonstrating robust efficacy compared to a current standard of MS care,&rdquo; says Gilmore O&rsquo;Neill, vice president, Global Neurology Clinical Development, Biogen Idec. &ldquo;As a potential once-monthly therapy with a novel mechanism of action, we believe that, if approved, DAC HYP will be an important treatment option for people living with MS.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The positive results in the DECIDE study represent achievement of an important milestone in the development of DAC HYP as a potential new treatment option for MS patients,&rdquo; says Michael Severino, executive vice president, Research and Development and chief scientific officer, AbbVie. &ldquo;Together, the companies are committed to working with regulatory agencies on filing plans for DAC HYP.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">DAC HYP showed superiority on the first secondary endpoint, number of new or newly enlarging T2-hyperintense lesions at week 96, with a 54% reduction relative to IFN &beta;-1a (p&lt;0.0001). On the second secondary endpoint, DAC HYP reduced the risk of three month confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS) by 16% over IFN &beta;-1a, which was not statistically significant (p=0.16). Using a pre-specified sensitivity analysis that accounted for 67 patients who did not have a confirmatory disability assessment, DAC HYP showed a 21% reduction in the risk of sustained disability progression (p=0.047).</span></p> <p><br /><span style="font-size: 10pt;">The safety profile of DAC HYP in the study was consistent with what has been observed in prior studies. The overall incidence of adverse events was comparable across the DAC HYP and IFN &beta;-1a treatment groups. In patients treated with DAC HYP compared to IFN &beta;-1a, there was an increased incidence of serious infections (4% vs. 2%), serious cutaneous reactions (2% vs. &lt; 1%), and elevations of liver transaminases greater than five times the upper limit of normal (6% vs. 3%). There were four deaths in the IFN &beta;-1a group and one death in the DAC HYP group, none of which was considered treatment related.</span></p> <p><br /><span style="font-size: 10pt;">Biogen Idec and AbbVie plan to work with regulatory agencies to determine appropriate timelines for filing. The companies intend to present detailed results from DECIDE at a future medical conference.</span></p></div> New insight into how the brain regulates its blood flow 2014-06-17T12:31:00Z 2014-06-17T12:31:00Z <div id="ImageMain64" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction64" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>In a new study&nbsp;published online in the&nbsp;<a href="" target="_blank"><em>Journal of the American Heart Association</em></a>, researchers at&nbsp;Columbia Engineering&nbsp;report that they have identified a new component of the biological mechanism that controls blood flow in the brain. Led by&nbsp;Elizabeth M C Hillman, associate professor of biomedical engineering, the team has demonstrated for the first time that the vascular endothelium plays a critical role in the regulation of blood flow in response to stimulation in the living brain.</strong></span></p> </div><div id="Text164" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We think we have found a missing link in our understanding of how the brain dynamically tunes its blood flow to stay in sync with the activity of neurons,&rdquo; says Hillman, who has a joint appointment in Radiology. &ldquo;Earlier studies identified small pieces of the puzzle, but we did not believe they formed a cohesive &lsquo;big picture&rsquo; that unified everybody&rsquo;s observations. Our new finding seems to really connect the dots.&rdquo;</span><br /><br /><span style="font-size: 10pt;">Understanding how and why the brain regulates its blood flow could provide important clues to understanding early brain development, disease, and ageing. The brain increases local blood flow when neurons fire, and this increase is what is detected by a functional magnetic resonance imaging (fMRI) scan. Hillman found that the vascular endothelium, the inner layer of blood vessels, plays a critical role in propagating and shaping the blood flow response to local neuronal activity. While the vascular endothelium is known to do this in other areas of the body, until now the brain was thought to use a different, more specialised mechanism and researchers in the field were focused on the cells surrounding the vessels in the brain.</span><br /><br /><span style="font-size: 10pt;">&ldquo;Once we realised the importance of endothelial signalling in the regulation of blood flow in the brain,&rdquo; Hillman adds, &ldquo;we wondered whether overlooking the vascular endothelium might have led researchers to misinterpret their results.&rdquo;</span><br /><br /><span style="font-size: 10pt;">&ldquo;We really hope that our work will encourage others to take a closer look at the vascular endothelium in the brain. So far, we think that our findings have far-reaching and really exciting implications for neuroscience, neurology, cardiovascular medicine, radiology, and our overall understanding of how the brain works,"&nbsp;she continues.</span><br /><br /><span style="font-size: 10pt;">The research was carried out in Hillman&rsquo;s&nbsp;Laboratory for Functional Optical Imaging, led by PhD student and lead author on the study, Brenda Chen. Other lab members who assisted with the study included PhD and MD/PhD students from Columbia Engineering, Neurobiology and Behavior, and Columbia University Medical Center.&nbsp;</span><br /><br /><span style="font-size: 10pt;">To tease apart the role of endothelial signalling in the living brain, they had to develop new ways to both image the brain at very high speeds, and also to selectively alter the ability of endothelial cells to propagate signals within intact vessels. The team achieved this through a range of techniques that use light and optics, including imaging using a high-speed camera with synchronised, strobe LED illumination to capture changes in the colour, and thus the oxygenation level of flowing blood. Focused laser light was used in combination with a fluorescent dye within the bloodstream to cause oxidative damage to the inner endothelial layer of blood brain arterioles, while leaving the rest of the vessel intact and responsive. The team showed that, after damaging a small section of a vessel using their laser, the vessel no longer dilated beyond the damaged point. When the endothelium of a larger number of vessels was targeted in the same way, the overall blood flow response of the brain to stimulation was significantly decreased.</span><br /><br /><span style="font-size: 10pt;">&ldquo;Our finding unifies what is known about blood flow regulation in the rest of the body with how it is regulated in the brain,&rdquo; Hillman explains. &ldquo;This has wider reaching implications since there are many disease states known to affect blood flow regulation in the rest of the body that, until now, were not expected to directly affect brain health.&rdquo; For instance, involvement of the endothelium might explain neural deficits in diabetics; a clue that could lead to new diagnostics tests and treatments for neurological conditions associated with broader cardiovascular problems."</span><br /><br /><span style="font-size: 10pt;">&ldquo;Improving our fundamental understanding of how and why the brain regulates its blood flow is key to understanding how and when this mechanism could be altered or broken,&rdquo; she says. &ldquo;We think this could extend to studies of early brain development, ageing, and diseases such as Alzheimer&rsquo;s and dementia.&rdquo;</span><br /><br /><span style="font-size: 10pt;">The team&rsquo;s research findings may also explain the effects of some drugs on the brain, and on the fMRI response to stimulation, since the vascular endothelium is exposed to chemicals in the bloodstream. &ldquo;Overall, this work could dramatically improve our ability to interpret fMRI data collected in humans, perhaps making it a better tool for doctors to understand brain disease,&rdquo; she adds.</span><br /><br /><span style="font-size: 10pt;">Hillman plans next to address the broad range of implications her latest finding may have. She wants to explore the effects of drugs and disease states on the coupling of blood flow to neuronal activity in the brain, and is now starting studies to explore fMRI data from a range of different disease states to see whether she can find signs of neurovascular dysfunction. She is also working on characterising the co-evolution of neuronal and haemodynamic activity during brain development and is beginning to develop new imaging tools that will enable non-invasive, inexpensive monitoring of brain haemodynamics in infants and children who cannot be imaged within an MRI scanner.</span><br /><br /><span style="font-size: 10pt;">This research is supported by the National Institutes of Health (through the National Institute of Neurological Disorders and Stroke) as well as the National Science Foundation, the Human Frontier Science Programme and the Rodriguez family.</span></p></div> Foreign body retrieval could be new indication for Trevo ProVue in the cerebrovascular system 2014-06-17T11:44:00Z 2014-06-17T11:44:00Z <div id="ImageMain65" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction65" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A case report has described the novel use of a stent for the removal of a foreign body from the cerebrovascular system.</strong></span></p> </div><div id="Text165" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the authors, Mouhammed R Kabbani <em>et al</em>, the case was a man with a large left cavernous internal carotid artery cerebral aneurysm. Primary coiling was initially attempted and when this failed, stent-assisted coiling was performed later on. During the primary coiling, a 10mmx40cm Complex Standard Penumbra coil (Penumbra) was used to frame the aneurysm. It prematurely detached and migrated into the anterior cerebral artery and could not be retrieved when negative suctioning was applied to the microcatheter (PX Slim, Penumbra).</span></p> <p><br /><span style="font-size: 10pt;">Kabbani and colleagues say that multiple failed attempts were made to retrieve the coil using 2mm and 4mm microsnares (Amplatz GooseNeck). Following these attempts the Trevo ProVue (Stryker) was used successfully.</span></p> <p><br /><span style="font-size: 10pt;">After the coil retrieval, a cerebral angiogram demonstrated a mild vasospasm of the distal pericallosal artery with no evidence of vascular injury or branch occlusion.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Strentrievers such as the Trevo ProVue and Solitaire (Covidien) are indicated for thrombectomy in acute ischaemic stroke. Because of their mechanical characteristics, they may be used as a reasonable additional tool [&hellip;] to retrieve foreign bodies from the cerebrovascular system when other devices fail,&rdquo; Kabbani <em>et al</em> say.</span></p> <p><br /><span style="font-size: 10pt;">Kabbani, speaking to <em>NeuroNews</em> says that in the future this device could be used more often for retrieval of foreign bodies in the cerebrovascular system but more case reports, such as his, are needed to support its use.</span></p></div> Alzheon to participate in Global Dementia Legacy Meeting 2014-06-16T12:50:00Z 2014-06-16T12:50:00Z <div id="Introduction66" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Alzheon has announced that it has been invited to participate in the world&rsquo;s first Global Dementia Legacy Event, hosted by the UK Secretary of State for Health, Jeremy Hunt, MP, and the World Dementia Envoy, Dennis Gillings, CBE. Alzheon&rsquo;s chief executive officer, Martin Tolar, will be among the political and industry leaders in attendance at the event along with leaders from the World Health Organisation, the Organisation for Economic Co-operation and Development, global Alzheimer&rsquo;s associations and charities, and investors.</strong></span></p> </div><div id="Text166" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Expanding on the initiatives of the G8 Dementia Summit held in December 2013, this conference will propose ways to increase and apply investments in dementia. Invited leaders will convene at the prestigious Guildhall in the City of London on June 19, 2014, to discuss finance and social impact investment in dementia &ndash; a condition for which the vast majority of patients suffer from Alzheimer&rsquo;s disease but also includes vascular dementia, Lewy body dementia, frontotemporal dementia and other causes of cognitive decline.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Alzheimer&rsquo;s disease is one of the largest medical, economic and social challenges of our time. In addition to addressing the human impact of this devastating disease on patients and their families, we must develop creative investment solutions to address the current impasse in Alzheimer&rsquo;s research and drug development,&rdquo; says Martin Tolar, founder, president and chief executive officer of Alzheon. &ldquo;We commend the initiative of the UK Prime Minister, David Cameron, and the UK Secretary of State for Health for continuing to build on the momentum of the G8 Dementia Summit to bring into action ways to increase investment in innovative approaches for addressing the unmet needs of patients with dementia around the world.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Global Dementia Legacy Event will explore ways that financial investment can support efforts to prevent, treat and support people to live well with dementia, including plans to establish a private and philanthropic Global Dementia Innovation Fund. At the conference, international experts and institutions will further define initiatives that build on the commitments agreed to by G8 leaders at the G8 Dementia Summit for a new international approach to dementia research, stimulating greater investment in innovation, securing greater collaboration, accelerating the development of new drugs for the prevention and treatment of dementia, and improving quality of life for people with dementia. </span><br /> <br /><span style="font-size: 10pt;"> &ldquo;Leaders from government, research and industry recognise the global crisis of dementia, affecting not only our patients but now also healthcare systems and economies across the world,&rdquo; Tolar comments further. &ldquo;At Alzheon, we are committed to rapidly advancing our novel drug candidate, ALZ-801, as one of the few innovative medicines with the potential to reach Alzheimer&rsquo;s disease patients in the next few years. We are honoured to continue to play a role in global leadership forums and to offer Alzheon&rsquo;s expertise to accelerate progress in our shared goal of bringing new treatments to patients with Alzheimer&rsquo;s disease and other neurodegenerative disorders.&rdquo;</span></p></div> Vantage one-year data shows highly significant improvement in motor scores for Parkinson&apos;s disease 2014-06-16T12:14:00Z 2014-06-16T12:14:00Z <div id="ImageMain67" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction67" style="clear:both;"> <p><span style="font-size: 11pt;"><strong><span style="color: black;">Patients with Parkinson&rsquo;s disease treated with the Vercise deep brain stimulation system from <strong>Boston Scientific&nbsp;</strong>demonstrated a highly significant and consistent improvement in motor scores, according to the latest one-year data.&nbsp; </span></strong></span></p> </div><div id="Text167" style="clear:both; text-align:left"><p><span style="color: black; font-size: 10pt;"><strong><a href=";rank=1" target="_blank">Vantage</a>&nbsp;(the&nbsp;</strong></span>Vercise implantable stimulator for treating Parkinson&rsquo;s disease trial)&nbsp;<span style="color: black; font-size: 10pt;">is a prospective, multicentre trial evaluating the Vercise deep brain stimulation system assessing patient outcomes in Parkinson&rsquo;s disease, including effectiveness, safety and health economic data.&nbsp;Forty patients with Parkinson&rsquo;s disease were treated with the&nbsp;</span>system at six European centres.</p> <p><span style="color: black; font-size: 10pt;"><br />Results of the follow-up were presented at the 18<sup>th</sup> International Congress of Parkinson&rsquo;s Disease and Movement Disorders in <span class="xn-location">Stockholm, Sweden</span> by <span class="xn-person">Lars Timmermann</span>, of University Hospital in Cologne<span class="xn-location">, Germany</span>. </span></p> <p><span style="color: black; font-size: 10pt;"><br />The Vantage study reported a 62% improvement in motor function at 12 months post implant, as assessed by the UPDRS III scale, when compared to baseline.&nbsp;This result is consistent with the six month interim data presented last year, demonstrating that patients benefitted from therapy over time.&nbsp;In addition, patients reduced medication usage by 58% at 12 months compared to their usage prior to the deep brain stimulation procedure.&nbsp; </span></p> <p><span style="color: black; font-size: 10pt;"><br />&ldquo;We are pleased to see not only a highly significant improvement in motor function over the longer term, but also a highly significant improvement in overall quality of life for the Vantage study patients,&rdquo; says Fran&ccedil;ois Alesch, professor of Stereotactic and Functional Neurosurgery at Medical University, <span class="xn-location">Vienna, Austria</span> and neurosurgical principal investigator of the trial.&nbsp;&ldquo;I believe these results are rooted in the Vercise deep brain stimulation system&rsquo;s multiple independent current control technology, which is designed for accurate neural targeting to improve patient outcomes and minimise the side effects of unwanted stimulation.&rdquo;</span></p> <p><span style="color: black; font-size: 10pt;"><br />The Vercise deep brain stimulation system has both CE mark and TGA (Australia Therapeutic Goods Administration) approval and is available for sale in <span class="xn-location">Europe</span>, <span class="xn-location">Israel</span>, <span class="xn-location">Australia</span> and select countries in <span class="xn-location">Latin America</span> for Parkinson&rsquo;s disease. It also has CE mark approval for intractable primary and secondary dystonia.&nbsp; </span></p> <p><span style="color: black; font-size: 10pt;"><br />In the USA, the Vercise deep brain stimulation system is investigational and not available for use or sale.&nbsp;The <a href=";rank=2" target="_blank">Intrepid</a> clinical trial began enrolment in the USA in mid-2013 to evaluate the safety and effectiveness of the Vercise deep brain stimulation system for the treatment of Parkinson&rsquo;s disease.&nbsp; </span></p></div> Northwestern Medicine brings hope to patients with severe epilepsy 2014-06-16T11:08:00Z 2014-06-16T11:08:00Z <div id="Introduction68" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Specialists at Northwestern Medicine&rsquo;s&nbsp;Comprehensive Epilepsy Center&nbsp;recently started using a new surgical procedure that could change the lives of epileptics who are unable to control their seizures with medication.</strong></span></p> </div><div id="Text168" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Stereoelectroencephalography, or SEEG, is a ground-breaking procedure that is used to surgically identify areas of the brain where epileptic seizures originate. During SEEG, doctors place electrodes on these areas, which are then monitored to precisely locate the seizure source. When the seizure onset is localised, these lesions are destroyed with lasers. In some cases the lasers go through the same holes created by the SEEG. Northwestern Memorial Hospital is one of just a few centres in the USA to offer SEEG as a treatment option for epilepsy.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This procedure is the safest and least invasive surgical option to treat epilepsy today,&rdquo; says&nbsp;Stephan Schuele, director of the Comprehensive Epilepsy Center and assistant professor in neurology at&nbsp;Northwestern University Feinberg School of Medicine. &ldquo;For people who do not respond to medication, this is a very effective surgery with a lower risk of complications compared to traditional epilepsy surgeries.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Because SEEG is more accurate and less invasive, patients experience better results and a shorter recovery time, Schuele adds.&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;SEEG is the perfect match of the latest medical advancements and leading edge technology, said&nbsp;Joshua Rosenow, director of functional neurosurgery at Northwestern Memorial and associate professor of neurological surgery, neurology, and physical medicine and rehabilitation at the Feinberg School.</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;SEEG allows us to locate exactly where the seizures start in the brain and on a microscopic level destroy some of these lesions,&rdquo; Rosenow says. &ldquo;The results are extremely promising. Once they recover from surgery, most of these patients live seizure-free lives.&rdquo;</span></p></div> BrainCare promotes brain wellness after stroke and traumatic brain injury 2014-06-13T17:00:00Z 2014-06-13T17:00:00Z <div id="Introduction69" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroTrax has announced the global availability of BrainCare, a cognitive assessment and report solution to aid clinicians in advancing brain wellness of stroke survivors and traumatic brain injury patients. &nbsp;</strong></span></p> </div><div id="Text169" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Science-based BrainCare standardises brain wellness assessment and tracking that measures progress toward regaining lost function. BrainCare&rsquo;s design provides structured patient assessment and reporting that also provide the healthcare professional with quality of care metrics related to brain exercises.</span></p> <p><br /><span style="font-size: 10pt;">The user-friendly BrainCare assessment includes a standardised set of computerised tests to identify cognitive and psychosocial factors. These tests cover six major areas of memory and thinking, as well as mood and nervousness:</span></p> <ul> <li><span style="font-size: 10pt;">Memory</span></li> <li><span style="font-size: 10pt;">Executive Function</span></li> <li><span style="font-size: 10pt;">Attention</span></li> <li><span style="font-size: 10pt;">Visual Spatial</span></li> <li><span style="font-size: 10pt;">Verbal Function</span></li> <li><span style="font-size: 10pt;">Problem Solving</span></li> </ul> <p><span style="font-size: 10pt;">Test results are then used to generate easy-to-read graphical reports for both the clinician and the patient. Additionally, BrainCare provides evidence-based patient activity recommendations that help healthcare professionals align test results with the latest scientific research on brain fitness and wellness.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Medical research supports brain exercise as a way to improve brain fitness. Since no two brain injuries are the same, it&rsquo;s important that patients have access to personalised cognitive assessments and fitness activities to advance their brain wellness. Our vision for BrainCare is to establish a standardised process in assessing and supporting brain wellness,&rdquo; says NeuroTrax chief executive officer&nbsp;Robert Pepper. &ldquo;BrainCare is designed to support clinician workflow with a patient-centric solution to help manage and monitor patient brain fitness.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">BrainCare is based on peer-reviewed scientific studies indicating that cognitive exercises performed following stroke and traumatic brain injury can improve brain wellness.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Over the past 25 years, there has been substantial progress in understanding factors essential to minimising cognitive deficits after stroke and traumatic brain injury. It is critical for patients to continue cognitive training over the long term in order to maximise their recovery,&rdquo; says Richard D Zorowitz, chairman, Department of Physical Medicine and Rehabilitation, Johns Hopkins Bayview Medical Center,&nbsp;Baltimore, Maryland, USA. &ldquo;BrainCare holds great promise of facilitating brain fitness by providing accessible scientific cognitive assessment and intuitive reports for tracking progress.&rdquo;</span></p></div> Parkinson’s disease trial shows that for long-term treatment levodopa is better than newer drugs 2014-06-12T12:41:00Z 2014-06-12T12:41:00Z <div id="ImageMain70" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction70" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>For long-term treatment of newly diagnosed Parkinson&rsquo;s disease, the old drug levodopa provides better mobility and a higher quality of life than the two main alternatives, dopamine agonists and monoamine oxidase type B inhibitors, according to the largest-ever trial of Parkinson&rsquo;s disease treatment (PD MED), published in <a href="" target="_blank"><em>The Lancet</em></a>.</strong></span></p> </div><div id="Text170" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Parkinson&rsquo;s disease is the second most common neurodegenerative disorder (after Alzheimer&rsquo;s) in the UK, with 8000 new cases each year and over 100,000 people living with the disease. The most widely used treatment is the drug levodopa, although after prolonged use patients can develop involuntary muscle spasms (dyskinesias) and motor fluctuations. There is less risk of developing these complications with dopamine agonists or with monoamine oxidase type B inhibitors than with levodopa, but other side effects including nausea, hallucinations, oedema, and sleep disturbance are increased with these newer drugs.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Previous studies included too few patients, had short follow-up, and focused on the clinicians&rsquo; assessments of motor symptoms rather than asking patients how the drugs affected their overall quality of life. So, for many years there has been uncertainty about the risks and benefits of starting treatment with these different classes of PD drugs,&rdquo; explains study leader Richard Gray from the University of Oxford in the UK.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The PD MED trial randomly assigned 1620 people with early Parkinson&rsquo;s disease to levodopa-sparing therapy (dopamine agonists or monoamine oxidase type B inhibitors) or levodopa. With up to seven years of follow-up, self-reported scores on scales measuring mobility and quality of life showed small but persistent benefits of starting treatment with levodopa rather than the other drugs. Patients in the levodopa group also reported significantly better scores on the activities of daily living, stigma, cognition, communication, and bodily discomfort scales than those taking levodopa-sparing therapy despite more involuntary muscle spasms.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to Gray, &ldquo;Although the differences in favour of levodopa are small, when you consider the short- and long-term benefits, side-effects, quality of life for patients, and costs, the old drug levodopa is still the best initial treatment strategy for most patients.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />He adds, &ldquo;In current clinical practice, most patients younger than 70 years are treated initially with a dopamine agonists to avoid levodopa-related motor complications. However, we found levodopa better than the more expensive dopamine agonists at all ages.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Carl Clarke, the clinical coordinator of the study from the University of Birmingham, UK, adds, &ldquo;The PD MED trial is the largest drug trial ever performed in Parkinson&rsquo;s disease. It is likely to change clinical practice worldwide, with the majority of patients from now on starting therapy with levodopa.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Writing in a linked Comment, Anthony Lang and Connie Marras from Toronto Western Hospital, Ontario, Canada say, &ldquo;PD MED provides reassuring data showing that in most patients with Parkinson&rsquo;s disease, who have an older age of onset, how treatment is initiated generally does not matter because outcomes are very similar&hellip; Finally, and perhaps most importantly, the results of this study will help to persuade physicians and reassure patients that the fears that have served as the groundwork in establishing levodopa phobia&mdash;that often results in patients experiencing unnecessary and easily managed disability and reduction in quality of life in the early years of their disease&mdash;are unfounded.&rdquo;</span></p></div> Trial shows gammaCore is effective in reducing cluster headaches 2014-06-11T16:12:00Z 2014-06-11T16:12:00Z <div id="ImageMain71" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction71" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>In a multicentre, randomised, trial across Europe, electroCore&rsquo;s non-invasive vagus nerve stimulation therapy was found to meet its primary endpoint of statistical significance in reducing the number of cluster headache attacks when compared with the standard of care. During weeks three and four following the beginning of therapy, the number of cluster headache attacks per week was reduced by 46.3% in patients treated with nVNS compared with 12.5% (p=0.002) in patients treated with the best available standard of care.</strong></span></p> </div><div id="Text171" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Charly Gaul, director of the Migraine and Headache Clinic K&ouml;nigstein, Germany and the principal investigator of the study comments; &ldquo;This study is one of the few well controlled, randomised studies of any preventative treatment for cluster headache. The ability of electroCore&rsquo;s gammaCore therapy to significantly reduce the number of weekly cluster headaches in these chronic patients suggests it offers an important new option for this extremely painful and difficult to manage condition.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The trial<em>&mdash;</em>Preva<em>&mdash;</em>which was conducted at ten sites across Europe was investigating both the prevention and acute treatment of chronic cluster headache. Patients delivered the non-invasive vagus nerve stimulation treatment by placing the gammaCore device on the skin over the vagus nerve in the neck prophylacticly twice daily (three stimulations per treatment) and optionally at the onset of a cluster headache.</span></p> <p><br /><span style="font-size: 10pt;">The trial enrolled 97 patients, and 93 were randomised to participate beyond the initial baseline data collection period. Forty five of the patients were randomly selected to use gammaCore and 48 to the best available standard of care. The baseline data collection period was two weeks, followed by the four week randomised phase. All subjects were permitted to continue on active therapy for an additional four weeks.</span></p> <p><br /><span style="font-size: 10pt;">The primary efficacy end point was the reduction in number of cluster headache attacks per week during the last two weeks of the randomised phase versus the baseline period. Additional end points included the proportion of subjects with more than 50% reduction in cluster headache attacks per week (response rate).</span></p> <p><br /><span style="font-size: 10pt;">Device related adverse events were primarily mild and transient. Full data from the randomised and open label portions of the study will be presented at medical meetings later this year.</span></p></div> FDA approves Apollo Onyx microcatheter 2014-06-11T15:32:00Z 2014-06-11T15:32:00Z <div id="ImageMain72" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction72" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Covidien has announced US Food and Drug Administration (FDA) approval of its Apollo Onyx delivery microcatheter<em>&mdash;</em>the first detachable tip micro catheter available in the USA. The new micro catheter is designed to mitigate the technical challenges of catheter retrieval during Onyx<sup>&nbsp;</sup>liquid embolic system embolisations of brain arteriovenous malformations.</strong></span></p> </div><div id="Text172" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A brain arteriovenous malformation occurs when a tangle of blood vessels in the brain or on its surface bypasses normal brain tissue and directly diverts blood from the arteries to the veins. Normally, arteries carry blood containing oxygen from the heart to the brain, and veins carry blood with less oxygen away from the brain and back to the heart. According to the American Heart Association, brain arteriovenous malformations occur in approximately one in 200 to 500 people and are more common in males than in females.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This new game-changing device will improve physicians&rsquo; options for treating patients with brain arteriovenous malformations,&rdquo; says Alejandro Berenstein, director, Center for Endovascular Surgery at the Hyman-Newman Institute for Neurology and Neurosurgery at Mount Sinai Health Systems in New York City, USA. &ldquo;The Apollo Onyx microcatheter provides a very important added safety mechanism for catheter retrieval during Onyx LES embolisations of brain arteriovenous malformations, permitting a more complete treatment in a much safer manner.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Apollo Onyx microcatheter enables physicians to choose the best catheter position for each procedure, according to the company. It can provide optimal navigability through complex distal anatomy as well as a proprietary detachable tip designed for easier catheter retrieval in challenging environments.</span></p> <p><span style="font-size: 10pt;"><br />The Apollo Onyx microcatheter will be showcased at the&nbsp;<a href="">Society of NeuroInterventional Surgery</a>&rsquo;s (SNIS)&nbsp;11th&nbsp;annual meeting (28<em>&ndash;</em>31 July; Colorado, USA).</span></p></div> Brain implant offers hope for epilepsy patients 2014-06-11T15:09:00Z 2014-06-11T15:09:00Z <div id="ImageMain73" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction73" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Physicians at Stanford Hospital &amp; Clinics now offer an implantable therapeutic device, designed to detect and treat seizures, for certain patients with epilepsy. The new treatment is an option for adults with intractable partial onset seizures, which are localised in one or two parts of the brain and that have not been controlled with two or more antiepileptic drugs. The device is the world&rsquo;s only responsive neurostimulation system and received US Food and Drug Administration (FDA) clearance on November 14, 2013. Stanford physicians have been studying the technology since 2004, and in June 2014, will implant their first device since approval.</strong></span></p> </div><div id="Text173" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The device continuously monitors brain electrical activity, senses abnormal electrical activity and responds by delivering unnoticeable pulses of electrical stimulation to normalise that activity before an individual experiences seizures.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Essentially, a person could be treated for an imminent seizure without even recognising it,&rdquo; says&nbsp;Robert Fisher, professor of neurology and neurological sciences and director of the comprehensive epilepsy programme at Stanford. &ldquo;While this isn&rsquo;t a cure for epilepsy, this technology reduces the number of seizures for some patients. This can improve quality of life for patients who previously did not have other satisfactory treatment options.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Of the approximately 65 million people worldwide who have epilepsy, 30-40% experience uncontrolled seizures. However, not all seizures are suitable for treatment by this device, since the location of the seizures in the brain must be known for it to be applicable.</span></p> <p><br /><span style="font-size: 10pt;">The battery-powered and microprocessor-controlled device is placed within the skull and beneath the scalp. It is connected to one or two leads that are placed within the brain or rest on the brain&rsquo;s surface in the area of the seizure focus. The procedure doesn&rsquo;t involve any removal of brain tissue.</span></p> <p><br /><span style="font-size: 10pt;">Physicians personalise therapy for each patient by non-invasively programming the detection and stimulation settings of the device. At home, patients can monitor and transmit recordings of their brain electrical activity and other information. The patient&rsquo;s physician can review and analyse this information over the internet between the patient&rsquo;s office appointments.&nbsp;</span></p> <p><span style="font-size: 10pt;">The responsive neurostimulation system is manufactured by NeuroPace.</span></p></div> Study results demonstrate advantages of Vercise 2014-06-11T14:22:00Z 2014-06-11T14:22:00Z <div id="ImageMain74" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction74" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A new study has demonstrated a therapeutic advantage for a unique and innovative capability of the Boston Scientific Vercise&nbsp;deep brain stimulation system for the treatment of Parkinson&rsquo;s disease.&nbsp;The <a href=";rank=1" target="_blank"><span style="color: #993300;">CUSTOM-DBS</span></a> clinical study demonstrated that shorter stimulation pulses may offer a clinical advantage over deep brain stimulation therapy using conventional pulses.&nbsp;The Vercise deep brain stimulation system is the only commercially available platform with the capability to generate stimulation pulses at the shorter pulse width settings.&nbsp;</strong></span></p> </div><div id="Text174" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Results of the CUSTOM-DBS study were presented at the 18<sup>th</sup> International Congress of Parkinson&rsquo;s Disease and Movement Disorders in Stockholm, Sweden, by Jens Volkmann, professor of Neurology at Universitatsklinikum, in Wurzburg, Germany and primary principal investigator of the trial. The Boston Scientific CUSTOM-DBS study is a randomised, multicentre, double-blind trial evaluating clinical advantages of the Vercise deep brain stimulation system for patients with Parkinson&rsquo;s disease.&nbsp;Fifteen patients previously implanted with the Boston Scientific Vercise deep brain stimulation system were programmed and assessed using test and control pulse widths.</span></p> <p><br /><span style="font-size: 10pt;">The study demonstrated that deep brain stimulation with shorter pulses results in larger therapeutic windows that may be advantageous for avoiding stimulation-related side effects.&nbsp;The therapeutic window is the range of electrical currents that provides effective therapy without causing side effects.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">In CUSTOM-DBS, patients&rsquo; deep brain stimulation implants were stimulated with brief electrical pulses that were shorter than conventional settings.&nbsp;To compare the two settings, efficacy of the stimulation was evaluated using the standard UPDRS III score assessment for Parkinson&rsquo;s disease, and thresholds for achieving efficacy and side effects were measured.&nbsp;The comparisons were randomised and double-blinded, making this one of the first studies to provide Level I evidence of a clinical advantage to specific deep brain stimulation settings, such as shorter pulse widths.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The results are truly exciting because the key to optimal deep brain stimulation treatment is first to get accurate targeting and then find an electrode with a large therapeutic window, where a patient is getting the best management of Parkinson&rsquo;s disease symptoms with minimal side effects,&rdquo; says Volkmann.&nbsp;&ldquo;The shorter pulse width settings with the Vercise system required less electrical energy to achieve optimal therapy, suggesting there may also be energy efficiency advantages to these settings as well.&rdquo;&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">The Vercise system has both CE mark approval and TGA (Australia Therapeutic Goods Administration) approval and is available for sale in Europe, Israel, Australia and select countries in Latin America for Parkinson&rsquo;s disease, and CE mark approval for intractable primary and secondary dystonia.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">In the USA, the Vercise system is investigational and not available for use or sale. The INTREPID clinical trial began enrolment in the USA in mid-2013 to evaluate the safety and effectiveness of the Vercise system for the treatment of Parkinson&rsquo;s disease.&nbsp;</span></p></div> FDA IDE approval for PulseRider 2014-06-10T11:43:00Z 2014-06-10T11:43:00Z <div id="ImageMain75" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction75" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Pulsar Vascular has announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for the PulseRider. The IDE allows Pulsar Vascular to begin a multicentre clinical trial in support of a humanitarian device exemption (HDE) to evaluate the PulseRider for US approval for wide neck aneurysms at or near a bifurcation of the basilar tip or carotid terminus. There are currently no devices approved by the FDA for this indication.</strong></span></p> </div><div id="Text175" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Adnan Siddiqui,&nbsp;Department of Neurosurgery,&nbsp;University at Buffalo, USA says, &ldquo;The treatment of bifurcation aneurysms is truly an unmet need in endovascular therapies. I am excited by the positive response to the PulseRider in Europe, and as part of the US clinical trial, I look forward to working with the company and the FDA, to bring this novel, innovative technology into my everyday practice.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Rob Abrams, the chief executive officer of Pulsar Vascular and co-creator of the PulseRider design, says, &ldquo;The FDA&rsquo;s approval of the PulseRider IDE allows us to initiate this important study for our flagship product and validates our scientific platform technology. This approval represents another significant milestone for Pulsar Vascular and a step forward on the path to providing a new treatment option to both patients and physicians.&rdquo; The clinical trial will be conducted at multiple clinical sites in the USA and is slated to begin Q3 2014.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">The PulseRider, which is designed to be fully retrievable and repositionable, received CE mark approval in late 2013 and it has been in use in Europe since early 2014. The device addresses an unmet clinical need to treat complex necked bifurcation aneurysms, and the European physicians have welcomed it into their practices. The company plans to expand the European market while the US clinical trial is underway.</span></p></div> FDA approves expanded label for Azilect 2014-06-10T10:36:00Z 2014-06-10T10:36:00Z <div id="ImageMain76" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction76" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The US Food and Drug Administration (FDA) has expanded the indication for Azilect (rasagiline tablets) from monotherapy and adjunct to levodopa to now include adjunct to dopamine agonists. The new indication reflects that Azilect can be used alone or in combination with other Parkinson&rsquo;s disease medications.</strong></span></p> </div><div id="Text176" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The FDA approval of the expanded label for Azilect&nbsp;will be a welcome addition in the treatment of Parkinson&rsquo;s disease,&rdquo; says Michael Hayden, president of Global Research &amp; Development and chief scientific officer at Teva Pharmaceutical Industries. &ldquo;Teva continues its commitment to those living with Parkinson&rsquo;s disease and to research in areas of neurodegenerative diseases to develop solutions for patients with unmet needs.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The FDA approval of the expanded label is based on a supplemental new drug application submitted by Teva, supported by data from the ANDANTE study (Add on<strong>&nbsp;</strong>to&nbsp;dopamine&nbsp;agonists in the&nbsp;treatment of Parkinson&rsquo;s disease).The study demonstrated Azilect&nbsp;provides a clinical benefit by significantly improving total Unified Parkinson&rsquo;s Disease Rating Scale (UPDRS) scores compared to placebo in patients on dopamine agonists monotherapy, while demonstrating tolerability.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Azilect&nbsp;has been well studied and has been shown to be safe and effective as monotherapy in early Parkinson&rsquo;s disease and as an adjunct to levodopa in moderate-to-advanced Parkinson&rsquo;s disease. The ANDANTE study provides evidence that Azilect&nbsp;is also effective as an adjunct to dopamine agonist therapy,&rdquo; says Robert A Hauser, professor of neurology, molecular pharmacology, and physiology at the University of South Florida, USA. &ldquo;The expanded Azilect&nbsp;indication supports the concept of adding Azilect&nbsp;to dopamine agonist monotherapy to improve symptoms while offering another treatment option prior to either increasing the dose of dopamine agonist monotherapy or initiating levodopa.&rdquo;</span></p></div> Enterprise stent was found to be a safe and effective revascularisation tool in stroke 2014-06-06T09:47:00Z 2014-06-06T09:47:00Z <div id="ImageMain77" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction77" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Previously, experience with the Enterprise vascular reconstruction device (Codman) has only been described in studies as a bailout procedure after primary stenting for acute ischaemic stroke with the Wingspan stent delivery system (Boston Scientific).</strong></span></p> </div><div id="Text177" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Elad L Levy, Department of Neurosurgery, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, USA) and colleagues therefore investigated the safety and effectiveness of the Enterprise for primary stenting for acute ischaemic stroke. They report their findings in the <a href="" target="_blank"><em>Journal of NeuroInterventional Surgery</em></a>.</span></p> <p><br /><span style="font-size: 10pt;">The study was a US Food and Drug Administration investigational device exemption prospective cohort study.</span></p> <p><br /><span style="font-size: 10pt;">The authors report that 20 patients who presented with acute ischaemic stroke due to intracranial large vessel occlusion were treated with the Enterprise within eight hours of symptom onset. The primary outcome was Thrombolysis In Myocardial Infarction (TIMI) flow of &ge;2. Perioperative safety was measured by major complication incidence within 30 days of revascularisation and a secondary outcome measure was 30-day modified Rankin Scale score.</span></p> <p><br /><span style="font-size: 10pt;">According to Levy <em>et al</em>, recanalisation to TIMI score 2 (n=6) or 3 (n=12) flow was achieved in 18 patients (90% revascularisation rate). Three major complications occurred (15%) and good outcome (modified Rankin Scale score) was achieved in 10 patients (50%).</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In this prospective study, the Enterprise stent was found to be a safe and effective revascularisation tool in the setting of acute ischaemic stroke,&rdquo; the authors conclude.</span></p> <p><br /><span style="font-size: 10pt;">Levy adds that the favourable qualities that make the Enterprise suitable for primary stenting in ischaemic stroke are effective navigability, the ability to retrieve after partial deployment and reasonable radial force. &nbsp;</span></p></div> MRI-guided laser procedure provides alternative to epilepsy surgery 2014-06-06T09:40:00Z 2014-06-06T09:40:00Z <div id="ImageMain78" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction78" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>For patients with mesial temporal lobe epilepsy (MTLE) that can&rsquo;t be controlled by medications, a minimally invasive laser procedure performed under MRI guidance provides a safe and effective alternative to surgery, suggests a study in the June issue of&nbsp;<a href="" target="_blank"><em>Neurosurgery</em></a>, official journal of the&nbsp;Congress of Neurological Surgeons.</strong></span></p> </div><div id="Text178" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Real-time magnetic resonance-guided stereotactic laser amygdalohippocampotomy (SLAH) is a technically novel, safe and effective alternative to open surgery,&rdquo; according to the new research by Robert E Gross of Emory University School of Medicine, Atlanta, USA, and colleagues.</span><br /> <br /><span style="font-size: 10pt;"> The researchers report their experience with MRI-guided SLAH in 13 adult patients with epilepsy mapped to a part of the brain called the mesial temporal lobe. The patients, median age 24 years, had &ldquo;intractable&rdquo; seizures despite treatment with antiepileptic drugs.</span></p> <p><br /><span style="font-size: 10pt;"> In the SLAH procedure, a saline-cooled fiberoptic laser probe was precisely targeted to the area of the brain&mdash;the &ldquo;amygdalohippocampal complex&rdquo;&mdash;responsible for the procedures. Using real-time MRI guidance, the neurosurgeon was able to pinpoint the area of the brain responsible for seizure activity and destroy (ablate) by computer-controlled laser energy, without harming neighbouring brain tissue.</span></p> <p><br /><span style="font-size: 10pt;"> The technical aspects of the procedure were successfully carried out in all patients. Using thermal imaging and MRI guidance, the surgeons were able to see the area of laser ablation as treatment proceeded. The average laser exposure time was just under 10 minutes.</span></p> <p><br /><span style="font-size: 10pt;"> On average, 60% of the amygdalohippocampal complex was destroyed in the SLAH procedure; the average length of the ablated area was 2.5 centimetres. Median time spent in the hospital was just one day&mdash;compared to a typical two to five-day stay after conventional temporal lobe surgery, and SLAH patients did not have to be admitted to the intensive care unit.</span></p> <p><br /><span style="font-size: 10pt;"> Most important, the procedure was effective in reducing or eliminating seizures in patients with MTLE. At a median of 14 months after SLAH, 10 out of 13 patients achieved meaningful seizure reductions, while seven were free of &ldquo;disabling seizures.&rdquo; This included six out of nine patients whose epilepsy was caused by an abnormality called mesial temporal sclerosis.</span></p> <p><br /><span style="font-size: 10pt;"> Although some complications occurred, none were directly caused by laser application. Two patients had an additional SLAH procedure to control seizures, and another patient underwent standard open surgery.</span><br /> <br /> <br /><span style="font-size: 10pt;"> Open brain surgery is the standard treatment for patients with intractable MTLE. Surgery has a high success rate, but carries a significant risk of neurological and cognitive (intellectual) impairment. Minimally invasive approaches like the new MRI-guided laser ablation technique might produce similar seizure control with lower risks than surgery.</span></p> <p><br /><span style="font-size: 10pt;"> The new study shows &ldquo;technical feasibility and encouraging results&rdquo; with the minimally invasive MRI-guided SLAH technique for patients with MTLE. Effectiveness in relieving or eliminating seizures approaches that of surgery&mdash;perhaps especially among patients whose seizures are caused by mesial temporal sclerosis. &ldquo;These are promising results considering that this reflects our initial experience, and results may improve with greater experience with this novel technique,&rdquo; notes Gross.</span></p> <p><br /><span style="font-size: 10pt;"> &ldquo;Such minimally invasive techniques may be more desirable to patients and result in increased use of epilepsy surgery among the large number of medically intractable epilepsy patients,&rdquo; Gross and colleagues conclude. They note that a larger, longer-term study of SLAH is underway, including assessment of the effects on cognitive function as well as seizures.</span></p></div> Clinical trial tests possible benefits of brain stimulation on hand and arm movement following stroke 2014-06-05T17:47:00Z 2014-06-05T17:47:00Z <div id="ImageMain79" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction79" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at Shepherd Center, Atlanta, USA, are studying whether stimulating the brain before rehabilitation could yield greater gains in motor function for people recovering from stroke. Researchers believe that the new approach could change common practices of care for certain stroke patients.</strong></span></p> </div><div id="Text179" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Shepherd Center is one of 12 US centres participating in a clinical trial that is evaluating whether coupling navigated transcranial magnetic stimulation (TMS) of the brain with standard occupational therapy can measurably improve hand and arm function following a stroke. Experts say this approach could unlock a totally new, non-invasive treatment to promote recovery and function.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;It&rsquo;s really a seminal study in neurorehabilitation that, if successful, will change common practices for how we take care of certain stroke patients,&rdquo; says Ford Vox, a physical medicine and rehabilitation physician at Shepherd Center and primary investigator for this study. &ldquo;We have this golden opportunity right after someone has a stroke when we know people are most likely to improve or recover function, and this therapy may offer patients the best potential.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Shepherd Center is testing a navigated brain stimulation system developed by a Finnish medical technology company called Nexstim. It uses transcranial magnetic stimulation therapy to apply a mild electromagnetic current to excite the brain, a technique that can be used to both investigate the brain&rsquo;s functions and change them. The technique is growing in popularity as a way to map the brain before surgery and as a treatment for depression. Nexstim&rsquo;s device provides visual guidance to the operator, who uploads and correlates MRI pictures of the patient&rsquo;s brain with the device&rsquo;s infrared guidance system. Then, the device creates a 3-D model of the patient&rsquo;s brain, pinpointing the target site for stimulation in real time (called stereotactic guidance).</span></p> <p><br /><span style="font-size: 10pt;">In this new trial, clinicians believe transcranial magnetic stimulation works by slowing activity in the healthy area of the brain, which can become overly active following a stroke, causing detriment to the injured side.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;By reducing brain activity on the side of the brain that was not injured, the injured side may actually have a better chance of recovery,&rdquo; Vox explains.</span></p> <p><br /><span style="font-size: 10pt;">The technology is akin to a more advanced version of constraint-induced therapy in which clinicians physically tie down a patient&rsquo;s good arm, which forces the patient to use the injured side. With Nexstim&rsquo;s non-invasive device, researchers are using electromagnetism to slow activity in portions of the healthy brain hemisphere that control the uninjured arm, similarly forcing the brain to use its injured half.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;People who have experienced a stroke often have limited resources and rehabilitation benefits,&rdquo; Vox notes. &ldquo;If initial results are confirmed, patients might be able to get that much more out of the limited time they have with therapists by using this technology.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Eligible clinical trial participants receive either the navigated brain stimulation or a sham (simulated) treatment in conjunction with six weeks of hand and arm therapy provided by an occupational therapist. Researchers and study participants do not know whether they are in the treatment or simulation group. Visits start with 20 minutes of standardised, task-oriented activity followed by the treatment or simulated therapy and then an hour of upper-limb rehabilitation therapy.</span></p> <p><br /><span style="font-size: 10pt;">The goal is to improve a patient&rsquo;s range of motion, coordination, flexibility, strength, and use of the weak arm and hand. Specifically, researchers are interested to see whether &ndash; at the end of the study &ndash; patients are better able to perform daily activities, such as dressing, grooming, cooking, doing laundry, writing, typing and leisure activities. For example, is a patient now able to button a shirt that he couldn&rsquo;t before, open a jar or screw-top bottle, pour beverages, manipulate keys to lock and unlock doors, use a phone or fold laundry?</span></p> <p><br /><span style="font-size: 10pt;">In a similarly designed pilot study of the device conducted at the Rehabilitation Institute of Chicago, researchers found striking improvements in motor function among people receiving the targeted stimulation compared with those in the simulation group. At six months post-stroke, these patients were 30% more likely to have meaningful arm recovery (80% compared with just 50%). Researchers presented their findings in February 2014 at the American Heart Association and the American Stroke Association&rsquo;s International Stroke Conference.</span></p></div> Mayo Clinic moves small-molecule drugs through blood-brain barrier 2014-06-05T17:06:00Z 2014-06-05T17:06:00Z <div id="Introduction80" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at Mayo Clinic have demonstrated in a mouse model that their recently developed synthetic peptide carrier is a potential delivery vehicle for brain cancer chemotherapy drugs and other neurological medications. The findings appear in <a href="" target="_blank"><em>PLOS ONE</em></a>.</strong></span></p> </div><div id="Text180" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Not only have we shown that we can transport eight different molecules, we think this method will be less disruptive or invasive because it mimics a normal physiological process,&rdquo; says Mayo Clinic neuroscientist Gobinda Sarkar, the corresponding author of the study. The researchers are able to transport the drugs without modifying any of the molecules involved. They say this development will aid in evaluation of potential new drugs for brain cancer.</span></p> <p><br /><span style="font-size: 10pt;">The blood-brain barrier is meant to protect the brain from numerous undesirable chemicals circulating in the body, but it also obstructs access for treatment of brain tumours and other conditions. Too often the only recourse is invasive, which often limits a drug&rsquo;s effectiveness or causes irreversible damage to an already damaged brain. Nearly all of the drugs that could potentially help are too large to normally pass through the barrier. Additionally, other methods may damage the vascular system.</span></p> <p><br /><span style="font-size: 10pt;">In this case, the synthetic peptide K16ApoE, once injected into a vein, binds to proteins in the blood to create entities that can pass for near-normal ligands to some receptors present on the blood-brain barrier. The &lsquo;pseudo-ligand&rsquo; receptor interaction creates what the researchers believe to be transient pores through which various molecules can be transported to the brain. The molecules they&rsquo;ve transported in this manner include cisplatin, methotrexate, cetuximab, three different dyes, and synthetic peptides Y8 and I-125. The researchers believe this is the least complicated, least expensive and most versatile method for delivering therapeutics to the brain. Previously, the researchers delivered antibodies targeted against amyloid plaques into the brains of mouse models of Alzheimer&rsquo;s disease using this same method.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We know that some chemotherapeutic agents can kill brain tumour cells when they are outside the brain (as in a laboratory test). But because the agents cannot cross the blood-brain barrier, they are not able to kill brain tumour cells inside the brain. With the peptide carrier, these agents can now get into the brain and potentially kill the tumour cells,&rdquo; says Mayo neurology researcher Robert Jenkins, senior author of the study.</span></p> <p><br /><span style="font-size: 10pt;">The researchers say their method, which has been successfully demonstrated in mice, meets three of five requirements for a usable therapy: It&rsquo;s feasible as a repeated procedure; it should be relatively easy to introduce into medical practice; and it would work for any size or location of brain tumour. More research will need to be done to prove effectiveness and determine any adverse effects.</span></p> <p><br /><span style="font-size: 10pt;">The research was supported by Mayo Clinic, Bernie and Edith Waterman, and the Ting Tsung and Wei Fong Chao Family Foundation. Co-authors include Geoffry Curran, Jann Sarkaria, and Val Lowe, all of Mayo Clinic.</span></p></div> Europe’s neurologists join forces in the European Academy of Neurology 2014-06-05T12:51:00Z 2014-06-05T12:51:00Z <div id="ImageMain81" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction81" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Europe will now have just one international neurological association. The two European societies &ndash; European Federation of Neurological Societies (EFNS) and European Neurological Society (ENS) &ndash; have merged during the Joint Congress of European Neurology in Istanbul, Turkey to create the new European Academy of Neurology (EAN). G&uuml;nther Deuschl from Kiel, Germany, was elected the first president of the new organisation.</strong></span></p> </div><div id="Text181" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">G&uuml;nther Deuschl is professor of Neurology and chairman of the Department of Neurology, Christian-Albrechts-Universit&auml;t, Kiel. His special interests include deep brain stimulation and tremor. &ldquo;I am sure that this merger will move European neurology into a pole position,&rdquo; the new EAN president says. &ldquo;We want to stand together to fulfil the mission of this new society. It includes taking the lead in terms of neurological practice and education on this continent and defining standards of patient care in Europe, a region which is underway to harmonising its health systems. This society also has a huge potential when it comes to promoting scientific progress in neurology and neurosciences in general.&rdquo;</span></p> <p><span style="font-size: 10pt;"><strong><br /></strong>The General Assembly of the EAN also elected the following officers to serve on the board of the new organisation:</span><br /><span style="font-size: 10pt;"><strong> <br /> </strong>Vice president: Franz Fazekas, Graz, Austria; </span><br /><span style="font-size: 10pt;"> Secretary general: Didier Leys, Lille, France</span><br /><span style="font-size: 10pt;"> Treasurer: Marianne de Visser, Amsterdam, The Netherlands </span><br /><span style="font-size: 10pt;"> Chair Scientific Committee: Antonio Federico, Siena, Italy </span><br /><span style="font-size: 10pt;"> Chair Liaison Committee: David Vodusek, Ljubljana, Slovenia</span><br /><span style="font-size: 10pt;"> Member at large: Per Soelberg Sorensen, Copenhagen, Denmark</span></p> <p><br /><span style="font-size: 10pt;">The first EAN Congress is scheduled to take place in Berlin, Germany in June 2015.</span></p></div> Breakthrough in Alzheimer&apos;s disease: AFFiRiS halted clinical progression in Alzheimer patients upon treatment with AD04 in a phase II clinical study 2014-06-05T12:31:00Z 2014-06-05T12:31:00Z <div id="ImageMain82" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction82" style="clear:both;"> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 11pt;"><strong><span style="font-family: Helvetica, sans-serif; color: #333333;">AFFiRiS AG of<span class="apple-converted-space">&nbsp;</span><span class="xn-location">Vienna, Austria</span>, has released for the first time results of a clinical phase II study in Alzheimer patients of its proprietary compound AD04, a therapeutic drug against Alzheimer&rsquo;s disease. The results show an impressive therapeutic effect of AD04 and make it the first ever compound demonstrating clinical and biomarker evidence consistent with disease modification of Alzheimer&rsquo;s disease. A statistically significant correlation was demonstrated between the cognitive/functional outcome and the volume of the hippocampus, the region of the brain locating the cognitive/memory functions, both of which demonstrated positive impact on disease progression over 18 months. Similar stabilisation was also seen across behavioural and quality of life outcomes.</span></strong></span></p> </div><div id="Text182" style="clear:both; text-align:left"><p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">There was also a stabilisation of the cognitive/functional endpoint found in those patients of this study who were treated with AD02, so far the company&rsquo;s lead compound in AD. Dependent on dosage and formulation of AD02 in three different study arms, 24-31% of the patients showed cognitive/functional stabilisation or improvement. However, statistically significant correlation with biomarker Hippocampus volume could not be demonstrated within the observation period of 18 months. Altogether 332 patients were treated in an international multicentric clinical trial into five different study arms, and over 85% completed the study.</span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt;"><strong><span style="font-family: Helvetica, sans-serif; color: #333333;">Significant Impact</span></strong><span style="font-family: Helvetica, sans-serif; color: #333333;">&nbsp;</span></span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">Commenting on these results, <span class="xn-person">Walter Schmidt</span>, chief executive officer and co-founder of AFFiRiS AG, states: &ldquo;Our results demonstrate that AD04 is the first drug ever to show disease modifying properties in Alzheimer&rsquo;s patients. This success is owed to our strategy of clinical maturation, which in the case of Alzheimer&rsquo;s has so far moved forward four different product candidates namely AD01 - AD04 into clinical development.&rdquo;</span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt;"><span class="xn-person"><span style="font-family: Helvetica, sans-serif; color: #333333;">Frank Mattner</span></span><span style="font-family: Helvetica, sans-serif; color: #333333;">, chief scientific officer and co-founder, adds: &ldquo;Both compounds applied in this trial, AD02 and AD04, showed excellent safety profiles. Top compound AD02 performed very well in stabilisation of cognitive functions in a dose dependent manner. 24-31 % of treated patients showed stabilisation of clinical progression. However, AD04 turned out to be superior to AD02 as 47% of the patients stabilised regarding their cognitive/functional status. On top of this, this effect was statistically significantly correlated with the rescue of the hippocampus, the region of the human brain, where cognitive and memory functions are located (p=0.0016). This correlation of significant clinical and biomarker effects meets EMA&rsquo;s and FDA&rsquo;s definition of disease modification in the context of a compound with a consistent mode of action. Therefore, we decided to have a strong focus on AD04 for further clinical development. Our strategy of clinical maturation allows for an efficient progress during clinical development. By doing so, it reduces financial risks associated with any clinical trial.&rdquo; In fact, the clinical maturation strategy has been established by AFFiRiS and is based on parallel clinical testing of several drug candidates against a certain disease to ensure that the best therapy for humans will be developed.&rdquo;</span></span></p></div> A new approach to Alzheimer&apos;s disease research 2014-06-05T12:12:00Z 2014-06-05T12:12:00Z <div id="Introduction83" style="clear:both;"> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 11pt;"><strong><span style="font-family: Helvetica, sans-serif; color: #333333;">As part of its ongoing research to better understand the complexities of the human brain, the Allen Institute for Brain Science, Seattle, USA, is embarking on the first effort to map connectivity patterns across the whole brain in mouse models of Alzheimer&rsquo;s disease, through its recent award of a<span class="apple-converted-space">&nbsp;US</span><span class="xn-money">$3.4 million</span><span class="apple-converted-space">&nbsp;</span>grant over five years from the National Institute on Aging of the National Institutes of Health.&nbsp;</span></strong></span></p> </div><div id="Text183" style="clear:both; text-align:left"><p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">&ldquo;Many studies on Alzheimer&rsquo;s disease focus on just one or a small number of areas in the brain, such as the hippocampus, for its role in memory,&rdquo; says<span class="apple-converted-space">&nbsp;</span><span class="xn-person">Julie Harris</span>, assistant investigator at the Allen Institute for Brain Science and primary investigator on the grant. &ldquo;By studying connections across the entire cortex in both normal mice and mouse models of the disease, we hope to finally make the breakthroughs that will help us understand the pathways through which Alzheimer&rsquo;s disease spreads, and what interventions we can make against its progression.&rdquo;</span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">So far, clinical trials for drugs developed in mouse models that typically focus on individual brain areas have yielded poor results. &ldquo;Our expanded view of the disease that looks at connections across the whole brain will hopefully improve mouse models and their use in translational research to identify drugs and treatments that work in humans,&rdquo; says Harris.</span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">The whole-brain model of Alzheimer&rsquo;s builds on the Allen Mouse Brain Connectivity Atlas, recently profiled in the journal<span class="apple-converted-space">&nbsp;</span><em>Nature</em>, which allows researchers to quantitatively analyse connections across the entire mouse brain.</span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">Harris and her colleagues plan to expand the resource by focusing on areas of the brain that are hardest hit early in the disease. They will work backwards first, using viral tracers to discover which regions of the brain send their neurons to those hard-hit areas. Then, they will follow the other projections from those source regions to different parts of the brain, ultimately creating a detailed map showing how and which brain regions are interconnected, and how these connections are altered by disease. In the spirit of other Allen Institute resources, they plan to make the data publicly available through the Allen Brain Atlas data portal.</span></p></div> USA&apos;s first mobile stroke unit successfully transports first patient 2014-06-05T11:49:00Z 2014-06-05T11:49:00Z <div id="ImageMain84" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction84" style="clear:both;"> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 11pt;"><strong><span style="font-family: Helvetica, sans-serif; color: #333333;">The<span class="apple-converted-space">&nbsp;</span><span class="xn-org"><span style="box-sizing: border-box;">University of Texas Health Science Center at Houston</span></span><span class="apple-converted-space">&nbsp;</span>(UTHealth) Medical School, in partnership with Memorial Hermann-Texas Medical Center (TMC), USA, has announced that the UTHealth Mobile Stroke Unit has successfully transported and helped save the life of its very first patient.&nbsp;</span></strong></span></p> </div><div id="Text184" style="clear:both; text-align:left"><p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; font-size: 10pt;">The unit, which is the first and only of its kind in the nation treating patients, is a specially-equipped ambulance with a CT (computed tomography) scanner that allows a stroke unit team member to quickly assess whether a patient is having a stroke caused by a blood clot and, if so, the clot-buster tPA (tissue plasminogen activator) can be administered.&nbsp;</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; font-size: 10pt;">Since becoming fully licensed and ready to go live late last month, the unit was dispatched for the very first time to 30-year-old Maureen Osaka&rsquo;s home near downtown<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Houston</span></span><span class="apple-converted-space">&nbsp;</span>after 911 received a call from<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Osaka&rsquo;s</span></span><span class="apple-converted-space">&nbsp;</span>friend that the woman was suffering from stroke-like symptoms.</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; font-size: 10pt;">Upon arrival, the mobile stroke unit team assessed<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Osaka</span></span><span class="apple-converted-space">&nbsp;</span>then moved her into the ambulance where they immediately started the CT scan. Within minutes, they were able to confirm<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Osaka</span></span><span class="apple-converted-space">&nbsp;</span>was not only suffering a stroke but probably had one of the rarest and most fatal types of stroke, a basilar artery occlusion, which means the blood clot was blocking an artery that provides blood to the brain stem.</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; font-size: 10pt;">Having the critical information they needed from the scan, the team was able to begin administering tPA treatment on site, before the ambulance even left the scene for the<span class="apple-converted-space">&nbsp;</span>Comprehensive Stroke Center<span class="apple-converted-space">&nbsp;</span>at the Mischer Neuroscience Institute at Memorial Hermann-TMC.&nbsp;&ldquo;The type of stroke that<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Osaka</span></span><span class="apple-converted-space">&nbsp;</span>suffered is often difficult to diagnose, so in addition to speeding treatment, the Mobile Stroke Unit brings specialised stroke expertise right to the patient&rsquo;s home at a time when it is needed most,&rdquo; says<span class="apple-converted-space">&nbsp;</span>James C Grotta, the neurologist who led the team that treated<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Osaka</span></span><span class="apple-converted-space">&nbsp;</span>that day.</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; font-size: 10pt;">&ldquo;Tissue plasminogen activator is the only FDA-approved treatment for an ischaemic stroke, but it must be given within three hours of the first signs of stroke to be most effective,&rdquo; adds Grotta, who is also director of stroke research in the Clinical Institute for Research &amp; Innovation at Memorial Hermann-TMC and director of the mobile stroke unit consortium that will also include the stroke teams from Houston Methodist Hospital and St. Luke&rsquo;s Medical Center, local businesses and philanthropists.&nbsp;&ldquo;It typically takes an hour once a stroke patient arrives in the emergency room to receive treatment, and that&rsquo;s not counting transport time. In these situations, every minute &ndash; every second &ndash; counts, so the earlier the clinical team can intervene, the better the outcome.&rdquo;</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt;"><span style="font-family: Helvetica, sans-serif;">&ldquo;<span class="xn-location">Osaka</span></span><span class="apple-converted-space">&nbsp;</span>was treated approximately 78 minutes after she first felt sick. Fewer than 1% of all stroke patients are treated that quickly. When she first arrived at the Memorial Hermann-TMC Emergency Center, her basilar artery was still blocked, but by the time the team got her up to the endovascular suite to try to extract the clot, it had already largely dissolved,&rdquo; explains Grotta.</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; font-size: 10pt;">The stroke unit is run in conjunction with the Emergency Medical Services of the<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Houston</span></span><span class="apple-converted-space">&nbsp;</span>Fire Department,<span style="box-sizing: border-box;"> <span class="xn-location">Bellaire</span></span><span class="apple-converted-space">&nbsp;</span>Fire Department and West University Fire Department. It carries a paramedic, neurologist, nurse and CT technician and runs alternate weeks as part of a clinical trial at UTHealth. The trial, which is expected to last three years, includes the telemedicine program that is part of UTHealth and the Mischer Neuroscience Institute at Memorial Hermann-TMC. Researchers are looking at whether the telemedicine programme, which physicians across the state use to consult with UTHealth stroke experts affiliated with Memorial Hermann-TMC, can be applied to the mobile stroke unit. If so, the unit might be able to respond to calls in the future using telemedicine, which could make it more cost effective.</span></p></div> FDA clears Night Shift therapy 2014-06-03T11:27:00Z 2014-06-03T11:27:00Z <div id="ImageMain85" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction85" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Advanced Brain Monitoring has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for Night Shift, a therapy for positional obstructive sleep apnoea.</strong></span></p> </div><div id="Text185" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Worn on the back of the neck, Night Shift begins to vibrate when users begin to sleep on their back and slowly increases in intensity until a position change occurs. Night Shift is also an intelligent, interactive monitor that allows users to track its effect on snoring and sleep quality.&nbsp;<a href=";rank=2" target="_blank"><strong>Clinical study</strong></a> results&nbsp;showed that 89% of participants responded to Night Shift therapy, with the majority experiencing improved sleep quality, reduced loud snoring and improvements in sleep apnoea symptoms.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In our study we found that 70% of individuals with obstructive sleep apnoea are at least twice as severe while sleeping on their back and may benefit from Night Shift therapy,&rdquo; states Daniel Levendowski, principal investigator for the study. Most snore more loudly when sleeping on their back, an annoyance that interrupts the sleep of the bed partner.</span></p> <p><br /><span style="font-size: 10pt;">Night Shift is immediately available through an&nbsp;Indiegogo crowdfunding campaign&nbsp;until June 22. The campaign allows participants to obtain the Night Shift at a substantially discounted price and includes a number of additional benefits.</span></p></div> Constant Therapy launches iPad solution for people with traumatic brain injury, stroke, aphasia and learning disabilities 2014-06-03T11:17:00Z 2014-06-03T11:17:00Z <div id="ImageMain86" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction86" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Constant Therapy has officially launched its innovative iPad rehabilitation solution&nbsp;with&nbsp;special pricing and trial offers.</strong></span></p> </div><div id="Text186" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Designed to be used independently by anyone seeking to improve brain function or in conjunction with a clinician as an integral part of therapy, this new mobile solution integrates ground-breaking research on brain plasticity and rehabilitation from Boston University (USA) and other leading institutions. It also incorporates years of research and a self-learning algorithm leveraging a comprehensive brain performance database for the brain-impaired population. Currently offered as an iPad solution, it is now in use across the USA with thousands of patients and clinicians at prominent, nationally recognised healthcare institutions, including Spaulding Rehabilitation Hospital, The Stroke Comeback Center and Moss Rehab Aphasia Center.</span></p> <p><br /><span style="font-size: 10pt;">According to<em>&nbsp;</em>Veera Anantha, co-founder and chief executive officer, &ldquo;Constant Therapy&nbsp;is vastly different from many of the brain improvement and rehabilitation apps available today. Instead of simply replicating standard brain exercises and flashcards, the application&rsquo;s&nbsp;NeuroPerformance Engine&nbsp;creates a highly customised and detailed map of each user&rsquo;s strengths and deficits across 50 different categories. The solution then delivers the optimum combination of exercises that are uniquely tailored to each user&rsquo;s deficit profile. Furthermore, as people use the system, it continuously measures their performance and encourages constant user progress with fresh and engaging content.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">While it has been a long held opinion that brain injury and stroke survivors reach a progress plateau after limited therapy, recent research has proven this wrong (&ldquo;Time to rethink long-term rehabilitation management of stroke patients,&rdquo; 2012; &ldquo;Therapeutic interventions for aphasia initiated more than six months post stroke: a review of the evidence,&rdquo; 2012&nbsp;). In fact, brain injury and stroke survivors can continue to improve if they have access to effective brain rehabilitation. Unfortunately, many stroke and brain injury survivors stop progressing simply because they are no longer able to obtain therapy that would keep them progressing.&nbsp;Constant Therapy&nbsp;changes all this by making it possible for millions of stroke and brain injury survivors to continue to improve, take control of their rehabilitation and change their lives.</span></p> <p><br /><span style="font-size: 10pt;">According to a company release, clinicians and patients already using&nbsp;Constant Therapy&nbsp;have described the life changing effects it has had on patients&rsquo; lives. Therapists are able to monitor their clients&rsquo; progress even when patients are using the app at home; some have also used it for tele-therapy. Patients have found that&nbsp;Constant Therapy&nbsp;allows them to obtain more therapy beyond their traditional clinical sessions, and have observed continued progress even when their therapy visits &ldquo;have run out.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Brain injury and stroke survivors can continue to make long-term progress in regaining speech, language, and cognitive skills if they have access to directed therapies,&rdquo; says Darlene Williamson, executive director of the&nbsp;Stroke Comeback Center&nbsp;and president of the National Aphasia Association. &ldquo;This is why&nbsp;Constant Therapy&nbsp;is such an important solution &ndash; it helps those who no longer have access to conventional therapy to make progress well after traditional therapy has ended.&rdquo;</span></p></div> Lemtrada resubmission accepted for review by FDA 2014-06-02T11:04:00Z 2014-06-02T11:04:00Z <div id="ImageMain87" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction87" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Genzyme has announced that the US Food and Drug Administration (FDA) has accepted for review the company&rsquo;s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada&nbsp;(alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter.</strong></span></p> </div><div id="Text187" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This resubmission is based on data from the same clinical studies included in the original sBLA, and provides supplemental analyses and additional information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter. The company resubmitted the sBLA earlier this month following constructive discussions with the agency.</span></p></div> Angiochem to present positive central nervous system and peripheral anti-tumour activity of ANG1005 at ASCO 2014-06-02T10:56:00Z 2014-06-02T10:56:00Z <div id="Introduction88" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Angiochem has announced the presentation of data for its lead drug candidate, ANG1005, a novel paclitaxel-peptide drug conjugate, at the American Society of Clinical Oncology (ASCO) 50<sup>th</sup>&nbsp;Annual Meeting in Chicago, USA. Phase 1 and phase 2 clinical studies demonstrated promising signs of both central nervous system and peripheral anti-tumour activity of ANG1005 in patients with brain metastases including breast cancer patients. Based on these data, Angiochem has also announced that the company has initiated a phase 2 clinical trial with ANG1005 designed to confirm this anti-tumour activity as a potential new approach to treating HER2+ breast cancer.</strong></span></p> </div><div id="Text188" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The data being presented on our lead product candidate, ANG1005, underscores its potential utility in treating brain and peripheral metastases from breast cancer and other solid tumours,&rdquo; says Jean Paul Castaigne, president and chief executive officer of Angiochem. &ldquo;Effective management of patients with brain metastases continues to be a major clinical challenge. By actively penetrating the blood-brain barrier and cancer cells through LRP-1 receptor, ANG1005 elicits both central nervous system and peripheral tumour responses and provides a potential new treatment option for this difficult to treat patient population.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The data to be presented at ASCO includes results from a phase 1 and initial phase 2 clinical studies of ANG1005 in HER2+ and HER2- breast cancer patients and solid tumours with brain metastases in which promising signs of anti-tumour activity were observed both in central nervous system and at the periphery. These studies support the advancement of the newly-initiated comprehensive phase 2 clinical study for ANG1005 in HER2+ breast cancer patients with brain metastases.</span></p> <p><br /><span style="font-size: 10pt;">ANG1005 represents a first-in-class oncology product that leverages the low density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier and enter cancer cells. In addition to the newly-initiated comprehensive phase 2 clinical study in patients with progressive or recurrent brain metastases from HER2+ breast cancer, ANG1005 is also being evaluated in an ongoing phase 2 clinical study in patients with primary brain cancers such as recurrent glioblastoma multiforme and anaplastic glioma.</span></p></div> NeuroBlate system for minimally invasive ablation of brain lesions to be presented at neurosurgery meeting 2014-06-02T10:31:00Z 2014-06-02T10:31:00Z <div id="ImageMain89" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction89" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Monteris Medical has announced that the NeuroBlate&nbsp;system for MR-guided neurosurgical ablation will be presented to members and attendees at the biennial meeting of the American Society of Stereotactic and Functional Neurosurgery (31 May&ndash;3 June; Washington, DC, USA). Gene Barnett, director of the Rose Ella Burkhardt Brain Tumor and NeuroOncology Center at the Cleveland Clinic, will present his experience utilising NeuroBlate system laser ablation in patients with brain tumours and radiation necrosis.</strong></span></p> </div><div id="Text189" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Barnett and his colleagues have shown that by employing magnetic resonance (MR) imaging and software based visualisation offered by the NeuroBlate system they are often able to completely ablate tumours through a very small hole in the skull. They published their results in the May issue of the online Journal <a href="" target="_blank"><em>Cancer Medicine</em></a>.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We are pleased to have the NeuroBlate system included in this scientific meeting agenda,&rdquo; says John E Schellhorn, president and chief executive officer of Monteris Medical. &ldquo;Patients who have received this minimally invasive laser ablation therapy for brain lesions have gone to post-surgical recovery with a small bandage on their scalp rather than a large suture line. We are proud of our technology&rsquo;s contribution to less-invasive brain surgery.&rdquo;</span></p></div> Older migraine sufferers may have more silent brain injury 2014-05-30T15:52:00Z 2014-05-30T15:52:00Z <div id="ImageMain90" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction90" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Older migraine sufferers may be more likely to have silent brain injury, according to research published in the American Heart Association&rsquo;s journal&nbsp;<em><a href="" target="_blank">Stroke</a>.</em></strong></span></p> </div><div id="Text190" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In a new study, people with a history of&nbsp;migraine headaches&nbsp;had double the odds of ischaemic&nbsp;silent brain infarction&nbsp;compared to people who said they did not have migraines. Silent brain infarction is a brain injury likely caused by a blood clot interrupting blood flow to brain tissue. Sometimes called &ldquo;silent strokes,&rdquo; these injuries are symptomless and are a risk factor&nbsp;for future strokes.</span></p> <p><br /><span style="font-size: 10pt;">Previous studies indicated migraine could be an important stroke risk factor for younger people.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;I do not believe migraine sufferers should worry, as the risk of&nbsp;ischemic stroke&nbsp;in people with migraine is considered small,&rdquo; says Teshamae Monteith, lead author of the study and assistant professor of clinical neurology and chief of the Headache Division at the University of Miami Miller School of Medicine, USA. &ldquo;However, those with migraine and vascular risk factors may want to pay even greater attention to lifestyle changes that can reduce stroke risk, such as exercising and eating a low-fat diet with plenty of fruits and vegetables.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">High blood pressure, another important stroke risk factor, was more common in those with migraine. But the association between migraine and silent brain infarction was also found in participants with normal blood pressure.</span></p> <p><br /><span style="font-size: 10pt;">Because Hispanics and African-Americans are at increased stroke risk, researchers from the Northern Manhattan Study (NOMAS) &ndash; a collaborative investigation between the University of Miami and Columbia University &ndash; studied a multi-ethnic group of older adults (41% men, average age 71) in New York City, USA. About 65% of participants were Hispanic. Comparing magnetic resonance imaging results between 104 people with a history of migraine and 442 without, they found:<br /><br /></span></p> <ul> <li><span style="font-size: 10pt;">A doubling of silent brain infarctions in those with migraine even after adjusting for other stroke risk factors;</span></li> <li><span style="font-size: 10pt;">No increase in the volume of white-matter hyperintensities (small blood vessel abnormalities) that have been associated with migraine in other studies;</span></li> <li><span style="font-size: 10pt;">Migraines with aura &mdash; changes in vision or other senses preceding the headache &mdash; wasn&rsquo;t common in participants and wasn&rsquo;t necessary for the association with silent cerebral infarctions.</span></li> </ul> <p><br /><span style="font-size: 10pt;">&ldquo;While the lesions appeared to be ischaemic, based on their radiographic description, further research is needed to confirm our findings,&rdquo; Monteith says.</span></p> <p><br /><span style="font-size: 10pt;">The research raises the question of whether preventive treatment to reduce the severity and number of migraines could reduce the risk of stroke or silent cerebral infarction.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We still don&rsquo;t know if treatment for migraines will have an impact on stroke risk reduction, but it may be a good idea to seek treatment from a migraine specialist if your headaches are out of control,&rdquo; Monteith says.</span></p></div> NICE recommends Lemtrada (alemtuzumab) 12mg IV for the treatment of active relapsing remitting multiple sclerosis 2014-05-30T15:32:00Z 2014-05-30T15:32:00Z <div id="ImageMain91" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction91" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending that Lemtradashould be reimbursed on the National Health Service (NHS), as an option for treating adults with active relapsing remitting multiple sclerosis, within its marketing authorisation.<a name="_ednref1"></a><a name="_Ref384996260"></a> Lemtradahas been shown to significantly reduce annualised relapse rates in both treatment-na&iuml;ve and treatment-experienced adult patients with active relapsing remitting multiple sclerosis versus an active comparator.</strong></span><a name="_ednref2"></a><a name="_Ref385422200"></a><a name="_ednref3"></a><a name="_Ref385422174"></a></p> </div><div id="Text191" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Lemtrada, a humanised monoclonal antibody therapy, is the first multiple sclerosis therapy to demonstrate superior reduction in the risk of disability accumulation in treatment-experienced people, when compared to subcutaneous interferon beta 1a (SC IFNB-1a).</span><br /> <br /><span style="font-size: 10pt;"> &ldquo;We are delighted that after many years in development, Lemtrada is now available on the NHS. Treatments which have the potential to improve the lives of those living with multiple sclerosis should be available to all who might benefit.&nbsp;Lemtrada offers an important additional treatment option which will be welcomed by the multiple sclerosis community,&rdquo; says Amy Bowen, director of Service Development at the Multiple Sclerosis Trust.Unlike other MS treatments currently available, Lemtrada is administered in two short treatment courses, one year apart<a name="_ednref4"></a><a name="_Ref386808635"></a>.</span></p></div> Teva and Active Biotech to continue with the development of Nerventra (Laquinimod) for MS following confirmation of CHMP opinion 2014-05-30T15:21:00Z 2014-05-30T15:21:00Z <div id="Introduction92" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Teva Pharmaceutical Industries and Active Biotech have announced that the Committee for Medicinal Products for Human Use (CHMP) confirmed its January 23, 2014 opinion to recommend against approval for the treatment of relapsing-remitting multiple sclerosis in the European Union at this time.</strong></span></p> </div><div id="Text192" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Both companies remain committed to the Nerventra&nbsp;(laquinimod) clinical development programme for multiple sclerosis and are focused on evaluating the CHMP feedback to determine potential next steps.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We are disappointed with the outcome of the re-examination and will be working with the EMA to make Nerventra available to multiple sclerosis patients in the EU,&rdquo; says Michael Hayden, president of Global R&amp;D and chief scientific officer. &ldquo;We believe Nerventra has a favourable risk-benefit profile and the potential to fulfil an unmet need for a treatment that decreases disability progression, and protects against brain volume loss, two important goals in the management of multiple sclerosis.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />To further confirm the benefits of Nerventra on disability progression, Teva is conducting the <a href=";rank=3" target="_blank"><strong>CONCERTO</strong></a> trial, the largest multiple sclerosis trial with disability progression as the primary endpoint. The ongoing CONCERTO trial is the third phase III study in relapsing-remitting multiple sclerosis and explores daily doses of Nerventra 0.6mg and 1.2mg. In addition, Teva is investigating the potential of Nerventra in progressive forms of multiple sclerosis. The first trial for this indication is planned to be initiated soon.</span></p></div> Symbis Surgical System named to 2014 Space Technology Hall of Fame 2014-05-30T15:05:00Z 2014-05-30T15:05:00Z <div id="ImageMain93" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction93" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>IMRIS has announced that the SYMBIS Surgical System - the second generation of the neuroArm / Symbis programme - is a 2014 inductee into the Space Technology Hall of Fame. The Space Foundation honour is directed at technologies originally developed for space exploration that are being transformed into products to help improve the quality of life on Earth.</strong></span></p> </div><div id="Text193" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;As an element of the future of neurosurgery, Symbis involves developing more precise minimally-invasive techniques with motion refinement where surgeons can reach small and eloquent areas to remove diseased tissue, and cause no damage to the adjacent delicate structures to protect the patient&rsquo;s quality of life and maximise the success of the surgery,&rdquo; says Meir Dahan, IMRIS chief technology officer and executive vice president of Research and Development.</span></p> <p><br /><span style="font-size: 10pt;">The Symbis programme originated in 2002 under the name neuroArm as a collaborative research concept primarily between the University of Calgary and MacDonald, Dettwiler and Associates (MDA) - the company which developed large robotic arms for the International Space Station and US space shuttle programmes. Design work initially focused on developing haptic (touch sensing) control mechanisms, special motors, semi-automated surgical tool exchange protocols, and communications technologies. The intent was to pair near real-time, high-resolution magnetic resonance (MR) and anatomical images with robotic arm manipulation technologies to provide neurosurgeons with image guidance, precision, accuracy and dexterity.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Where Symbis has come from and is heading to, represents collaborations of many interdisciplinary creative teams of engineers, scientists and surgeons. Our goal was to integrate the surgeon&rsquo;s skills and decision making with mechanised accuracy,&rdquo; says Garnette Sutherland, professor of neurosurgery at University of Calgary, who led the team which developed the original robot, neuroArm. &ldquo;This honour and research illustrates how the merging of human surgical experience with machines and computerised technology is driving neurosurgical advancement towards more minimalism and finer accuracy.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Symbis system now consists of two manipulator arms with eight degrees of freedom of movement on a mobile base and a remote workstation where a surgeon sits and is provided with a virtual environment that recreates the sight, sound and touch of surgery. The arms operate surgical tools only in conjunction with the surgeon&rsquo;s remote hand movements. (The Symbis Surgical System is not currently available for sale.)</span></p> <p><br /><span style="font-size: 10pt;">In 2008, the original neuroArm was first used by Sutherland to remove a brain tumour from a patient at Foothills Medical Centre in Calgary and since has been used 60 times for tumour and vascular malformation cases. IMRIS acquired the technology in 2010 to further develop it into an MR-compatible system that will one day allow the surgeon to do surgery using real time MR imaging in the bore of the magnet. IMRIS is currently working towards a commercialised second generation model integrated within the Visius Surgical Theatre with intraoperative MRI or CT.</span></p> <p><br /><span style="font-size: 10pt;">IMRIS chief executive officer and president Jay D Miller says, &ldquo;We are honoured by this award and recognise the pioneering leadership, experience and general support that was brought together to create this game changing tool. By finding ways to improve the vision and precision of surgery through these tools, we are working towards mitigating risks and improving the outcomes for neurosurgical patients and lower costs for the health care system.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Space Technology Hall of Fame inductees were recognised during a ceremony on May 22 in Colorado Springs, USA. The Hall of Fame was created in 1988 by the non-profit Space Foundation to increase public awareness of the benefits resulting from space exploration programmes and encourage further innovation. IMRIS, MDA, and the University of Calgary were inducted as organisations; and Sutherland was admitted as an individual.</span></p></div> Significant milestones set in world&apos;s most detailed brain imaging study to help unlock root causes of dementia 2014-05-29T12:47:00Z 2014-05-29T12:47:00Z <div id="ImageMain94" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction94" style="clear:both;"> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 11pt;"><strong><span style="font-family: Helvetica, sans-serif; color: #333333;">Having enlisted thousands of Britons and captured detailed information about their health and lifestyle, UK Biobank is now turning its attention to their brains<em>&mdash;</em>as part of the global effort to defeat dementia. Around 100,000 participants are expected to be part of the world&rsquo;s most comprehensive imaging project over the next five years, following the launch of a feasibility study.</span></strong></span></p> </div><div id="Text194" style="clear:both; text-align:left"><p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">The pilot phase of the programme has just been initiated and the first 50 participants have already been successfully scanned using advanced magnetic resonance imaging (MRI) technology from Siemens Healthcare. The study will capture images not only of their brains, but also their hearts and other organs in the quest to unlock understanding into the causes of dementia and diseases of middle to older age.</span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">Non-invasive brain scans of UK Biobank participants, now aged 44<em>&ndash;7</em>7, are being captured using Siemens medical imaging technology. Data from cognitive testing, a range of physical evaluations, DNA and health records are also being included in this project. By 2022 UK Biobank expects to have captured about 9,000 cases of Alzheimer&rsquo;s disease, due to the natural ageing of the UK Biobank participants. Combining such data is expected to create a huge health research resource, one of the largest in the world, for use by bona fide scientists anywhere in the world.</span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt;"><span class="xn-person"><span style="font-family: Helvetica, sans-serif; color: #333333;">Paul Matthews</span></span><span style="font-family: Helvetica, sans-serif; color: #333333;">, head of the Division of Brain Sciences at Imperial College,<span class="apple-converted-space">&nbsp;</span><span class="xn-location">London</span>, UK, &nbsp;who led the experts that developed the UK Biobank imaging plans, states, &ldquo;Development of treatments to slow or stop dementia is the greatest healthcare challenge facing the developed world. New clues suggest that we need to broaden our research focus on the brain in the context of the whole body and the way it changes with age to find the triggers for Alzheimer&rsquo;s and vascular dementia. We need to study people before and in the earliest stages to confirm mechanisms and test new drugs. UK Biobank will provide an unrivalled resource for these studies with the addition of advanced brain and body imaging to its rich clinical, cognitive, soluble biomarker and genetic dataset. This ambitious programme promises to massively accelerate both public and private therapeutics research for dementia.&rdquo;</span></span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">He adds, &ldquo;Commitment by the Medical Research Council to fund the UK Biobank imaging feasibility study is a shot in the arm to dementia research<em>&mdash;</em>and the research community will work together to put this tool to best use.&rdquo;</span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt;"><span class="xn-person"><span style="font-family: Helvetica, sans-serif; color: #333333;">Craig Buckley</span></span><span style="font-family: Helvetica, sans-serif; color: #333333;">, Head of Research and Scientific Collaborations at Siemens Healthcare GB&amp;I says: &ldquo;With a growing ageing population and diagnosed dementia rates on the rise, the race is on to fully characterise the disease. With the help of imaging, we hope to be able to slow the pace, prevent and even cure these syndromes. To date, dementia research has faced great challenges, with limited access to large scale, standardised brain data to help with understanding of the disease. With increasing support from government bodies, research institutions such as UK Biobank can now access cutting-edge imaging technology to ensure every scan is consistent for each participant, helping to create a new wave of data that is more accurate and insightful than ever before.&rdquo;</span></span></p> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt; font-family: Helvetica, sans-serif; color: #333333;">At the end of 2013, governments of the G8 countries turned their attention to dementia research, committing more funding to source better treatments and diagnosis tools for the 800,000 people living with dementia in the UK. It is believed delaying the onset of dementia by five years would reduce deaths dramatically. UK Biobank has been recognised as a key support tool, with support received from UK governments, the Wellcome Trust, Medical Research Council and British Heart Foundation.</span></p></div> FDA clears SpringTMS migraine treatment device 2014-05-29T10:34:00Z 2014-05-29T10:34:00Z <div id="ImageMain95" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction95" style="clear:both;"> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 11pt;"><strong><span style="font-family: Helvetica, sans-serif; color: #333333;">eNeura has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its SpringTMS migraine treatment device. SpringTMS is the first medical device available to patients in<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">the USA</span></span><span class="apple-converted-space">&nbsp;</span>for the acute treatment of pain associated with migraine headache with aura.</span></strong></span></p> </div><div id="Text195" style="clear:both; text-align:left"><p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; color: #333333; font-size: 10pt;">SpringTMS is a prescription-only device that utilises single-pulse transcranial magnetic stimulation (sTMS) to induce very mild electrical currents that can depolarise neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine. The non-invasive, proprietary device is designed for patient use.&nbsp;To treat, the device is placed at the back of the head where the push of a button generates a focused magnetic pulse with the intent to eliminate the pain of a migraine headache.</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; color: #333333; font-size: 10pt;"><br />eNeura&rsquo;s first-generation transcranial magnetic stimulation device&nbsp;(Cerena) received FDA clearance in<span style="box-sizing: border-box;"> <span class="xn-chron">December 2013</span></span>. The FDA reviewed a double-blind, placebo-controlled, randomised clinical study of 201 patients. The study, which took place in 18 US centres, showed that nearly 38% of subjects who used sTMS when they had migraine headache pain were pain-free two hours after using the device compared to approximately 17% of patients in the control group. After 24 hours, approximately 34% of the sTMS users were pain-free compared to only 10% in the control group. The treatment did not produce any device-related serious adverse events.</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; color: #333333; font-size: 10pt;"><br />SpringTMS provides the same therapy as the Cerena device but offers improved portability. The initial US availability of SpringTMS will be launched at a select number of US specialist headache centres.</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: Helvetica, sans-serif; color: #333333; font-size: 10pt;"><br />SpringTMS is currently CE marked in<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Europe</span></span><span class="apple-converted-space">&nbsp;</span>and is available to patients in the<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">UK&nbsp;</span></span>for acute treatment of migraine. The UK National Institute for Health and Care Excellence (NICE) recently published positive guidance recommending TMS for acute and preventative treatment of migraine for patients in the UK.</span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt;"><span class="xn-person"><span style="font-family: Helvetica, sans-serif; color: #333333;"><br />Peter Goadsby</span></span><span style="font-family: Helvetica, sans-serif; color: #333333;">, chair of the British Association for the Study of Headache, and director of the National Headache Centre at King&rsquo;s College Hospital in<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">London</span></span>, says, &ldquo;The use of single pulse transcranial magnetic stimulation has given hundreds&nbsp;of patients in the UK relief from debilitating migraine without troublesome side effects. I&nbsp;am sure&nbsp;many migraine sufferers in the USA will also experience real benefits from this unique technology.&rdquo;</span></span></p> <p style="line-height: 15.0pt; background: white; box-sizing: border-box; word-wrap: break-word; orphans: auto; text-align: start; widows: auto; -webkit-text-stroke-width: 0px; word-spacing: 0px; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 10pt;"><span class="xn-person"><span style="font-family: Helvetica, sans-serif; color: #333333;"><br />Richard B Lipton</span> p</span><span style="font-family: Helvetica, sans-serif; color: #333333;">rofessor of neurology and director of the Montefiore Headache Center at the Albert Einstein College of Medicine, and lead investigator on the Cerena pivotal efficacy study comments, &ldquo;Many patients with migraine do not get adequate relief from available medications, prefer not to take them and sometimes overuse them.&nbsp;There is a great need for an effective drug-free acute treatment option for these patients. The low risk of side effects and the ease of use of the SpringTMS make it a viable option for many of my patients.&nbsp;I look forward to participating in the post-market observational study for this innovative technology.&rdquo;&nbsp;</span></span></p></div> GE Healthcare and CorTechs Labs announce strategic agreement to co-market NeuroQuant 2014-05-29T10:14:00Z 2014-05-29T10:14:00Z <div id="ImageMain96" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction96" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>At the joint meeting of the <a href="" target="_blank">International Society of Magnetic Resonance in Medicine (ISMRM) and the European Society of Magnetic Resonance in Medicine and Biology (ESMRMB)</a>, GE Healthcare and CorTechs Labs announced the signing of a strategic joint-marketing agreement. The companies will collaborate to co-market a powerful MRI scanning solution combined with NeuroQuant, CorTechs Labs&rsquo; MRI post-processing application.</strong></span></p> </div><div id="Text196" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">NeuroQuant enables the acquisition of volumetric brain image data and automatically conducts accurate and consistent measurements of cortical and subcortical volumes targeted at identifying evidence of neurodegeneration. This innovative solution will provide neurologists and radiologists with objective support for their clinical impression.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Accurate measurement of volumes of different parts of the brain may be a useful aid in the diagnosis of neurodegenerative diseases such as Alzheimer&rsquo;s, multiple sclerosis and traumatic brain injury,&rdquo; says Chris Airriess, chief technology officer, CorTechs Labs. &ldquo;Volume changes in certain brain structures have been linked in the literature to early indications of such conditions where more traditional diagnoses lack detection sensitivity.&rdquo; NeuroQuant does this in an automated fashion, without user intervention, and is the only 510(k) approved software for this application.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;CorTechs Labs is a pioneer and a trendsetter in the area of software for the aid of brain diagnostics and is widely used in clinical practices worldwide,&rdquo; says Baldev Ahluwalia, premium segment manager at GE Healthcare, MRI. &ldquo;We at GE Healthcare look forward to collaborating with CorTechs Labs, benefitting from their innovative approach to providing the highly-desired quantitative brain volumetric information with NeuroQuant.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">"We are pleased to expand our relationship with GE Healthcare. With a leading global presence in advanced MRI scanning solutions, GE Healthcare is a terrific collaborator providing complementary products and services,&rdquo; says Guri Stark, CorTechs Labs&rsquo; chief executive officer. &ldquo;We look forward to working with GE Healthcare to empower clinicians with objective quantitative data, while continuing NeuroQuant&rsquo;s growth momentum. In turn, this furthers our vision to establish NeuroQuant as the standard measurement solution for all brain disorders, including Alzheimer&rsquo;s disease, epilepsy, multiple sclerosis and traumatic brain injury.&rdquo;</span></p></div> Inovio Pharmaceuticals acquires early stage DNA therapies to treat Alzheimer&apos;s and multiple sclerosis 2014-05-29T10:03:00Z 2014-05-29T10:03:00Z <div id="ImageMain97" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction97" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Inovio Pharmaceuticals has announced that it has acquired worldwide rights (excluding&nbsp;China) for early preclinical therapies addressing Alzheimer&rsquo;s disease and multiple sclerosis based on the academic research of Bin Wang, a professor at Fudan University&rsquo;s Shanghai Medical College. Wang is a pioneer in the field of DNA therapies, having worked closely with&nbsp;David Weiner&nbsp;at the&nbsp;University of Pennsylvania, USA. Wang was the primary author on some of the earliest DNA vaccine papers and patents. In consideration for these rights, Inovio will make clinical and regulatory milestone payments to the University.</strong></span></p> </div><div id="Text197" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">These newly licensed technologies are based on patent-protected and published discoveries from Wang and his collaborator, who found a novel way to generate inducible regulatory T cells, or iTreg. iTreg cells are involved in shutting down immune responses after they have successfully eliminated invading organisms, and also in preventing autoimmunity or inflammatory diseases. In multiple published preclinical studies, this approach generated CD25-iTreg in an antigen-specific manner. These novel approaches could be used to develop therapies targeting major inflammatory diseases like multiple sclerosis and may be used to treat Alzheimer&rsquo;s disease.</span></p> <p><br /><span style="font-size: 10pt;">J Joseph Kim, Inovio&rsquo;s president and chief executive officer, said, &ldquo;Acquiring these early-stage technologies is just another step in our ultimate goal of controlling the immune system to fight diseases in a more safe and effective manner using Inovio&rsquo;s immune engineering platform. Our therapeutic cancer vaccines in the clinic are designed to properly activate and direct T cells to kill cancer cells. These new candidates are designed to do the opposite by shutting down unwanted and aberrant T cell responses that cause autoimmune and inflammatory diseases. These new technologies give us the potential to go after these important disease targets.&rdquo;</span></p></div> Neurotrope collaborates with Paul Wender and Stanford University on bryostatin analogues 2014-05-21T09:48:00Z 2014-05-21T09:48:00Z <div id="Introduction98" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neurotrope announced today that it has signed an agreement with&nbsp;Stanford University&nbsp;to study and, along with Paul Wender, investigate certain analogs of bryostatin, referred to as "bryologs", as potential clinical candidates for the treatment of various neurological disorders.&nbsp;</strong></span></p> </div><div id="Text198" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This collaboration is framed by a license agreement forged between&nbsp;Stanford University&nbsp;and Neurotrope, which provides the company with exclusive rights to make, use or sell certain bryologs for commercial application in therapeutic applications for central nervous system disorders, lysosomal storage diseases, stroke, cardioprotection and traumatic brain injury.</span><br /><br /></p> <p><span style="font-size: 10pt;">Bryostatin is Neurotrope&rsquo;s phase II clinical candidate currently being investigated for the treatment of Alzheimer&rsquo;s disease.&nbsp; Bryostatin potently activates the enzyme PKCepsilon (PKCe), and in preclinical&nbsp;<em>in vivo&nbsp;</em>models this effect has been shown to play a role in slowing or reversing several neurodegenerative disease processes, according to a press release.</span><br /><br /></p> <p><span style="font-size: 10pt;">Bryostatin is a natural product produced by a marine microorganism called&nbsp;<em>Bugula neritina&nbsp;</em>and is<em>&nbsp;</em>isolated from biomass harvested from the ocean.&nbsp;Several total syntheses of this complex product have been achieved in recent years in various academic chemistry laboratories, and these approaches represent an alternative source of this drug.</span><br /><br /></p> <p><span style="font-size: 10pt;">Wender&rsquo;s laboratory reports that it has synthesised a large family<strong><em>&nbsp;</em></strong>of bryologs over a number of years as part of a research programme to define the essential pharmacophore (molecular features) critical to bryostatin&rsquo;s potent biological activity. The bryologs are easier to produce than bryostatin due to their less complex chemical structures. They represent a rich collection of potential drug candidates, some of which are expected to be advanced to clinical trials by Neurotrope for the treatment of several neurodegenerative diseases such as ischaemic stroke, Fragile X syndrome, traumatic brain injury and Alzheimer&rsquo;s disease.</span></p></div> Barnes-Jewish Hospital neurosurgeons treat 1,000th patient using VISIUS iMRI 2014-05-20T12:57:00Z 2014-05-20T12:57:00Z <div id="ImageMain99" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction99" style="clear:both;"> <p><strong><span style="font-size: 11pt;">IMRIS has announced that Barnes-Jewish Hospital in St Louis is the first US hospital to use VISIUS&nbsp;iMRI for more than 1,000 procedures. This clinical experience and published evidence by the neurosurgical team has shown that intraoperative MRI is an effective tool for improving results and outcomes for patients undergoing brain surgery.</span></strong></p> </div><div id="Text199" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">"Using MR during procedures instead of after, we can truly measure what we have accomplished and go back and resect more tumour before actually completing the surgery. We cannot see this tumour without iMRI. Our published experience has shown this leads to better long-term survival and quality of life," says Michael Chicoine, Barnes-Jewish neurosurgeon and associate professor of neurological surgery at Washington University School of Medicine, USA. "While the iMR is among the tools we use, the patients are the real beneficiaries as we limit the risks for returning to surgery."</span><br /><br /><span style="font-size: 10pt;">Installed in 2008, the VISIUS Surgical Theatre is a three-room suite where a high-field MR travels between two hybrid operating rooms using ceiling-mounted rails with a third room in the middle for storing the scanner when not in use. The high-quality MR imaging provides surgeons with on-demand access to real-time updated image detail during the procedures without moving the patient, according to the company.</span><br /><br /><span style="font-size: 10pt;">IMRIS CEO and president Jay D Miller says: "This milestone sets the neurosurgical team at Barnes-Jewish and Washington University apart in their pioneering leadership and experience. Their expertise and that of other VISIUS installations is moving iMR towards the standard of care for certain tumours and greater utilisation for other neurosurgical procedures."</span><br /><br /><span style="font-size: 10pt;">IMRIS supports on-going studies and research regarding the use and benefits of ceiling-mounted iMRI through an expanding Washington University School of Medicine multicentre neurosurgical database called I-MiND (IMRIS Multicentre iMRI Neurosurgery Database) which includes a number of hospitals</span>.</p></div> Keystone heart raises US$14m in series B funding for cerebral protection devices 2014-05-19T13:19:00Z 2014-05-19T13:19:00Z <div id="ImageMain100" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction100" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Keystone Heart has raised US$14 million in series B funding for cerebral protection devices.&nbsp;By protecting all brain territories, the TriGuard cerebral protection device is designed to minimise the risk of cerebral damage during transcatheter aortic valve implantation (TAVI) and other cardiovascular procedures.</strong></span></p> </div><div id="Text1100" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Keystone Heart&rsquo;s TriGuard, according to the company, is the only cerebral protection device specifically designed to provide full coverage to all aortic arch take-offs. By protecting all brain territories, the TriGuard cerebral protection device is designed to minimise the risk of cerebral damage during transcatheter aortic valve implantation (TAVI) and other cardiovascular procedures.</span><br /><br /><span style="font-size: 10pt;">The current round of financing is expected to be dedicated to conducting a European multicentre, randomised clinical trial during TAVI procedures, as well as a planned Food and Drug Administration (FDA) investigational device exemption (IDE) study. According to the company, these studies aim to enable further assessment of the efficacy and performance of the TriGuard and are expected to generate additional clinical data to support the TriGuard commercialisation globally. Keystone Heart is planning additional studies to leverage the TriGuard product pipeline in TAVI and other cardiovascular indications.</span><br /><br /><span style="font-size: 10pt;">Hank Hauser, formerly vice president clinical affairs at Vessix Vascular, has recently joined Keystone Heart as vice president clinical operations, to support these expanding clinical activities.</span><br /><br /><span style="font-size: 10pt;"><a href=";rank=1" target="_blank">DEFELCT I</a> clinical data, presented at EuroPCR 2013 (May; Paris, France), demonstrated a significant reduction of over 60% of new brain lesion volume during protected TAVI procedures using TriGuard, compared with historical data on unprotected TAVI procedures. <a href=";rank=1" target="_blank">DEFLECT III</a>, a multicentre, randomised clinical trial, conducted in up to 12 centres across Europe and Israel, is currently enrolling patients undergoing TAVI procedures, to evaluate this critical effect further.</span><br /><br /><span style="font-size: 10pt;">"When performing TAVI procedures, we should provide embolic cerebral protection to protect the brain from insult. I strongly believe that TriGuard makes a difference" says Joachim Schofer, head of Universitares Herzzentrum in Hamburg, Germany, one of the leading investigators participating in this study.</span><br /><br /><span style="font-size: 10pt;">TriGuard is not commerically available in the USA.</span></p></div>