Latest News - Neuro News Affino Atom Generator BIBA Medical Ltd 2014-04-24T18:27:58Z Legal safeguards needed for brain-boosting devices 2014-04-24T15:32:00Z 2014-04-24T15:32:00Z <div id="ImageMain1" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction1" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Researchers from the Oxford Martin School, University of Oxford, UK, are calling for the regulation of a new breed of devices designed to enhance the brain&rsquo;s performance. &nbsp;According to Oxford Martin School, these devices, because of European legislation, only receive basic product safety requirements.</span></strong></p> </div><div id="Text11" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Cognitive enhancement devices offer the tantalising prospect of potentially making users&rsquo; brains work faster, more effectively, and more creatively, and are now being marketed for gaming and education. But current European legislation subjects these devices to nothing more than basic product safety requirements, despite them directly modifying the electrical activity of the brain,&rdquo; it says in an Oxford Martin School press release.</span><br /><br /><span style="font-size: 10pt;">A new Oxford Martin policy paper proposes a regulatory model to help oversee this expanding industry. Authored by Hannah Maslen, Thomas Douglas, Roi Cohen Kadosh, Neil Levy and Julian Savulescu, &ldquo;Mind Machines: the regulation of cognitive enhancement devices&rdquo; provides a comprehensive overview of the types of devices available, assesses the regulatory weaknesses, and provides a practical pathway to designing a regulatory model for cognitive enhancement devices.</span><br /><br /><span style="font-size: 10pt;">According to the release, in the European Union these products are not covered by the Medical Devices Directive because they are neither diagnostic nor therapeutic.</span><br /><br /><span style="font-size: 10pt;">It states in the press release: &ldquo;While the same kinds of devices are being trialled by scientists to treat conditions such as depression or Parkinson&rsquo;s disease, when the manufacturer makes no claim to therapeutic effect&mdash; either treatment or diagnosis&mdash;they are unregulated, with no system in place to guarantee their safety. With the market for enhancement technologies expanding and devices already crossing international borders, controlling which products are approved for sale is a global issue, potentially requiring international regulatory harmonisation.&rdquo;</span><br /><br /><span style="font-size: 10pt;">Julian Savulescu, director of the Institute for Science and Ethics within the Oxford Martin School, comments: &ldquo;Cognitive enhancement devices open up a range of possibilities in increasing cognitive abilities, but are not risk free. This paper&rsquo;s proposed regulatory model is directed at both policymakers and manufacturers, and seeks to ensure that consumers can be confident in their choices when purchasing a device.&rdquo;</span><br /><br /><span style="font-size: 10pt;">The commercial market for these devices is as yet unmeasured, with no sales figures available. The paper&rsquo;s lead author Hannah Maslen, research fellow in Ethics on the Oxford Martin School Programme on Mind and Machine, says that this makes it the right time to act: &ldquo;The market for these devices is still in its infancy, so now is the right time to address gaps in regulation to ensure their safety.&rdquo;</span><br /><br /><span style="font-size: 10pt;">The paper&rsquo;s authors recommend that:</span></p> <ul> <li><span style="font-size: 10pt;">Cognitive enhancement devices should be regulated in the European Union Medical Devices Directive, as they possess similar mechanisms and risk profiles to some medical devices. This approach would allow for efficiency in legislation, with a precedent already set by the inclusion in the directive of some non-medical (cosmetic) implantable and invasive devices</span></li> <li><span style="font-size: 10pt;">High-risk devices must be prohibited; comprehensive and objective information from the manufacturers about mechanisms, safe use and risks and benefits must be provided for moderate-risk devices; and low-risk devices should be exempt from continued regulatory evaluation</span></li> <li><span style="font-size: 10pt;">This model could be adopted in other jurisdictions across the world and, given the online market for these devices, international regulatory harmonisation is potentially required</span></li> <li><span style="font-size: 10pt;">Criminal sanctions should be applied if cognitive enhancement devices intended for use on adults are used on children by individuals lacking adequate training</span></li> <li><span style="font-size: 10pt;">Device manufacturers must exercise best practice in anticipation of regulatory oversight.</span></li> </ul></div> Tampa General Hospital launches advanced intraoperative MRI use with first cases 2014-04-24T15:17:00Z 2014-04-24T15:17:00Z <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><strong><span style="font-size: 11pt;">IMRIS has announced that a University of South Florida neurosurgical team at Tampa General Hospital (TGH), USA, completed initial cases last week using its recently installed VISIUS intraoperative MRI. The first case was a right parietal high-grade glioma.</span></strong></p> </div><div id="Text12" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We can now see how a patient&rsquo;s surgery is going and affect the outcome rather than complete the surgery and accept the outcome,&rdquo; says Harry van Loveren, TGH neurosurgeon, interim dean of the University of South Florida Morsani College of Medicine, USA (also chair of the college&rsquo;s department of neurosurgery and brain repair). &ldquo;Having this level of imaging available during complicated neurosurgeries, we anticipate improving surgical results and reducing the number of re-operations.&rdquo;</span><br /><br /><span style="font-size: 10pt;">The two-room VISIUS Surgical Theatre at TGH features a high-field MR that travels to the patient using ceiling-mounted rails, it says in company press release. The fully-integrated suite allows the scanner to move between an operating room and a diagnostic room, providing on-demand access to high resolution MR images&mdash;before, during and after procedures without moving the patient from the OR table.</span></p></div> AdvaStim enters neuromodulation device market 2014-04-24T11:25:00Z 2014-04-24T11:25:00Z <div id="Introduction3" style="clear:both;"> <p><strong><span style="font-size: 11pt;">AdvaStim has announced today that it has entered the research and development market with a new hardware/software solution for neuromodulation therapy developers.</span></strong></p> </div><div id="Text13" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;AdvaStim was formed to address the multi-billion-dollar neurostimulation market with a hardware and software platform to help device companies and clinician researchers develop the next generation of implantable therapeutics,&rdquo; says Laurence Derose, founder of AdvaStim.</span><br /><br /><span style="font-size: 10pt;">&ldquo;Our Implantable Pulse Generator technology was designed to accommodate a variety of existing and emerging clinical indications,&rdquo; continues Derose. &ldquo;It offers developers complete independent control over waveform current, duration, rate and phase characteristics. The system architecture is modular, providing a building-block approach for easy customisation.&rdquo;</span><br /><br /><span style="font-size: 10pt;">AdvaStim&rsquo;s pulse generator technology is based on the company&rsquo;s VLSI-based ASICore chip architecture, along with its ASIControl embedded software. This combination allows for a broad range of stimulation algorithms that can deliver variable penetration of charge to a volume of neural tissue, it says in a company release.</span><br /><br /><span style="font-size: 10pt;">AdvaStim&rsquo;s ASICore chip architecture allows for multi-channel switching, user-defined output energy algorithms and external sensor data. According to the company, its compact form factor can help enable a new generation of smaller, more flexible and customisable implantable pulse generators.</span><br /><br /><span style="font-size: 10pt;">In the press release it says that the AdvaStim&rsquo;s ASIControl embedded software gives therapy developers an enhanced range of output energy parameters. It controls modulation of current amplitude and pulse duration, and allows for multi-channel delivery of simultaneous, sequential or independent pulse rates.</span><br /><br /><span style="font-size: 10pt;">&ldquo;AdvaStim&rsquo;s technology gives therapy developers new capabilities to shape the stimulation field and provides tools to allow them to explore the issue of neural adaptation,&rdquo; states Barry Yomtov, chief technology officer and co-founder of AdvaStim. &ldquo;Our technology gives developers a cost-effective platform for future growth and a faster track to prototype new therapy devices.&rdquo;</span></p></div> Lpath and Walter Reed Army Institute for Research begin efficacy study using Lpathomab in traumatic brain injury models 2014-04-24T11:11:00Z 2014-04-24T11:11:00Z <div id="Introduction4" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Lpath and scientists from the Center for Military Psychiatry and Neuroscience, Walter Reed Army Institute of Research (WRAIR), USA, have initiated a study on the use of Lpathomab, an antibody to lysophosphatidic acid (LPA), in the treatment of brain injury induced by blast overpressure.</span></strong></p> </div><div id="Text14" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The investigators at WRAIR are Joseph Long, a US Army civilian and chief, Blast Induced Neurotrauma Branch Center for Military Psychiatry and Neuroscience at WRAIR, and Peetthambaran Arun, from Clinical RM (both USA).</span><br /><br /><span style="font-size: 10pt;">According to a press release, the use of improvised explosive devices and hand-held grenades in recent wars has increased the incidence of blast traumatic brain injury, a major cause of disability among service members. The prevalence of concussions in soldiers returning from Iraq or Afghanistan has been estimated at approximately 19.6%, and accounts for 150,000 casualties. There are currently no US Food and Drug&nbsp;Administration-approved drug treatments for any form of traumatic brain injury, it states in the release.</span><br /><br /><span style="font-size: 10pt;">Lpath and collaborators recently published work showing that Lpathomab reverses much of the damage caused by trauma to the nervous system in a controlled cortical-impact model of traumatic brain injury in mice (<a href="" target="_blank"><em>Journal of Neuroinflammation</em></a>, volume 11(1):37). The Lpath-WRAIR collaboration is expected to extend those studies to determine if Lpathomab can be used to reduce the size of a blast brain injury and to improve functional behavioural outcomes in experimental animal models.</span><br /><br /><span style="font-size: 10pt;">Lpath is currently conducting IND-enabling studies for Lpathomab and intends to enter phase I clinical trials in early 2015 for neuropathic pain and neurotrauma.</span></p></div> Therapies based on newly-discovered GAIM could combat neurodegenerative disorders 2014-04-23T12:57:00Z 2014-04-23T12:57:00Z <div id="ImageMain5" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction5" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers from NeuroPhage Pharmaceuticals have engineered a series of molecules with the potential to treat most neurodegenerative diseases that are characterised by misfolded proteins, such as Alzheimer&rsquo;s, Parkinson&rsquo;s and Huntington&rsquo;s diseases, according to a press release.&nbsp;</strong></span></p> </div><div id="Text15" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">This novel and &ldquo;revolutionary&rdquo; approach was published online in the <a href="" target="_blank"><em>Journal of Molecular Biology</em></a>. The publication, &ldquo;A bacteriophage capsid protein provides a general amyloid interaction motif (GAIM) that binds and remodels misfolded protein assemblies,&rdquo; was authored by Rajaraman Krishnan <em>et al</em>.</span><br /><br /><span style="font-size: 10pt;">NeuroPhage says these molecules are based on a general amyloid interaction motif, or GAIM, which recognises a characteristic common to many toxic, misfolded proteins, not just one type of misfolded protein.</span><br /><br /><span style="font-size: 10pt;">Researchers used an array of techniques, including X-ray fibre diffraction and nuclear magnetic resonance spectroscopy, to demonstrate the activities of GAIM. They discovered that GAIM effectively binds to multiple types of misfolded proteins during their formation in such a way that prevents new toxic protein aggregates from forming. In addition, upon incubating GAIM with various misfolded proteins, the researchers observed that GAIM disrupted these assemblies of misfolded proteins by causing a conformational change in their structures. This structural change could enable the body&rsquo;s natural disposal mechanism to recognize and clear the misfolded proteins, which in theory, would enable the brain to return to a more normal state. The ability to destabilise pre-existing aggregates of multiple types of misfolded proteins is unique in the field, it says in the release.</span><br /><br /><span style="font-size: 10pt;">It also says in the press release that this provides a number of therapeutic targets, so that different pathologies, such as amyloid beta plaques, tau tangles and alpha-synuclein Lewy bodies, can be addressed simultaneously with a single drug candidate. It has been shown that the GAIM molecules can not only prevent the formation of new toxic protein aggregates but can also clear existing aggregates in the form of both soluble oligomers and insoluble fibres, such as plaques and tangles.</span><br /><br /><span style="font-size: 10pt;">&ldquo;Symptoms of neurodegenerative diseases often appear well after the troublesome aggregates have begun to accumulate in the brain. By then, therapies that only target newly forming aggregates are likely to only slow the progression of the disease and are believed to be too late once the aggregates are formed,&rdquo; says Gregory A Petsko, professor of Neurology at Weill Cornell Medical College, New York City, USA and Tauber professor of Biochemistry and Chemistry, Emeritus, at Brandeis University in Waltham, USA. &ldquo;Therapies based on GAIM would represent a completely new paradigm in the treatment of many neurodegenerative diseases with their potential to ameliorate existing symptoms and prevent disease progression. The hope is this will eventually lead to a real treatment for Alzheimer&rsquo;s disease, but for now, the science behind it is quite compelling.&rdquo;</span><br /><br /><span style="font-size: 10pt;">Richard Fisher, chief scientific officer at NeuroPhage adds: &ldquo;GAIM has the potential to provide a more robust response than previous therapies because it enables the simultaneous targeting of multiple pathologies in a single disease.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">The discovery of GAIM has led to the creation of NeuroPhage&rsquo;s lead candidate, NPT088, which is the GAIM motif fused to a portion of a human antibody, the company say. The result is a potential therapeutic that can be easily delivered to patients. NeuroPhage has accumulated preclinical data on this candidate, demonstrating its efficacy across disease models of Alzheimer&rsquo;s, Parkinson&rsquo;s and related diseases characterised by aggregation of the tau protein. NeuroPhage expects that NPT088 will be ready for human studies in late 2015.</span><br /><br /><span style="font-size: 10pt;">&ldquo;With recent advances in imaging agents for beta-amyloid and tau in Alzheimer&rsquo;s disease, we believe we should be able to demonstrate clinical proof of mechanism in a phase 1b study with NPT088,&rdquo; states Jonathan Solomon, CEO at NeuroPhage. &ldquo;If successful, we would then have the opportunity to pursue many therapeutic options in several neurodegenerative diseases of protein aggregation.&rdquo;</span></p></div> Functional brain imaging reliably predicts which vegetative patients have potential to recover consciousness 2014-04-22T11:27:00Z 2014-04-22T11:27:00Z <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><strong><span style="font-size: 11pt;">A functional brain imaging technique, positron emission tomography (PET), is a promising tool for determining which severely brain damaged individuals in vegetative states have the potential to recover consciousness, according to new research published in <a href="" target="_blank"><em>The Lancet</em></a>.</span></strong></p> </div><div id="Text16" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">It is the first time that researchers have tested the diagnostic accuracy of functional brain imaging techniques in clinical practice, according to a press release.</span><br /><br /><span style="font-size: 10pt;">&ldquo;Our findings suggest that PET imaging can reveal cognitive processes that are not visible through traditional bedside tests and could substantially complement standard behavioural assessments to identify unresponsive or &lsquo;vegetative&rsquo; patients who have the potential for long-term recovery&rdquo;, says study leader Steven Laureys from the University of Li&eacute;ge in Belgium.</span><br /><br /><span style="font-size: 10pt;">It says in the press release that in severely brain-damaged individuals, judging the level of consciousness has proved challenging. Traditionally, bedside clinical examinations have been used to decide whether patients are in a minimally conscious state, in which there is some evidence of awareness and response to stimuli, or are in a vegetative state also known as unresponsive wakefulness syndrome, where there is neither, and the chance of recovery is much lower. Up to 40% of patients are misdiagnosed using these examinations, according to the release.</span><br /><br /><span style="font-size: 10pt;">&ldquo;In patients with substantial cerebral oedema, prediction of outcome on the basis of standard clinical examination and structural brain imaging is probably little better than flipping a coin,&rdquo; writes Jamie Sleigh from the University of Auckland, New Zealand, and Catherine Warnaby from the University of Oxford, UK, in an associated commentary.</span><br /><br /><span style="font-size: 10pt;">The study assessed whether two new functional brain imaging techniques&mdash;PET with the imaging agent fluorodeoxyglucose (FDG) and functional MRI (fMRI) during mental imagery tasks&mdash;could distinguish between vegetative and minimally conscious state in 126 patients with severe brain injury (81 in a minimally conscious state, 41 ina vegetative state and four with locked-in syndrome&mdash;a behaviourally unresponsive but conscious control group) referred to the University Hospital of Li&eacute;ge from across Europe. The researchers then compared their results with the well-established standardised Coma Recovery Scale&ndash;Revised (CSR-R) behavioural test, considered the most validated and sensitive method for discriminating very low awareness.</span><br /><br /><span style="font-size: 10pt;">Overall, FDG-PET was better than fMRI in distinguishing conscious from unconscious patients. Mental imagery fMRI was less sensitive at diagnosis of a minimally conscious state than FDG-PET (45% vs. 93%), and had less agreement with behavioural CRS-R scores than FDG-PET (63% vs. 85%). FDG-PET was about 74% accurate in predicting the extent of recovery within the next year, compared with 56% for fMRI.</span><br /><br /><span style="font-size: 10pt;">Importantly, a third of the 36 patients diagnosed as behaviourally unresponsive on the CSR-R test who were scanned with FDG-PET showed brain activity consistent with the presence of some consciousness. Nine patients in this group subsequently recovered a reasonable level of consciousness.</span><br /><br /><span style="font-size: 10pt;">According to Laureys: &ldquo;We confirm that a small but substantial proportion of behaviourally unresponsive patients retain brain activity compatible with awareness. Repeated testing with the CRS&ndash;R complemented with a cerebral FDG-PET examination provides a simple and reliable diagnostic tool with high sensitivity towards unresponsive but aware patients. fMRI during mental tasks might complement the assessment with information about preserved cognitive capability, but should not be the main or sole diagnostic imaging method.&rdquo;</span><br /><br /><span style="font-size: 10pt;">The authors point out that the study was done in a specialist unit focusing on the diagnostic neuroimaging of disorders of consciousness and therefore roll out might be more challenging in less specialist units.</span><br /><br /><span style="font-size: 10pt;">Commenting on the study Jamie Sleigh and Catherine Warnaby add: &ldquo;From these data, it would be hard to sustain a confident diagnosis of unresponsive wakefulness syndrome solely on behavioural grounds, without PET imaging for confirmation [&hellip;] [This] work serves as a signpost for future studies. Functional brain imaging is expensive and technically challenging, but it will almost certainly become cheaper and easier. In the future, we will probably look back in amazement at how we were ever able to practise without it.&rdquo;</span></p></div> RegeneRx receives notice of allowance for US patent for treatment of stroke 2014-04-22T11:08:00Z 2014-04-22T11:08:00Z <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><strong><span style="font-size: 11pt;">RegeneRx Biopharmaceuticals has announced that it has received a notice of allowance for a second US patent for treating central nervous system injuries and disorders using Thymosin beta 4 (T&beta;4) to regenerate damaged tissue.&nbsp;</span></strong></p> </div><div id="Text17" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In this case, the patent will be for the treatment of patients suffering a stroke. Researchers at the Henry Ford Hospital in Detroit, USA, discovered T&beta;4&rsquo;s effects in animal studies performed under a Material Transfer Agreement between the Institution and RegeneRx.</span><br /><br /><span style="font-size: 10pt;">According to a press release, RegeneRx has received a license to the intellectual property. The patent will expire in 2026.</span></p></div> Study reinforces value of high-field iMRI in brain tumour resection 2014-04-22T10:57:00Z 2014-04-22T10:57:00Z <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><strong><span style="font-size: 11pt;">IMRIS has announced that a study published in the journal <a href=""><em>Neurosurgery </em></a>by the neurosurgical team at Cleveland Clinic (USA) adds to growing clinical evidence which validates use of high-field intraoperative MRI (iMRI) as an effective tool for maximising the amount of surgical resection of gliomas (brain tumours).&nbsp;</span></strong></p> </div><div id="Text18" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Conducted using an IMRIS VISIUS Surgical Theatre, the study retrospectively reviewed use of high-field 1.5T (tesla) iMRI on the extent of resection of enhancing (high-grade) and non-enhancing (low-grade) gliomas in 104 surgical cases. This study and past studies have indicated a link between increased or more complete removal of some types of tumours and longer life expectancy and quality of life.<br /><br />Use of iMRI, according to the article, was associated with improvement in the median amount of tumour removal from 94.9% before iMRI to a final of 99.6% post-surgery after iMRI. Complete resection was possible in 65% of patients when iMRI was used compared to 34% without iMRI. All resection results were considered statistically significant.</span><br /><br /><span style="font-size: 10pt;">The results reinforce previously published evidence that IMRIS systems with high-field iMRI-guided surgery are more effective in achieving complete resection than conventional surgery using neuronavigation and direct visualisation alone, it says in a press release.</span><br /><br /><span style="font-size: 10pt;">This published evidence from neurosurgical hospitals using iMRI show that in over 40% of all cases, the surgeon chose to modify their approach based on new information from intraoperative MR imaging that would otherwise not have been available until after completing the procedure. In over 55% of glioma tumour cases, additional brain tumour was identified and resected after imaging. In addition, these centres report significant improvements&mdash;about 30 percentage points&mdash;in the portion of cases achieving total or complete tumour resection with intraoperative MR compared to cases without it.&nbsp;</span></p></div> Carotid stenosis without warning may signal memory and thinking decline 2014-04-22T10:37:00Z 2014-04-22T10:37:00Z <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><strong><span style="font-size: 11pt;">For the first time, researchers have demonstrated that asymptomatic carotid stenosis may be linked to problems in learning, memory, thinking and decision-making, compared to people with similar risk factors but no carotid stenosis.</span></strong></p> </div><div id="Text19" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study results were presented at the American Academy of Neurology&rsquo;s 66th Annual Meeting in Philadelphia, 26 April&ndash;3 May 2014.</span><br /><br /><span style="font-size: 10pt;">&ldquo;To date, the focus of diagnosis and management of carotid artery blockages has been prevention of stroke since that was the only harm that these blockages were thought to cause to patients,&rdquo; says Brajesh K Lal, Baltimore VA Medical Center and the University of Maryland School of Medicine, Baltimore, USA. &ldquo;These results underscore the importance of assessing the status of memory and thinking in people with carotid artery narrowing.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The study involved 67 patients with asymptomatic carotid stenosis with a 50% reduction in the diameter of the artery and 60 people with vascular risk factors but without the condition. Risk factors included diabetes, high blood pressure, high blood cholesterol and coronary artery disease. The participants underwent extensive testing for overall thinking abilities, and for specific aspects of thinking, such as processing speed, learning, memory, decision-making and language.</span><br /><br /><span style="font-size: 10pt;">The study found that the asymptomatic group performed significantly worse on the overall memory and thinking tests. On testing of specific aspects of thinking, they performed worse on tests for motor and processing speed, and learning and memory. Language scores did not differ between the two groups.</span><br /><br /><span style="font-size: 10pt;">&ldquo;If these findings are confirmed in larger studies, they hold significant implications for new treatment targets and open the door for more questions such as: should these patients be treated more aggressively with medications, cognitive rehabilitation, or even surgery to open up the artery,&rdquo; says Lal. &ldquo;I anticipate a large number of follow-up studies searching for causes and the best treatment option for this newly identified morbidity associated with carotid narrowing.&rdquo;</span><br /><br /><span style="font-size: 10pt;">The study was supported by the US Department of Veterans Affairs.</span></p></div> Covidien implements voluntary recall of its Pipeline embolisation device and Alligator retrieval device 2014-04-15T12:15:00Z 2014-04-15T12:15:00Z <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>Covidien has announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline embolisation device and Alligator retrieval device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.</strong></span></p> </div><div id="Text110" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">PTFE coating is used to reduce friction between devices and ease navigation through the vasculature. Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke and/or death.</span></p> <p><br /><span style="font-size: 10pt;">Covidien learned of this issue through internal product testing. The company has not received any reports of patient injuries to date related to this issue.</span></p> <p><br /><span style="font-size: 10pt;">The Pipeline embolisation device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide‐necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The Alligator retrieval device is intended for use in the peripheral and neuro‐vasculature for foreign body retrieval.</span></p> <p><br /><span style="font-size: 10pt;">A total of 32 Pipeline embolisation devices and 621 Alligator retrieval devices are affected by this recall. The products were manufactured and distributed from May 2013 to March 2014. This issue involves both the Pipeline embolisation device sold in the USA, Australia, France, Germany and United Kingdom, and the Alligator retrieval device, which is sold in the USA, Australia, Canada, Europe and Latin America.</span></p> <p><br /><span style="font-size: 10pt;">Covidien alerted customers to the recall by letter on April 1, 2014, and is arranging for replacement of the recalled products. The US Food and Drug Administration (FDA) and other regulatory bodies also have been notified.</span></p></div> First patient enrolled in registry assessing Vercise deep brain stimulation system 2014-04-15T11:55:00Z 2014-04-15T11:55:00Z <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>Boston Scientific has enrolled the first patient in a <a href=";rank=1" target="_blank"><span style="color: #800000;">new registry</span></a> to evaluate clinical outcomes and the economic value of the Vercise deep brain stimulation system in patients with Parkinson&rsquo;s disease.</strong></span></p> </div><div id="Text111" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Vercise deep brain stimulation system is an implantable medical device designed to selectively stimulate targeted areas in the brain, enabling customised therapy and helping improve the quality of life for Parkinson&rsquo;s disease patients.</span></p> <p><br /><span style="font-size: 10pt;">The multicentre, prospective study is expected to enrol up to 300 patients with Parkinson&rsquo;s disease at leading hospitals internationally and will be led by co-principal investigators <span class="xn-person">Gunther Deuschl</span>, director of the Department of Neurology, University Hospital, Kiel, <span class="xn-location">Germany</span>, and <span class="xn-person">Jan Vesper</span>, Department of Functional Neurosurgery and Stereotaxy at Heinrich-Heine University Hospital in <span class="xn-location">Dusseldorf, Germany</span>.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Parkinson&rsquo;s disease is a serious and progressive neurological disorder that affects millions of people worldwide.&nbsp;We welcome the opportunity to collect and review a more complete set of data to better understand the clinical impact and the potential of the Vercise deep brain stimulation system to help manage symptoms of Parkinson&rsquo;s disease,&rdquo; says Vesper.&nbsp;&ldquo;The unique features of the Vercise system, including the ability to selectively stimulate targeted areas of the brain via multiple independent current control, as well as the longevity of the Zero Volt battery, are designed for improved patient outcomes and enhanced clinical effectiveness.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">A preliminary analysis of the <a href=";rank=1" target="_blank"><strong>VANTAGE</strong></a> study, a multicentre, prospective clinical trial for patients with Parkinson&rsquo;s disease implanted with the Vercise deep brain stimulation system, demonstrated a mean improvement in motor function of 62.4% for patients at six months post implant, as assessed by the Unified Parkinson&rsquo;s Disease Rating Scale Part III, when compared to baseline.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">The Vercise deep brain stimulation system received CE mark approval and Australia Therapeutic Goods Administration approval in 2012 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 the treatment of Parkinson&rsquo;s disease; the system also received CE mark approval for the treatment of intractable primary and secondary dystonia in 2013.&nbsp;In the USA, the Vercise deep brain stimulation system is investigational and not available for use or sale.</span></p></div> World’s first high-field MRI-guided radiation therapy system being installed at Dutch medical centre 2014-04-15T11:38:00Z 2014-04-15T11:38:00Z <div id="ImageMain12" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction12" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Elekta, Royal Philips and University Medical Center Utrecht (the Netherlands) announced that the initial components of the world&rsquo;s first high-field magnetic resonance imaging (MRI) guided radiation therapy system are being installed at University Medical Center Utrecht. According to a company release, this marks a significant milestone toward the development of a clinical system capable of capturing highly detailed MR images of tumours and surrounding normal tissues as a patient receives radiotherapy. Development of the high-field MRI-guided linear accelerator (linac) is the mission of the MR Linac Research Consortium headed by Elekta and supported by Philips.</strong></span></p> </div><div id="Text112" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The integration of an advanced Philips 1.5 Tesla MRI system with a sophisticated Elekta radiation therapy system &ndash; enabling simultaneous imaging during beam delivery &ndash; could allow doctors to adapt radiation therapy during the procedure, increasing treatment accuracy, potentially reducing side effects and enabling increases in the therapeutic dose.</span></p> <p><br /><span style="font-size: 10pt;">On April 5, the first component &ndash; the system&rsquo;s ring gantry on which linear accelerator parts are mounted &ndash; was lowered by crane through a modular roof into one of University Medical Center Utrecht&rsquo;s radiotherapy treatment rooms. In the coming months, additional components will be integrated and the system will undergo a programme of non-clinical testing, which includes the performance evaluation of MRI sequences, testing of different adaptive delivery methods, establishing quality assurance techniques and defining workflow.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Since formation of the consortium in 2012, members have been exploring the feasibility of high-field MRI-guided radiotherapy. Installation of the first generation system is truly a major step toward moving this technology into the clinic to benefit patients,&rdquo; says Bas Raaymakers, associate professor, Department of Radiotherapy, University Medical Center Utrecht. &ldquo;We are immensely proud of the critical role that University Medical Centre Utrecht has played in collaboration with Philips and Elekta in this project for over 10 years.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Highly targeted treatments will be essential in the battle to control cancer, so together with our partners we are stepping up our efforts to create new solutions in interventional oncology,&rdquo; says Gene Saragnese, chief executive officer, Imaging Systems at Philips Healthcare. &ldquo;The installation of the first generation MR-guided radiation system at University Medical Center Utrecht is an important milestone in the development of an innovation that is designed to make a real difference in cancer care.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In addition to University Medical Center Utrecht, the other consortium members are: The University of Texas MD Anderson Cancer Center (Houston, Texas, USA), The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (Amsterdam, the Netherlands), Sunnybrook Health Sciences Centre (Toronto, Ontario, Canada) and The Froedtert &amp; Medical College of Wisconsin Cancer Center (Milwaukee, Wisconsin, USA).</span></p></div> Scottish Medicines Consortium approves Tecfidera for multiple sclerosis 2014-04-15T11:09:00Z 2014-04-15T11:09:00Z <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>The Scottish Medicines Consortium (SMC) has approved Tecfidera (dimethyl fumarate) as a first-line oral treatment for people with relapsing-remitting multiple sclerosis, the most common form of multiple sclerosis.</strong></span></p> </div><div id="Text113" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">James Overell, consultant neurologist, Institute of Neurological Sciences, Southern General Hospital, Glasgow, says, &ldquo;Scotland has&nbsp;the highest prevalence of multiple sclerosis in the world, with&nbsp;more than 10,000 people living with multiple sclerosis in the country.&nbsp;The availability of Tecfidera expands the range of options for&nbsp;people with relapsing-remitting multiple sclerosis, and will be an attractive option both for newly diagnosed patients and for those patients previously treated with a self-injectable.&nbsp;It is great that Scotland is leading the way in multiple sclerosis care by approving this new treatment.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Tecfidera has been clinically shown to significantly reduce important measures of disease activity, including relapses and the development of brain lesions, as well as to slow disability progression, while demonstrating a favourable safety and tolerability profile.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The National Institute for Health and Care Excellence (NICE) is expected to issue final guidance on Tecfidera for England and Wales summer 2014.</span></p> <p><br /><span style="font-size: 10pt;">There is currently limited access to multiple sclerosis treatments in the UK, with a recent report on inequality of access to multiple sclerosis treatments showing that the UK ranks second to last of 15 European countries studied when it comes to access to treatments. Only 21% of all multiple sclerosis patients have access to a treatment, more than three times less than Germany, where the figure stands at 69%.</span></p></div> IMRIS iMRI and ClearPoint neuro intervention system utilised for first paediatric laser ablation neurosurgery at Cook Children&apos;s Medical Center 2014-04-14T17:06:00Z 2014-04-14T17:06:00Z <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>IMRIS and MRI Interventions announced that a surgical team at Cook Children&rsquo;s in Fort Worth, Texas, USA has performed the first paediatric laser ablation procedure in an IMRIS Visius surgical theatre combining the use of MRI Interventions&rsquo; ClearPoint neuro intervention system as the navigation platform and Visius intraoperative magnetic resonance imaging (iMRI). The combination of these two medical technologies provided continuous real-time visualisation and guidance throughout a neurosurgical intervention to treat a brain tumour.</strong></span></p> </div><div id="Text114" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This initial operation went very well,&rdquo; says John Honeycutt, medical director of the Cook Children&rsquo;s Department of Neurosurgery, who led the operation. &ldquo;Access to real-time intraoperative imaging and guidance with Visius and ClearPoint technologies together allowed accurate placement of the laser catheter for thermal ablation of the tumour. Since this tumour was small, deep, and next to critical structures, having ClearPoint to assure accuracy was critical to successful ablation of the tumour with no side effects or complications. The Visius iMRI allows us to do the complete procedure in a proper operating room.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The ClearPoint navigation platform is the only technology that enables minimally-invasive neurosurgery under continuous MR guidance, offering surgeons real-time direction and a direct view of the inside of a patient&rsquo;s brain during a procedure. </span><br /> <br /><span style="font-size: 10pt;">The Visius surgical theatre allows use of MR in the operating room and over the operating room table.</span></p> <p><br /><span style="font-size: 10pt;">Using the ClearPoint system with Visius iMRI, Honeycutt was able to see and select the tumour in the brain, establish a safe trajectory, and visualise the laser probe on MR images as it was inserted to the target location. He was then able to utilise real-time MR thermometry to monitor progress as the laser probe heated the target area to the desired temperature for therapeutic destruction of the tumour tissue, preserving surrounding healthy tissue in the process. Finally, Honeycutt was able to confirm results of the procedure using the iMRI before the patient was moved from the operating table.</span></p> <p><br /><span style="font-size: 10pt;">In addition to focal laser ablation, the ClearPoint system has been used within the Visius Surgical Theatre at Cook Children&rsquo;s to facilitate &ldquo;asleep&rdquo; deep brain stimulator electrode placement for relief of symptoms related to paediatric dystonia.</span></p> <p><br /><span style="font-size: 10pt;">IMRIS and MRI Interventions technologies also have been utilised jointly at other US neuroscience centres to facilitate asleep deep brain stimulation for Parkinson&rsquo;s disease, focal laser ablation to treat brain cancer and delivery of investigational therapeutic agents directly into brain tumours.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div> NeuroVascular Quality Initiative launches first procedure module: Acute Ischaemic Stroke 2014-04-14T16:38:00Z 2014-04-14T16:38:00Z <div id="Introduction15" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Society of NeuroInterventional Surgery and M2S announced the launch of the NeuroVascular Quality Initiative, a multi-module registry system designed to track performance and outcomes data across a variety of neurovascular conditions.&nbsp;The launch debuts the Acute Ischaemic Stroke module, which will be used to track and benchmark clinical performance at the centre level and nationally, providing valuable insight into the effectiveness of endovascular interventions and associated devices in treating a condition known to be the nation&rsquo;s fourth leading cause of death.&nbsp;The NeuroVascular Quality Initiative is now officially enrolling hospitals and specialists in the Acute Ischaemic Stroke module.</strong></span></p> </div><div id="Text115" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">As neurointerventional procedures have changed the treatment landscape over the past two decades and offered thousands of patients quality treatment alternatives to traditional medical approaches, the NeuroVascular Quality Initiative is designed to track the success of these procedures, as well as demonstrate areas for improvement. Specifically, the NeuroVascular Quality Initiative will collect detailed data on:</span><br /><br /></p> <ul> <li><span style="font-size: 10pt;">Patient demographics including age, weight/height, and co-morbidities</span></li> <li><span style="font-size: 10pt;">Patient history including pre-operative medications, pre-stroke status and key time metrics associated to patient arrival and imaging</span></li> <li><span style="font-size: 10pt;">Procedure details including treatments and devices used and medications given</span></li> <li><span style="font-size: 10pt;">Follow-up including 14 day, 30 day, month and one year follow up</span></li> </ul> <p><br /><span style="font-size: 10pt;">The NeuroVascular Quality Initiative will be governed by the Society of NeuroInterventional Surgery Patient Safety Organisation, which oversees the data sharing arrangements and patient safety initiatives conducted within the NeuroVascular Quality Initiative.&nbsp;The importance of the Patient Safety Organisation structure is that it protects all comparative analyses generated within the Patient Safety Organisation from legal discovery in state and federal court. Furthermore, it permits the collection of patient identified data for quality improvement purposes without requiring consent from individual patients or prior approval from an Institutional Review Board. &nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;By encouraging the collection, aggregation, benchmarking, and analysis of clinical data, the NeuroVascular Quality Initiative will assist Society of NeuroInterventional Surgery members in understanding and improving patient outcomes in a safe environment.&nbsp;The NeuroVascular Quality Initiative will also permit tracking of new devices and device efficacy in a real world setting which is a critical need within this evolving field,&rdquo; says&nbsp;Peter Rasmussen, medical director of the Society of NeuroInterventional Surgery Patient Safety Organisation.</span></p> <p><br /><span style="font-size: 10pt;">Looking forward, the Society of NeuroInterventional Surgery Patient Safety Organisation is already planning its next-stage launch of two modules dedicated to cerebral aneurysms and cerebral arteriovenous malformations, scheduled for later this year. Additional considerations for modules include diagnostic angiography and spinal disease.</span></p></div> Cognition Therapeutics receives a US patent for Alzheimer&apos;s drug 2014-04-14T16:02:00Z 2014-04-14T16:02:00Z <div id="Introduction16" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Cognition Therapeutics has received a US patent for a drug to fight Alzheimer&rsquo;s disease. The patent describes the discovery of several candidate drug molecules which can stop the effects of the brain protein that appears to play a major role in development of Alzheimer&rsquo;s disease.&nbsp;</strong></span></p> </div><div id="Text116" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Cognition Therapeutics has pioneered the use of disease-relevant screening technology that closely models the pathology of neurodegenerative diseases and novel, high-quality central nervous system-biased chemical libraries. These platforms can predict behavioural efficacy of candidate drugs in Alzheimer&rsquo;s models. The US National Stage Application: No. 13/263,162, titled &ldquo;Inhibitors of Cognitive Decline&rdquo; was filed on&nbsp;October 6, 2011.</span></p> <p><br /><span style="font-size: 10pt;">Cognitive Therapeutics chief executive officer&nbsp;Hank Safferstein&nbsp;says, &ldquo;The allowance of this patent demonstrates the strength of Cognition Therapeutics&rsquo;s intellectual property and high-level recognition that its technologies are both relevant and of great value to the therapy and ultimate conquering of Alzheimer&rsquo;s disease.&rdquo;</span></p></div> Monarch eTNS system receives market approval from Australian Therapeutic Goods Administration 2014-04-14T15:26:00Z 2014-04-14T15:26:00Z <div id="Introduction17" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroSigma announced that it has received approval from the Therapeutic Goods Administration (TGA) to market its&nbsp;Monarch eTNS (external trigeminal nerve stimulation) system in Australia. The approval allows NeuroSigma to market the&nbsp;Monarch&nbsp;eTNS system for the adjunctive treatment of drug-resistant epilepsy in patients nine years of age and older.</strong></span></p> </div><div id="Text117" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The Monarch<em>&nbsp;</em>external trigeminal nerve stimulation system is a non-invasive adjunctive therapy for drug-resistant epilepsy that delivers low-intensity electrical current through a single-use adhesive patch to stimulate branches of the trigeminal nerve near the surface of the forehead. Patients may conveniently self-administer the therapy at home and typically use the device while sleeping. The&nbsp;Monarch<em>&nbsp;</em>eTNS system will be sold by prescription to patients in&nbsp;Australia&nbsp;under a physician&rsquo;s supervision.</span></p> <p><br /><span style="font-size: 10pt;">TGA approval was supported by data generated in Phase I and Phase II clinical trials in&nbsp;the United States measuring safety and efficacy.&nbsp;Results from a Phase II randomised controlled trial&nbsp;of eTNS for epilepsy were published in the&nbsp;February 26, 2013&nbsp;issue of&nbsp;<a href="" target="_blank"><em>Neurology</em></a>, the medical journal of the American Academy of Neurology.&nbsp;&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Mark Cook, chair of Medicine, St Vincent&rsquo;s Hospital in&nbsp;Melbourne, Australia&nbsp;noted, &ldquo;I am pleased that eTNS is now available to be prescribed for the treatment of drug-resistant epilepsy in Australia. I have been following with interest the experiences that my colleagues in&nbsp;Europe&nbsp;and&nbsp;Canada&nbsp;have had with their patients and look forward to prescribing eTNS to my patients.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">In&nbsp;the United States, eTNS is an investigational device and is limited by Federal law to investigational use.&nbsp;The US Food and Drug Administration (FDA) has given NeuroSigma approval to proceed with a pivotal Phase&nbsp;III clinical trial of eTNS in drug-resistant epilepsy. Completion of that Phase&nbsp;III study is necessary before the FDA will consider permitting the marketing and sale of eTNS in&nbsp;the United States.</span></p></div> CE mark approval for Airo mobile intraoperative CT 2014-04-14T15:04:00Z 2014-04-14T15:04:00Z <div id="ImageMain18" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction18" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Brainlab and Mobius Imaging announced CE mark approval for Airo mobile intraoperative computed tomography. The CE mark allows Brainlab to begin installation of the systems sold in the European Union.</strong></span></p> </div><div id="Text118" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;In light of the enormous market response Airo has already experienced around the world, we are eager to begin installation and use in Europe,&rdquo; says Stefan Vilsmeier, president and chief executive officer at Brainlab. &ldquo;We are dedicated to meeting the growing demand for real-time imaging in the operating room to improve and expedite clinical decision-making which benefits both the patient and the surgical team. Airo surpasses this demand and we are pleased to now be able to provide our European customers with this advanced imaging system.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to Brainlab, Airo is a unique system that advances health care delivery by producing high-quality computed tomography images that enhance surgical decision-making and support minimally invasive surgery. The portable scanner provides reproducible high-resolution images, thanks to its integrated operating room table column by TRUMPF and 32-slice helical scan detector array. Airo boasts the largest gantry opening on the market, lending itself particularly to cranial, spine and trauma procedures. Airo also connects seamlessly and automatically with Curve Information Guided Surgery by Brainlab, allowing for immediate surgical navigation on newly acquired images in the operating room.</span></p> <p><br /><span style="font-size: 10pt;">The first European shipments of Airo are expected in April 2014.</span></p></div> FDA approval for world’s first upgradeable spinal cord stimulation system 2014-04-14T11:10:00Z 2014-04-14T11:10:00Z <div id="ImageMain19" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction19" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>St Jude Medical announced the approval of its Prot&eacute;g&eacute; IPG from the US Food and Drug Administration (FDA). Prot&eacute;g&eacute; is the first and only neurostimulation system that allows spinal cord stimulation technology upgrades as they are approved to be made via software updates. Chronic pain sufferers implanted with this new device can access innovative therapies, stimulation modes, diagnostics or other features once approved through future software upgrades &mdash; without the need to surgically replace their medical device.</strong></span></p> </div><div id="Text119" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;In the first 40 years of spinal cord stimulation we&rsquo;ve seen advances in hardware but limited progress in software and programming. This new device evolves with promising therapies,&rdquo; says Timothy Deer, an interventional pain physician, president and chief executive officer of the Center for Pain Relief in Charleston, USA, and president-elect of the International Neuromodulation Society, who was the first physician to implant a Prot&eacute;g&eacute; system. &ldquo;With its upgradeability, spinal cord stimulation patients can readily access newly approved stimulation methods, allowing the latest technology to be synced with their medical device. This will reduce additional surgeries and lower the cost of care.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Until now, one of the greatest challenges with neurostimulation has been giving patients access to the latest technologies without surgically replacing their medical device. According to St Jude Medical, Prot&eacute;g&eacute; changes the standard for spinal cord stimulation, allowing patients to access future innovations and therapies once approved without the cost and risks associated with surgical replacement.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Prot&eacute;g&eacute; is the world&rsquo;s smallest neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery. It has an unmatched seven-year warranty and offers industry-leading 10-year projected battery life. It also has open-ended device longevity without an automatic shutoff. Prot&eacute;g&eacute; is built on a solid platform of success: 88% of patients report satisfaction at two years post-implant with a St Jude Medical neurostimulator, saying their quality of life has been greatly improved.</span></p></div> Anspach high speed drill system debuts at AANS 2014-04-14T10:25:00Z 2014-04-14T10:25:00Z <div id="ImageMain20" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction20" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>DePuy Synthes Power Tools announced the global launch of the Anspach EG1 high speed electric system, a next generation high-speed electric drill with multiple attachments and accessories, designed for use in neurosurgery, otology and spinal procedures. The announcement was made at the 2014 American Association of Neurological Surgeons Annual Scientific Meeting (AANS).</strong></span></p> </div><div id="Text120" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a company release, the new Anspach EG1 high speed electric system includes a high-speed drill with 30% more power than the Anspach XMAX and EMAX 2 Plus systems. The device is used to cut and shape bone, including the spine and cranium, and has a wide range of quick-coupling attachments, dissection tools and accessories for greater flexibility across procedures.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We developed the Anspach EG1 system to provide power, precision, operational efficiency and ease of use across a variety of applications that require cutting and shaping bone,&rdquo; says Ed Mackey, worldwide president, DePuy Synthes Power Tools. &ldquo;Our goal is to provide surgeons with tools that perform with precision so that they can achieve the best possible patient outcomes.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The Anspach EG1 System features integrated air-cooling, an operating speed of up to 80,000 rpm, minimal start-up kick, and is compatible with automated washing and sterilisation.</span></p></div> Antioxidant shows promise in supporting treatment for ALS 2014-03-25T15:35:00Z 2014-03-25T15:35:00Z <div id="Introduction21" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Researchers at The Center of Free Radical and Biomedical Research at Facultad de Medicina, Universidad de la Republicain Uruguay announced the discovery that the antioxidant MitoQ prolonged the lifespan and health-span of mice suffering from amyotrophic lateral sclerosis-like (ALS) disease, and successfully improved functional parameters related to muscular strength and reversed mitochondrial damage in nervous and muscle tissue. The study was published in the journal <a href="" target="_blank"><span style="color: #800000;"><em>Free Radical Biology and Medicine</em></span></a> and the findings of this study point to a positive direction for those suffering from ALS.</strong></span></p> </div><div id="Text121" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">MitoQ is a mitochondria-targeted antioxidant created over a decade ago that reduces mitochondrial oxidative stress and, when administered to a mouse model of ALS, delayed the progression of the fatal neurodegenerative disease. Mitochondria are also known as cellular batteries and provide energy to cells.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The results of this study show a promise that mitochondria-targeted antioxidants could potentially be of use for the treatment of ALS, a condition for which there is currently no cure.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;This study supports the role of mitochondrial dysfunction in the development and progression of ALS, which may allow for the development of more mitochondria-targeted therapies to fight this disease,&rdquo; says Rafael Radi, director of the Center and a key member of the study&rsquo;s research team. &ldquo;We also found that MitoQ has beneficial effects in the murine model of ALS, which will likely lead to clinical trials using MitoQ with ALS patients and hopefully lead to extend the survival and improve the quality of life of ALS patients.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Researchers sought to decrease oxidative stress in mitochondria as a way to slow the death of motor neurons and disease progression within the ALS-induced mice. MitoQ works by accumulating inside the mitochondria and performing antioxidant activity, while allowing the molecule to act specifically at the site of free radical formation in the cells and efficiently reduce oxidative stress.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />To conduct their study, scientists administered MitoQ to the mice&rsquo;s drinking water from a time when early symptoms of neurodegeneration had become evident. After 20 days of administration, MitoQ was detected in all tested tissues and the treatment had slowed the decline of mitochondrial function in both the spinal cord and the quadriceps muscles.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;MitoQ increased approximately 6% the survival of the treated mice,&rdquo; notes Patricia Cassina, another key senior member of the research team. &ldquo;This might seem small, but it&rsquo;s in the range of the best that other drugs have been able to achieve with this model in which the disease progression is extremely fast and there is a small window of opportunity to improve symptoms and survival.&rdquo; Radi notes that MitoQ administration also resulted in improved muscular strength as evaluated by functional tests performed in the animals.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />An advantage of MitoQ is that it has been tested for safety in a variety of clinical human trials since its inception in the late 1990s. The Center of Free Radical and Biomedical Research is now evaluating the possibility of conducting clinical human trials specifically related to MitoQ and its effects on ALS patients.</span></p></div> Metactive debuts embolization technology with presentation at SIR 2014-03-24T11:14:00Z 2014-03-24T11:14:00Z <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>Metactive Medical presented new nonclinical data on one of its investigational devices at the&nbsp;Society of Interventional Radiology&rsquo;s (SIR) Annual Scientific Meeting. The presentation focused on the company&rsquo;s device that addresses the cerebral aneurysm market.</strong></span></p> </div><div id="Text122" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The company&rsquo;s chief executive officer, F Nicholas Franano, made an oral presentation titled &ldquo;Over-the-wire Device for Immediate, Complete and Durable Occlusion of Saccular Cerebral Aneurysms&rdquo; during the &ldquo;Arterial Aneurysms and Dissection&rdquo; session at the meeting.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Endovascular embolization of cerebral aneurysms with coils was a major advance when it was introduced more than 20 years ago,&rdquo; says Franano. &ldquo;The technology that we are developing at Metactive builds upon that innovation by providing a next-generation device that has the potential to provide better patient outcomes, to be faster and easier for physicians to use, and to improve hospital profitability.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">At SIR, Metactive presented findings from a recent pilot nonclinical study in which the company&rsquo;s cerebral aneurysm embolic device demonstrated immediate and complete mechanical occlusion of a large, terminal saccular aneurysm, as well as full endothelialisation and sealing of the aneurysm neck at one month. By comparison, in the same aneurysm model, treatment using widely used conventional coils did not provide immediate and complete occlusion. Compared to coiling, the procedure to place Metactive&rsquo;s device took half as long, and the devices cost one-third as much. While Metactive has only completed a handful of nonclinical procedures to date, these excellent early results support further investigation.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;If Metactive can demonstrate that this new device can provide better clinical outcomes with much lower procedure time and complexity, and large reductions in cost, then I believe it has the potential to provide real value for patients, physicians, hospitals and payers -- especially for large aneurysms,&rdquo; says Kieran Murphy, interventional neuroradiologist and professor of radiology at the University Health Network Toronto in Ontario, Canada, and director of clinical faculty at the Techna Research Institute.</span></p></div> ADAPT a safe and simple technique for ischaemic stroke thrombectomy 2014-03-21T11:12:00Z 2014-03-21T11:12:00Z <div id="ImageMain23" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction23" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A direct aspiration first pass technique (ADAPT) with a large bore aspiration catheter has been shown to be &ldquo;fast, safe, simple and effective method&rdquo; for acute ischaemic stroke thrombectomy. The results were published in the <em><a href="" target="_blank">Journal of of NeuroInterventional Surgery</a>.</em></strong></span></p> </div><div id="Text123" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The authors of the ADAPT FAST study (Aquilla S Turk, Medical University of South Carolina, USA and colleagues) note that aspiration thrombectomy using the Penumbra system (Penumbra) and stent retrievers is effective for vessel revascularisation but has &ldquo;yielded only modest clinical results.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Therefore, Turk and colleagues used the novel ADPAT technique as their first approach for thrombectomy and report the follow-up of their initial experience. Patients who were included in the study (98 with 100 occlusions) had large vessel, cerebral vessel occlusion with a viable penumbra and a less than one-third ischaemic vascular territory.</span></p> <p><br /><span style="font-size: 10pt;">Turk <em>et al</em> state that during the study period, the 5MAX ACE became available therefore they also compared the performance of the 5MAX ACE and the 5MAX (Penumbra).</span></p> <p><br /><span style="font-size: 10pt;">The degree of vessel occlusion was measured before and after the procedure and defined in the modified Thrombolysis and Cerebral Infarction (TICI) classification. Successful recanalisation was defined as TICI score &ge;2b post-treatment. Procedure time was classed as from the time of groin access to at least TICI 2b revascularisation.</span></p> <p><br /><span style="font-size: 10pt;">The overall successful recanalisation rate (TICI 2b&ndash;3) was 95%. The average time to recanalisation was 36.6 minutes (SD=26.4 minutes). The aspiration component of the ADAPT technique successfully recanalised occluded vessels 78% of the time and when it was used as a standalone technique the average time to recanalisation was 31.6 minutes (SD=23.3 minutes). The authors add that, in cases where an adjunctive device, such as a stent retriever was used, the time to revascularisation was longer (p&lt;0.0001; average time 56.8 minutes; SD=29.1 minutes).</span></p> <p><br /><span style="font-size: 10pt;">Overall the 5MAX catheter was used in 44 cases, the 5MAX ACE was used in 44 cases, the 3MAX (Penumbra) in six cases, in four cases the Navien 058 (EV3, Covidien) and in one case the Neuron 088 MAX (Penumbra). TICI 2b or 3 revascularisation with aspiration alone was achieved in 75% of cases where the 5MAX was used vs. 82% (p=0.44) when a 5MAX ACE was used.</span></p> <p><br /><span style="font-size: 10pt;">The National Institutes of Health Stroke Scale (NIHSS) at presentation was 17.3 (median 17; SD=6.4) and was improved to 7.3 (median 4; SD=7.5).</span></p> <p><br /><span style="font-size: 10pt;">The authors report that there were no incidences of postprocedure spontaneous intracranial haemorrhage. They add that, compared with the outcomes of the stent retriever data reported, ADAPT has similar rates of good functional outcome (mRS 0&ndash;2), mortality and device-related complications.</span></p> <p><br /><span style="font-size: 10pt;">Modified Rankin Scale score (mRS) was reported in 81 patients with 40% achieving a mRS score of 0&ndash;2, and in 20% of cases an score of 6 at three-month follow-up was achieved.</span></p> <p><br /><span style="font-size: 10pt;">In 78% of cases, according to Turk <em>et al</em>, where ADAPT alone was successful, 47% of patients achieved a mRS score on 0&ndash;2 and 14% has a score of 6. Where a stent retriever was used with ADAPT (or was unsuccessful), 18% achieved mRS 0&ndash;2 and 35% achieved a score of 6.</span></p> <p><br /><span style="font-size: 10pt;">Concluding, the authors say that catheter aspiration thrombectomy is an effective, novel technique to achieve revascularisation as a first-line therapy. It has previously only been reported as a bailout after failure of traditional revascularisation techniques.</span></p> <p><br /><span style="font-size: 10pt;">They say that ADAPT is made possible because of the availability of newer, flexible, atraumatic, large bore aspiration catheters and add that their &ldquo;multicentre series supports the hypothesis that, in comparison with modern thrombectomy devices, ADAPT is a fast, simple, efficient and safe strategy to achieve revascularisation in patients with acute ischaemic stroke secondary to large vessel occlusion.&rdquo;</span></p></div> Morphology and interval growth are predictive factors of intracranial aneurysm rupture 2014-03-21T11:01:00Z 2014-03-21T11:01:00Z <div id="ImageMain24" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction24" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>In a study conducted by William Mehan <em>et al,</em> it was found that for patients with unruptured intracranial aneurysms, multilobulated morphology and interval growth of the unruptured aneurysms are &ldquo;characteristics predictive of a higher risk of subsequent rupture during conservative CT angiography (CTA) follow-up.&rdquo;</strong></span></p> </div><div id="Text124" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Mehan and colleagues (Massachusetts General Hospital, Harvard Medical School, Boston, USA) say that, although there have been other multicentre prospective studies (ISUIA, UCAS and SUAVE) demonstrating characteristics associated with rupture, the &ldquo;natural history of unruptured intracranial aneurysms remain uncertain.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Therefore, the Massachusetts group aimed to identify factors predictive of rupture, or confirm the characteristics found in the aforementioned studies. They say that this is important as aneurysm rupture is associated with &ldquo;significant morbidity and mortality&rdquo;.</span></p> <p><br /><span style="font-size: 10pt;">The single centre study, published in the <a href="" target="_blank"><em>Journal of NeuroInterventional Surgery </em></a>was a retrospective review of patients with unruptured intracranial aneurysms followed with serial CT angiography studies between January 1999 and December 2010. The following features for each aneurysm were catalogued from the official radiologic reports and CTA images: maximum diameter, growth between follow-up studies, location, multiplicity, wall calcification, intraluminal thrombus and morphology. Univariate logistic regression analysis of the potential independent risk factors for aneurysm rupture was performed. Statistically significant risk factors from the univariate analysis were then entered into a multivariate logistic regression analysis. &nbsp;</span></p> <p><br /><span style="font-size: 10pt;">During the study period, a total of 3,033 cerebral aneurysms were referred to the institution, of which 614 ruptured. A total of six aneurysms in six different patients ruptured during the CT angiography follow-up period, yielding an overall rupture rate of 3.3% and an annual rupture rate of 0.97%. The investigators initially performed a univariate logistic regression analysis of potential risk factors for aneurysm rupture. All six ruptured aneurysms were at least 9mm in maximum diameter compared with a mean of 5.4mm for the unruptured aneurysms (p=0.003).</span></p> <p><span style="font-size: 10pt;">&nbsp;</span><br /><span style="font-size: 10pt;">Four of six ruptured aneurysms demonstrated interval growth by the time of rupture compared with four of 174 unruptured aneurysms (p&lt;0.0001). In one of the four ruptured aneurysms that enlarged between serial CT angiography follow-up studies, interval growth was demonstrated on CT angiography studies obtained prior to the study performed at the time of rupture. The mean growth for the aneurysms that ruptured was 4.25mm. Four of six ruptured aneurysms demonstrated multilobulated morphology compared with 16 of 174 of unruptured aneurysms. In three of the four multilobulated aneurysms that ruptured, multilobulated morphology was demonstrated on CT angiography studies obtained prior to the study performed at the time of rupture. A single ruptured aneurysm demonstrated neither interval growth nor multilobulated morphology on CT angiography. &nbsp;</span></p> <p><br /><span style="font-size: 10pt;">According to Mehan <em>et al</em>, the non-invasive nature of CT angiography coupled with its relatively high spatial resolution, speed and availability make CT angiography an excellent modality for the serial follow-up of known unruptured intracranial aneurysms. Based on the study findings, unruptured intracranial aneurysms with a multilobulated morphology and/or interval growth between follow-up CT angiography studies are at increased risk of rupture. Further studies of conservative CT angiography follow-up of unruptured intracranial aneurysms with longer follow-up periods and larger numbers of ruptured aneurysms are necessary.</span></p> <p><br /><span style="font-size: 10pt;">The authors conclude that this study demonstrates that multilobulated morphology and interval growth of unruptured intracranial aneurysms are characteristics predictive of a higher risk of subsequent rupture during conservative CT angiography follow-up. The presence of these features could help guide clinical decisions as to whether these aneurysms are followed conservatively or treated.</span></p></div> FDA approval for Neuraceq (florbetaben F18 injection) 2014-03-21T10:08:00Z 2014-03-21T10:08:00Z <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>The US Food and Drug Administration (FDA) has approved Piramal Imaging&rsquo;s Neuraceq (florbetaben F18 injection). This approval comes only four weeks after receiving marketing authorisation for Neuraceq from the European Commission.</strong></span></p> </div><div id="Text125" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer&rsquo;s disease and other causes of cognitive decline.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Centers for Medicare &amp; Medicaid Services has declared it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development programmes. The objective of these programmes is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The FDA approval of Neuraceq is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation programme. Images were analysed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq.</span></p></div> Data from a study of PBA symptoms in veterans with mild traumatic brain injury presented 2014-03-20T15:15:00Z 2014-03-20T15:15:00Z <div id="Introduction26" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Avanir Pharmaceuticals announced the presentation of results from a first-of-its-kind study of pseudobulbar affect (PBA) symptoms in veterans with mild traumatic brain injury conducted in collaboration with the Department of Veterans Affairs and Evidera. The study will be presented at the Tenth World Congress on Brain Injury in&nbsp;San Francisco, USA, on Friday 21 March 2014.</strong></span></p> </div><div id="Text126" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;It is estimated that between 12% and 23% of service members deployed to&nbsp;Iraq&nbsp;and/or&nbsp;Afghanistan&nbsp;have sustained a traumatic brain injury and this study suggests that many of these men and women may also be suffering from pseudobulbar affect, a distressing neurological condition marked by uncontrollable, disruptive episodes of crying or laughing,&rdquo; says&nbsp;Regina McGlinchey, director of the Translational Research Centre for Traumatic Brain Injury and Stress Disorders, a Veterans Affairs Rehabilitation Research &amp; Development Service, Traumatic Brain Injury Center of Excellence at Veterans Affairs Boston Healthcare System. </span><br /><br /><span style="font-size: 10pt;"> &ldquo;More than half of responders from our study reported that they are experiencing symptoms of pseudobulbar affect. Those with pseudobulbar affect symptoms reported significantly worse health-related quality of life scores, and there appeared to be a high correlation between pseudobulbar affect symptoms and post-traumatic stress disorder.&rdquo;</span><br /><br /><span style="font-size: 10pt;">Highlights from the cross sectional survey results of 4,283 patients within the Veterans Affairs system include:</span><br /><br /></p> <ul> <li><span style="font-size: 10pt;">758 (19%) veterans with traumatic brain injury responded to the survey an unusually high response rate for similar studies.&nbsp;</span></li> <li><span style="font-size: 10pt;">60% of respondents reported pseudobulbar affect symptoms, characterised by the presence of involuntary, uncontrollable episodes of crying and/or laughing that were exaggerated or even contrary to how they felt at the time.</span></li> </ul> <p><br /><span style="font-size: 10pt;">In contrast, other commonly perceived challenges faced by veterans were reported less frequently, including: post-traumatic stress disorder (48%) major depression (31%) and anxiety disorders (18%).</span></p> <p><br /><span style="font-size: 10pt;">Veterans who suffer from pseudobulbar affect symptoms were more likely to also suffer from post-traumatic stress disorder, a finding not previously understood or recognised.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Among veterans with scores &ge;13 in the Center for Neurologic Study-Lability Scale (CNS-LS), denoting pseudobulbar affect symptoms, 54% reported suffering from post-traumatic stress disorder versus approximately 32% of CNS-LS negative veterans.</span></p> <p><br /><span style="font-size: 10pt;">In terms of measuring overall health status, those that suffered from pseudobulbar affect symptoms scored lower on the EQ-5D index (an international, standardised, general measure of health status) suggesting that they have an extra burden impacting their quality of life.</span></p> <p><br /><span style="font-size: 10pt;">More than 94% of CNS-LS positive Veterans report at least some problems with pain/discomfort or anxiety/depression, the majority of whom had symptoms of at least moderate severity.</span></p> <p><br /><span style="font-size: 10pt;">Veterans who suffer from pseudobulbar affect symptoms were also significantly more likely to be on antidepressants than those without pseudobulbar affect symptoms.</span></p> <p><br /><span style="font-size: 10pt;">46% of CNS-LS positive veterans reported being on antidepressants versus approximately 31% of CNS-LS negative veterans</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Results from this benchmark study suggest a high prevalence of pseudobulbar affect symptoms among veterans with mild traumatic brain injuries, an issue that significantly compounds the burden on veterans as more troops reintegrate into society after active service,&rdquo; says&nbsp;Joao Siffert, chief medical officer at Avanir. &ldquo;Our ultimate goal with this research is to collaborate with the Veteran Affairs to develop a screening protocol for identifying pseudobulbar affect symptoms to help improve diagnosis, treatment and ultimately the quality of care for our nation&rsquo;s veterans. Additionally, understanding the interplay between pseudobulbar affect and other brain injury neuropsychiatric consequences may help guide a more specific and comprehensive approach to patient care.&rdquo;</span></p></div> Functional brain imaging can provide better diagnosis and treatment monitoring in persons with traumatic brain injury 2014-03-20T12:49:00Z 2014-03-20T12:49:00Z <div id="Introduction27" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A new paper published by a joint US and Canadian team in <a href="" target="_blank"><em>PLOS One</em></a> suggests SPECT (single photon emission computed tomography)<em>&mdash;</em>a functional brain imaging modality that produces images of blood flow to the brain, showing areas of over or under-activity<em>&mdash;</em>is useful in both identifying and guiding treatment for those with traumatic brain injuries.</strong></span></p> </div><div id="Text127" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Using standardised search criteria, the study examined the National Library of Medicine&rsquo;s largest research databases to identify1600 papers on SPECT and traumatic brain injury from the world literature over the past 30 years. Of these, 71 studies, involving 2634 patients, were considered of the highest quality and were included in the review. Nineteen studies followed traumatic brain injury patients over time and five looked at the effects of treatment interventions.&nbsp;</span><br /> <br /><span style="font-size: 10pt;">The findings of the systematic review include: 1) SPECT is more sensitive compared to standard anatomical CT and MRI in detecting brain abnormalities in traumatic brain injury; 2) SPECT correlates with psychological and neurological outcomes; 3) SPECT can be used to evaluate treatment interventions. SPECT scans showed abnormalities not seen on MRI and CT in all 10 of the studies that investigated this question (100%).&nbsp;</span><br /> <br /><span style="font-size: 10pt;">It was found that a normal SPECT study right after an injury is highly predictive of a good clinical outcome for patients, but an abnormal scan right after an injury was not highly predictive of the ultimate outcome (59%), as the brain has many healing mechanisms. But if the second scan three months later was also abnormal, the scan was highly predictive of poor outcome.&nbsp;</span><br /> <br /><span style="font-size: 10pt;">&ldquo;The bottom line is if a brain SPECT is normal after traumatic brain injury, patients do well but we need to see at least two abnormal scans over time to see if they do poorly,&rdquo; says psychiatrist and SPECT expert Daniel Amen, one of the co-authors of the paper. &ldquo;These important findings can have important implications for diagnosis and brain rehabilitation in persons with traumatic brain injury.&rdquo;&nbsp;</span><br /> <br /><span style="font-size: 10pt;">According to Theodore Henderson, a senior author on the study, &ldquo;Persons with mild traumatic brain injury, which is often referred to as concussion or post-concussion syndrome, may not be properly identified as having credible neurological problems because commonly used anatomical CT or MRI scans in mild brain trauma are abnormal less than 10% of the time. These same patients may have recurring psychiatric symptoms such as depression, attention problems, and impulse control issues. Commonly, they are referred to psychiatrists who generally do not use neuroimaging to diagnose and treat brain disorders. Indeed, many cases of treatment-resistant depression turn out to have undiagnosed traumatic brain injury. Our study shows that SPECT can be useful and a true value-add in guiding diagnosis and treatment of such patients.&rdquo;&nbsp;</span><br /> <br /><span style="font-size: 10pt;">&ldquo;Ultimately, how would physicians ever know if the TBI was significant unless they ordered a functional imaging study like SPECT?&rdquo; says Amen. &ldquo;Our paper shows that brain SPECT can provide answers that may guide diagnosis and treatment of patients with Traumatic Brain Injury.&rdquo;</span></p></div> Prodigy spinal cord stimulation system gets CE mark approval 2014-03-20T11:29:00Z 2014-03-20T11:29:00Z <div id="ImageMain28" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction28" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>St Jude Medical announced the CE mark approval and European launch of its Prodigy chronic pain system with burst technology. As the first and only implantable neuromodulation system that delivers burst stimulation, the Prodigy system is designed to reduce pain, improve patient satisfaction and allow reduced paraesthesia. The new device offers patients traditional tonic spinal cord stimulation in addition to burst technology for improved stimulation options.</strong></span></p> </div><div id="Text128" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Burst technology expands treatment options for patients suffering from chronic pain and provides significant relief so they can reclaim their quality of life,&rdquo; says Dirk De Ridder, neurological professor of Neurosurgery, from the University of Otago in Dunedin, New Zealand. &ldquo;Prodigy&rsquo;s pioneering stimulation mode allows me to tune therapy to my patient&rsquo;s unique pain condition. Burst holds promise to fill the void where alternative stimulation modes fail to control patients&rsquo; pain or for those who lose therapeutic benefit over time.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />St Jude Medical&rsquo;s new burst technology offers intermittent &ldquo;bursts&rdquo; of stimulation designed to provide an alternative therapy method for chronic conditions such as back pain. In addition, burst stimulation has been demonstrated to minimise paraesthesia in some patients which can often fluctuate with posture and body position changes. Early evidence suggests that by enabling the delivery of both modes of stimulation, clinicians can more effectively adjust therapy to address the patient&rsquo;s unique pain condition.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Prodigy system features the longest-lasting battery life, even at the highest settings, of any rechargeable spinal cord stimulation device in its class. Additionally, its small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Through an Investigational Device Exemption from the US Food and Drug Administration (FDA), the St. Jude Medical study called <a href=";rank=1" target="_blank"><strong>SUNBURST</strong></a> (Success using neuromodulation with burst) is evaluating whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation. The Prodigy neurostimulator is not approved for use in the USA.</span></p></div> Statins slow the progression of advanced multiple sclerosis 2014-03-20T11:07:00Z 2014-03-20T11:07:00Z <div id="Introduction29" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>In a two-year clinical trial involving 140 patients with secondary progressive multiple sclerosis, the drug simvastatin slowed brain shrinkage, which is thought to contribute to patients&rsquo; impairments. Supporting this finding, patients on simvastatin achieved better scores on movement tests and questionnaires that assess disability than patients taking a placebo.</strong></span></p> </div><div id="Text129" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The authors of the new study, which was led by Imperial College London, said the findings were very encouraging, but would need to be replicated in a larger trial. The work is published in <em>the Lancet</em>.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;At the moment, we don&rsquo;t have anything that can stop patients from becoming more disabled once multiple sclerosis reaches the progressive phase,&rdquo; says Richard Nicholas, co-author of the study from the Department of Medicine at Imperial. &ldquo;Discovering that statins can help slow that deterioration is quite a surprise. This is a promising finding, particularly as statins are already cheap and widely used.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We need to do a bigger study with more patients, possibly starting in the earlier phase of the disease, to fully establish how effective it is,&rdquo; he added.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Nicholas ran the trial with Jeremy Chataway, then in the Department of Medicine at Imperial and now at University College London.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Statins are taken by millions of people to lower cholesterol and prevent heart disease, but it&rsquo;s unclear why they would have a beneficial effect on multiple sclerosis. Some small studies have found a small benefit from statins in relapsing remitting multiple sclerosis, which is more treatable.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Secondary progressive multiple sclerosis has proven more challenging to alleviate. In 2013, cannabis became the latest drug to prove unsuccessful at slowing the progression of multiple sclerosis in a clinical trial.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />This clinical trial is the culmination of long-standing research led by John Greenwood at the UCL Institute of Ophthalmology showing the potential therapeutic benefits of using statins to treat autoimmune diseases such as multiple sclerosis and uveitis.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Greenwood says, &ldquo;After nearly two decades of research, it is immensely gratifying to see this work progress into the clinic to deliver benefits to patients.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study was funded by J P Moulton Foundation, Berkeley Foundation, Multiple Sclerosis Trials Collaboration, Rosetrees Trust and the National Institute for Health Research (NIHR).</span></p></div> First patient enrolled in new CGuard CARENET clinical trial 2014-03-19T14:54:00Z 2014-03-19T14:54:00Z <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 announced that it has successfully enrolled the first patient in the CARENET (Carotid embolic protection study using MicroNet) multicentre European clinical trial for the new CGuard carotid embolic protection system.</strong></span></p> </div><div id="Text130" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The CARENET clinical study is a multi-specialty trial that is designed to provide data and evidence of the CGuard carotid embolic protection system to better understand the complexities and challenges of patients that experience carotid artery disease.&nbsp; The objective of the CARENET study is to evaluate the safety and efficacy of the CGuard system in the treatment of carotid lesions in consecutive patients suitable for carotid artery stenting.</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 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 travelling distally in the arteries 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 which is liberated during the procedure.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;I have treated many patients with carotid artery disease over the years, and I am excited to participate in the CARENET clinical trial using the unique CGuard embolic protection system,&rdquo; states Joachim Schofer, from the Hamburg University Cardiovascular Center, in Hamburg, Germany. &ldquo;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 using this device with other sites throughout Europe in the CARENET trial to help treat my patients with carotid disease.&rdquo;</span></p></div> Dartmouth-Hitchcock Medical Centre inaugurates Visius surgical theatre 2014-03-19T12:12:00Z 2014-03-19T12:12:00Z <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>IMRIS announced that neurosurgeons at Dartmouth-Hitchcock Medical Centre in Lebanon, USA, have completed several cases to inaugurate use of intraoperative MRI (iMRI) within the Visius surgical theatre inside the hospital&rsquo;s Centre for Surgical Innovation. The Centre for Surgical Innovation has the only operating suite in the world with both Visius iMRI and intraoperative CT (iCT) modalities able to serve multiple operating rooms without moving the patient.</strong></span></p> </div><div id="Text131" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The initial case - a revision right craniotomy for a meningioma - was also the first time Visius iMRI was used with next generation leading 3.0 tesla technology which includes applications to deliver better image quality with higher signal-to-noise ratio, faster 3-dimensional image acquisition, and improved ease-of-use and workflow.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;These first few cases have gone very well in terms of producing images during the cases and confirming that we have accomplished what we had&nbsp; intended,&rdquo; says David Roberts, Dartmouth-Hitchcock neurosurgery section chief and professor of surgery and neurology at the Geisel School of Medicine, who led the first case. &ldquo;We expect the iMRI inside the Centre for Surgical Innovation will expand our vision beyond what we can see with the naked eye to reach diseased tissue that is sometimes located within challenging to navigate anatomy,&rdquo; he adds. &ldquo;The operating room suite will have a direct value to patients by allowing us to do surgery better than before.&rdquo;</span></p></div> FDA allows marketing of first medical device to prevent migraine 2014-03-19T10:17:00Z 2014-03-19T10:17:00Z <div id="ImageMain32" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction32" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The US Food and Drug Administration (FDA) has approved marketing of Cefaly, the first device as a preventative treatment for migraine. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorised for use prior to the onset of pain.</strong></span></p> </div><div id="Text132" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Cefaly provides an alternative to medication for migraine prevention,&rdquo; says Christy Foreman, director of the Office of Device Evaluation at the FDA&rsquo;s Centre for Devices and Radiological Health. &ldquo;This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.&rdquo;&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Cefaly is a small, portable, battery-powered, prescription device that resembles a plastic headband worn across the forehead and atop the ears. The user positions the device in the centre of the forehead, just above the eyes, using a self-adhesive electrode. The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches. The user may feel a tingling or massaging sensation where the electrode is applied. Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes.</span></p> <p><br /><span style="font-size: 10pt;">The FDA reviewed the data for Cefaly through the <em>de novo</em> premarket review pathway, a regulatory pathway for generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.</span></p> <p><br /><span style="font-size: 10pt;">The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium.&nbsp;&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">The patient satisfaction study showed that more than 53% of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session.</span></p> <p><br /><span style="font-size: 10pt;">No serious adverse events occurred during either study.&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Cefaly is manufactured by STX-Med in Herstal, Liege, Belgium.</span></p></div> Final results of Neuralstem phase I stem cell trial in ALS published 2014-03-18T13:00:00Z 2014-03-18T13:00:00Z <div id="Introduction33" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Neuralstem Inc announced that the final results from the phase I safety trial using NSI-566 spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS) were published in the peer-reviewed journal, <span style="color: #993300;"><a href="" target="_blank"><span style="color: #993300;"><em>Annals of Neurology</em></span></a></span>.</strong></span></p> </div><div id="Text133" style="clear:both; text-align:left"><p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 10pt;">In Intraspinal Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis: Phase I Trial Outcomes, results were updated from phase I interim data, reported earlier, to include data from the last six patients in the trial. These six patients were the first to receive cervical stem cell transplants. Three of them were also the first to be transplanted along the length of their spines, in both the lumbar and the cervical regions. The results showed that NSI-566 human spinal cord stem cells can be safely transplanted in both the lumbar and cervical spinal cord segments, did not accelerate disease progression, and warrant further study on dosing and therapeutic efficacy. Furthermore, the researchers were able to identify potential therapeutic windows, suggesting that more injections, as well as multiple injections, are better and may increase both the length and the magnitude of the potential benefits. This is consistent with the hypothesised neuroprotective mechanism-of-action for this cell therapy.</span><br /><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Since concluding phase I, the trial has progressed to phase II at three centres in USA,<span class="apple-converted-space">&nbsp;</span><span class="xn-org"><span style="box-sizing: border-box;">Emory University</span></span><span class="apple-converted-space">&nbsp;</span>Hospital in<span style="box-sizing: border-box;"> <span class="xn-location">Atlanta, Georgia</span></span>, the ALS Clinic at the<span class="apple-converted-space">&nbsp;</span><span class="xn-org"><span style="box-sizing: border-box;">University of Michigan</span></span><span class="apple-converted-space">&nbsp;</span>Health System, in<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Ann Arbor, Michigan</span></span>, and Massachusetts General Hospital in<span class="apple-converted-space">&nbsp;</span><span class="xn-location"><span style="box-sizing: border-box;">Boston, Massachusetts</span></span>, which treated its first patient in February. Treatment of three of the five phase II cohorts has been completed.</span><br /><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">&ldquo;Although this was a phase I trial, and functional outcome data were collected for the purpose of assessing safety, we performed secondary analyses of these data as a means to gain insight into how cellular transplantation affected disease progression rates and to inform outcome assessment approaches in future trial phases,&rdquo; says<span class="apple-converted-space">&nbsp;</span><span class="xn-person"><span style="box-sizing: border-box;">Eva Feldman</span></span>, director of the A Alfred Taubman Medical Research Institute, director of research of the ALS Clinic at the<span class="apple-converted-space">&nbsp;</span><span class="xn-org"><span style="box-sizing: border-box;">University of Michigan</span></span><span class="apple-converted-space">&nbsp;</span>Health System, principal investigator for the NSI-566/ALS trial and lead author. Feldman is also an unpaid consultant to Neuralstem.</span><br /><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">&ldquo;Pre-surgical disease progression rates for the various functional outcome measures were calculated to create slopes for each patient, so that we could determine if post-surgical data points, at six, nine, 12 and 15 months, improved relative to predicted points. We also did analyses to determine which, if any, functional outcome assessment most closely correlated with the overall ALSFRS-R scores,&rdquo; says Feldman. &ldquo;Comparison of the outcome data to predicted outcome points in group E (patients who received both lumbar and cervical injections) revealed improvements in a significant number of measures at six, nine, 12 and 15 months post-surgery. Overall, 50% of the patients in the trial showed improvement across multiple clinical measures at the same time points. We also found that a measure of grip strength correlated most closely with the overall ALSFRS-R scores.&rdquo;</span><br /><br /><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Feldman adds, &ldquo;Finally, we conducted an analysis to identify the most biologically active period of the injected cells for the patients receiving both lumbar and cervical injections. This analysis reveals that the maximal periods of benefit correlate with the two surgical interventions. Importantly, as the &lsquo;bell-shaped curve&rsquo; associated with each intervention is likely due to disease progression, increasing the total cell dose, and applying multiple applications of these stem cells, may increase both the length and magnitude of the potential benefit. We are of course exploring this very dosing regimen in our ongoing phase II trial.&rdquo;</span></p></div> Study finds no link between football play and neurocognitive function in adolescent athletes 2014-03-17T12:03:00Z 2014-03-17T12:03:00Z <div id="ImageMain34" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction34" style="clear:both;"> <p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-size: 11pt;"><strong><span class="xn-location"><span style="font-family: Helvetica, sans-serif; color: #333333;">A </span></span><span style="font-family: Helvetica, sans-serif; color: #333333;">new study presented at the 2014 Annual Meeting of the<span class="apple-converted-space">&nbsp;</span></span><span style="font-family: Helvetica, sans-serif;">American Academy of Orthopaedic Surgeons<span class="apple-converted-space"><span style="color: #333333;">&nbsp;</span></span><span style="color: #333333;">(AAOS) found no link between neurocognitive function and years of football play in adolescent athletes.</span></span></strong></span></p> </div><div id="Text134" 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;"><span style="font-family: Helvetica, sans-serif; color: #333333;">According to the US Center for Disease Control (CDC), between 1.6 and 3.8 million sports and recreation-related<span class="apple-converted-space">&nbsp;</span></span><span style="font-family: Helvetica, sans-serif;">concussions<span class="apple-converted-space"><span style="color: #333333;">&nbsp;</span></span><span style="color: #333333;">occur each year in the US, most of which go untreated by medical professionals. Concussions and sub-concussive hits (repeated head blows without immediate, visible signs or symptoms of neurological damage) are especially common in high school football. Several recent research studies have found a link between sub-concussive head blows in football and neurocognitive decline in adolescents.</span></span></span></p> <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;">In a new study, researchers retrospectively reviewed data obtained between<span class="apple-converted-space">&nbsp;</span><span class="xn-chron">August 1998</span><span class="apple-converted-space">&nbsp;</span>and<span class="apple-converted-space">&nbsp;</span><span class="xn-chron">August 2001</span><span class="apple-converted-space">&nbsp;</span>on 1,289<span class="apple-converted-space">&nbsp;</span><span class="xn-location">New Orleans</span><span class="apple-converted-space">&nbsp;</span>high school football players, including years of participation, age and concussion history, as well as scores on common neuropsychological tests: digit symbol substitutions (DSS), pure reaction time (PRT) and choice reaction time (CRT). The mean player age was 15.9, and the mean play time, 4.4 years. Only 4% of the athletes in the study suffered a sport concussion.</span></p> <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;">Age was positively related to performance on the digit symbol substitutions task, but years of football remained significantly and positively associated with digit symbol substitutions after controlling for age. There was no association between history of concussion and digit symbol substitutions, despite adding concussion to the model with years of football participation, and no significant association between years of football participation and pure reaction time.</span></p> <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;">&ldquo;The correlation between the number of years of football participation and the performance on the digit symbol substitution test does not support the hypothesis that participation in a collision sport negatively affects neurocognitive function,&rdquo; says<span class="apple-converted-space">&nbsp;</span><span class="xn-person">Gregory W Stewart</span>, co-director of the Sports Medicine Programme and associate professor of orthopaedics at the Tulane School of Medicine, and lead author of the study. &ldquo;The implication is that the playing of football is not in and of itself detrimental.&rdquo;&nbsp;</span></p> <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;">However, the research does &ldquo;reinforce the need to educate high school and college athletes to better understand the importance of being honest about their (concussion) symptoms so that they can be treated appropriately,&rdquo; says Stewart, who also is chief of the Division of Physical Medicine and Rehabilitation at <span class="xn-org">Tulane</span>. &ldquo;Many kids play with symptoms that they don&rsquo;t necessarily equate with a concussion.&rdquo;</span></p></div> Clinical study finds electroCore’s non-invasive vagus nerve stimulation effective in treating migraine 2014-03-17T11:38:00Z 2014-03-17T11:38:00Z <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>A study reported in the International Headache Society&rsquo;s official journal <span style="color: #800000;"><a href="" target="_blank"><span style="color: #800000;"><em>Cephalalgia</em></span></a></span> found that the use of electroCore&rsquo;s non-invasive vagus nerve stimulation therapy may be an effective and well tolerated treatment for migraine in certain patients.</strong></span></p> </div><div id="Text135" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The open label study was carried out by the University of California, USA and at four other sites in USA involving 30 patients.</span></p> <p><br /><span style="font-size: 10pt;">Of the 30 enrolled patients, 27 used the non-invasive vagus nerve stimulation therapy to treat a total of 80 migraine attacks. Patients with moderate or severe headache attacks reported pain freedom or relief in 23 out of 54 attacks (43%). This included 12 out of 54 attacks where the patients reported being pain free at two hours after treatment (22%). Additionally, in 10 of 26 attacks when the patient treated while the pain was mild, the patients reported being pain free at two hours (38 %). No unanticipated, serious or severe adverse events were reported and the paper stated that non-invasive vagus nerve stimulation seems much better tolerated than the more potent triptans and does not have comparable cardiovascular or cerebrovascular concerns.</span></p> <p><br /><span style="font-size: 10pt;">The study also found that certain patients responded positively on a consistent basis. Of 18 patients who treated at least three attacks, six were pain free on two out of three occasions (33%).</span><br /> <br /><span style="font-size: 10pt;"> ElectroCore&rsquo;s proprietary, non-invasive electrical stimulation therapy works by activating specific fibres in the vagus nerve bundle. This activation causes the release of inhibitory neurotransmitters within the central nervous system, and reduces the over expression of the excitatory neurotransmitter glutamate, which has been implicated in a number of different disorders.</span></p> <p><br /><span style="font-size: 10pt;">Patients self-treat by holding the device on their neck over the vagus nerve for two minutes. All patients are trained in the use of the device to ensure they place it correctly and they use the appropriate setting.</span></p> <p><br /><span style="font-size: 10pt;">JP Errico, chief executive officer and founder of electroCore, comments, &ldquo;We are delighted to see that this easy to use treatment was found to be effective in a substantial number of patients for this debilitating and painful condition. The authors of this report noted the need for further placebo controlled trials and we are presently carrying out four double blind randomised controlled studies in the US and Europe which will read out in the second half of this year.&rdquo;</span></p></div> Significant head and neck injury risk associated with extreme sports 2014-03-17T11:16:00Z 2014-03-17T11:16:00Z <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><span style="font-size: 11pt;"><strong>A new study presented at the 2014 Annual Meeting of the&nbsp;American Academy of Orthopaedic Surgeons&nbsp;shows that extreme sports such as snowboarding and skateboarding present high risk for head and neck injuries, including concussions. The findings support the need for greater education and advocacy efforts for safer equipment.</strong></span></p> </div><div id="Text136" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In this first-of-its-kind study, researchers reviewed 2000-2011 National Electronic Injury Surveillance System data for seven popular sports featured in the Winter and Summer X Games: surfing, mountain biking, motocross, skateboarding, snowboarding, snowmobiling and snow skiing. Data from the National Electronic Injury Surveillance System database was collected for each individual sport, and type of head and neck injury: lacerations, contusions/abrasions, fractures, sprains (neck) and concussions (head). The risk of concussion, neck fracture and skull fracture were calculated using extreme sport participation rates from the 2013 Outdoor Foundation Participation Report.</span></p> <p><br /><span style="font-size: 10pt;">Of the 4 million injuries reported for extreme sport participants, 11.3% were head and neck injuries. Of all head and neck injuries reported in extreme sports, 83% were head injuries and 17% neck injuries. The data included all ages; however, teens and young adults accounted for the highest percentage of extreme sport injuries. Other findings included:</span></p> <ul> <li><span style="font-size: 10pt;">The four sports with the highest incidence of head and neck injuries were skateboarding (129,600), snowboarding (97,527), skiing (83,313) and motocross (78,236).</span></li> <li><span style="font-size: 10pt;">Concussions were the most common head and neck injury among extreme sports participants. The risk of suffering a concussion was highest in snowboarding and skateboarding.</span></li> <li><span style="font-size: 10pt;">Skateboarders also were found to have the highest risk of skull fractures.</span></li> <li><span style="font-size: 10pt;">Surfers had the highest risk of neck fracture with a risk 38 times greater than skateboarders.</span></li> <li><span style="font-size: 10pt;">The incidence of extreme sports head and neck injuries increased from 34,065 in 2000 to 40,042 in 2010, although the trend was not consistent year-to-year.</span></li> </ul> <p><span style="font-size: 10pt;">&ldquo;The research provides a baseline to further study head and neck injuries among extreme sport participants,&rdquo; says&nbsp;Vani J Sabesan, assistant professor of orthopaedic surgery at&nbsp;Western Michigan University&nbsp;School of Medicine, and lead author of the study. &ldquo;There&rsquo;s an understanding that these sports are growing in participation, and that they can result in significant injuries.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The findings provide &ldquo;an opportunity for sports medicine and orthopaedic surgeons to advocate for safer equipment, improved on-site medical care, and further research regarding extreme sport injuries,&rdquo; says Sabesan.&nbsp;</span></p></div> Study finds high utilisation of neuroimaging for headaches despite guidelines 2014-03-17T10:57:00Z 2014-03-17T10:57:00Z <div id="ImageMain37" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction37" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A recent study has found that neuroimaging for headaches is frequently ordered by physicians during outpatient visits, despite guidelines that recommend against such routine procedures.</strong></span></p> </div><div id="Text137" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study was published in <a href="" target="_blank"><em>JAMA Internal Medicine</em></a>. The authors, Brian C Callaghan of the University of Michigan Health System, Ann Arbor, USA and colleagues, analysed National Ambulatory Medical Care Survey data for all headache visits for patients 18 years or older from 2007 through 2010.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />They found that there were 51.1 million headache visits during those four years, including 25.4 million for migraines. Neuroimaging was performed in 12.4% of all headache visits and in 9.8% of migraine visits at an estimated cost of US$3.9 billion. The use of neuroimaging has increased from 5.1% of all annual headache visits in 1995 to 14.7% in 2010.</span></p> <p><span style="font-size: 10pt;"><strong>&nbsp;</strong></span></p> <p><span style="font-size: 10pt;"><br />The authors conclude, &ldquo;Since 2000, multiple guidelines have recommended against routine neuroimaging in patients with headaches because a serious intracranial pathologic condition is an uncommon cause. Consequently, the magnitude of per-visit neuroimaging use found in this study suggests considerable overuse.&rdquo;</span></p></div> Philips celebrates World Sleep Day to raise awareness of the benefits of good sleep 2014-03-17T10:27:00Z 2014-03-17T10:27:00Z <div id="Introduction38" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>In celebration of World Sleep Day, March 14, Royal Philips announced its Sleep Powers initiative for 2014, aimed at encouraging increased awareness of and education around the benefits of sleep and the important role it plays in powering everything that we do.</strong></span></p> </div><div id="Text138" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Sleeping well is essential to good health and loss of quality of sleep can lead to numerous health problems such as hypertension, heart disease, stroke and diabetes,&rdquo; says Teofilo Lee Chiong, chief medical liaison, Philips Home Healthcare Solutions. &ldquo;The Sleep Powers initiative aims to draw more attention to the importance of a good night&rsquo;s sleep and encourages better sleep as a part of a healthy lifestyle.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In addition, Philips has launched the Sleep Power Quotient quiz, which will grade a person&rsquo;s quality of sleep based on their answers to simple sleep habit and health questions. Upon completion of the Sleep Power Quotient quiz, any individuals with results that point to poor sleep habits will then be invited to take an online risk assessment test to determine their risk level for obstructive sleep apnea (OSA), one of the most common sleep disorders, currently estimated to affect 100 million people worldwide. Those at high risk for obstructive sleep apnea will be directed to follow up with their health care provider.</span></p></div> Blood biomarkers could help guide return to play for athletes after concussion 2014-03-17T10:06:00Z 2014-03-17T10:06:00Z <div id="ImageMain39" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction39" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>In a recent study it was found that ice hockey players in Sweden with a sports-related concussion had higher levels of the blood biomarker total tau (T-tau), which suggests the central nervous system protein may be a tool for diagnosing concussions and making decisions about when players can return to play.</strong></span></p> </div><div id="Text139" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study was published recently in <em><a href="" target="_blank">JAMA Neurology</a></em>.&nbsp;Lead author is Pashtun Shahim of Sahlgrenska, University Hospital, Sweden.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to the authors, concussion or mild traumatic brain injury in athletes who play competitive contact sports, such as ice hockey, American football and boxing, is a growing problem. While mild concussions generally cause no loss of consciousness, they can induce other symptoms such as dizziness, nausea, trouble concentrating, memory problems and headaches. Severe concussions can cause a loss of consciousness. Most concussions resolve in days or weeks, but some patients can suffer symptoms more than a year after injury.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The authors examined whether sports-related concussions were associated with elevated levels of blood biochemical markers of injury to the central nervous system. Swedish Hockey League players (n=288) underwent preseason baseline examination for concussion and some underwent preseason blood testing. Of the 288 players, 35 had a sports-related concussion from September 2012 through January 2013, and 28 of those players were included in the study. Players underwent repeated blood testing in the hours and days after their injuries and when they returned to play.</span></p> <p><br /><span style="font-size: 10pt;"> The authors report that players who had concussions had increased levels of the injury biomarker T-tau compared with preseason levels. The highest levels of T-tau were measured in players during the first hour after a concussion and declined during the first 12-hour period but remained elevated six days later compared with preseason blood results. T-tau levels after concussion also were associated with the number of days it took for concussion symptoms to resolve and for players to safely return to competition.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The authors conclude: &ldquo;Plasma T-tau, which is a highly central nervous system-specific protein, is a promising biomarker to be used both in the diagnosis of concussion and in decision making as to when an athlete can be declared fit for return to play.&rdquo;</span></p></div> Stroke survivors may lose month of healthy life for 15-minute delay in treatment 2014-03-17T09:40:00Z 2014-03-17T09:40:00Z <div id="ImageMain40" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction40" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Every 15-minute delay in delivering a clot-busting drug after stroke robs survivors of about a month of disability-free life, according to a new study in the American Heart Association journal&nbsp;<span style="color: #800000;"><a href="" target="_blank"><span style="color: #800000;"><em>Stroke</em></span></a></span>.</strong></span></p> </div><div id="Text140" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">On the other hand, speeding treatment by just one minute means another 1.8 days of healthy life, researchers said.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;&lsquo;Save a minute; save a day&rsquo; is the message from our study, which examined how even small reductions in treatment delays might benefit patients measurably in the long run,&rdquo; says Atte Meretoja, lead author of the study and associate professor of neurology at the University of Melbourne in Australia.</span></p> <p><br /><span style="font-size: 10pt;">The clot-busting drug&nbsp;tissue plasminogen activator&nbsp;(tPA) to treat ischemic&nbsp;stroke, should be given within 4.5 hours of symptom onset. However, the sooner it&rsquo;s given, the better the outcome.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Clot-busting treatment works equally well, irrespective of race, ethnicity or gender,&rdquo; Meretoja says. &ldquo;Speedy restoration of blood flow to the brain is crucial for brain cell survival everywhere.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The world&rsquo;s fastest stroke services in Helsinki, Finland and Melbourne, Australia, take an average 20 minutes from hospital arrival to start of treatment, he says. Most American, Australian and European centres take 70-80 minutes.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;In this study, we wanted to quantify the importance of speed in the hope that concrete easy-to-relate-to figures will inspire medical services to measure and improve their game for the benefit of our stroke patients,&rdquo; Meretoja said.</span></p> <p><br /><span style="font-size: 10pt;">Meretoja and colleagues used evidence from the combined major clot-busting trials reported to date. They applied those findings to 2,258 consecutive stroke patients from Australia and Finland to calculate what the patient outcomes would have been if they had been treated faster or slower.</span></p> <p><br /><span style="font-size: 10pt;">They found:</span></p> <ul> <li><span style="font-size: 10pt;">For every minute the treatment could be delivered faster, patients gained an average 1.8 days of extra healthy life.</span></li> <li><span style="font-size: 10pt;">Although all patients benefited from faster treatment, younger patients with longer life expectancies gained a little more than older patients.</span></li> </ul> <p><br /><span style="font-size: 10pt;">&ldquo;In stroke treatment, every minute saved gives patients days of healthy life,&rdquo; Meretoja says. &ldquo;Patients should never wait a single minute for stroke signs, such as face droop, arm weakness or speech disturbance, to go away. They should call for help immediately. Additionally, most emergency medical services and hospitals have the ability to reduce response and treatment delays significantly, and we have described how to do this.&rdquo;</span></p></div> National campaign launched in USA to help increase diversity in clinical trials 2014-03-14T14:13:00Z 2014-03-14T14:13:00Z <div id="Introduction41" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum announced a first-of-its-kind national campaign to help increase diversity in clinical trials.</strong></span></p> </div><div id="Text141" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, the&nbsp;&ldquo;I&rsquo;m In&rdquo;&nbsp;campaign will raise awareness about the importance of clinical research and encourage greater participation by diverse patient populations to help researchers develop potential new life-saving medicines. Partnerships with patient advocacy organisations, provider groups, individual physicians, clinical trials sponsors and researchers will help to drive campaign awareness and involvement.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;PhRMA and our member companies are committed to raising awareness and increasing participation in clinical trials, particularly among historically underrepresented populations,&rdquo; says&nbsp;John Castellani, president and chief executive officer of PhRMA. &ldquo;Through this collaboration of health care leaders, we are taking a major step forward to help reduce health disparities through greater inclusiveness in clinical research.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Developing new medicines is a lengthy and complex process, relying heavily on volunteer participation to evaluate potential therapies for safety and effectiveness in clinical studies. Without the patients who volunteer to participate in clinical trials, the development of new medicines would not be possible.</span></p> <p><br /><span style="font-size: 10pt;">However, groups such as African Americans, Asian Americans and Hispanics are significantly underrepresented in clinical research.&nbsp;According to the Food &amp; Drug Administration (FDA), African Americans represent 12% of the U.S. population but only 5% of clinical trial participants and Hispanics make up 16% of the population but only 1% of clinical trial participants. Inclusion of individuals of varied races, ethnicities, ages, gender and sexual orientation in clinical trials can help to prevent disparities in the evaluation of potential new medicines.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;According to the FDA, increased diversity in clinical trials could help researchers find better ways to fight diseases that disproportionately impact certain populations, and may be important for the safe and effective use of new therapies,&rdquo; says&nbsp;Gary Puckrein, president and chief executive officer of the National Minority Quality Forum. &ldquo;Through the&nbsp;&ldquo;I&rsquo;m In&rdquo;<strong>&nbsp;</strong>campaign, new online resources such as the Clinical Trial Engagement Network will be introduced to empower individuals to learn more about clinical trials and the benefits of participating in clinical research.&rdquo;</span></p></div> Enrolment begins in a second phase II study of ND0612 for the treatment of Parkinson&apos;s disease 2014-03-12T11:34:00Z 2014-03-12T11:34:00Z <div id="Introduction42" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>NeuroDerm announced that enrolment of patients is ongoing in its second phase II clinical trial of ND0612, a novel drug formulation for the treatment of Parkinson&rsquo;s disease. ND0612 is a proprietary levodopa/carbidopa liquid formulation under development for continuous subcutaneous administration through a patch pump. It is designed to provide steady levodopa blood levels for the treatment of Parkinson&rsquo;s disease.</strong></span></p> </div><div id="Text142" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a company release, in previous <a href=";rank=2" target="_blank"><strong>phase I and phase IIa studies</strong></a>, ND0612 was shown to be safe and tolerable and reached steady state, clinically meaningful levodopa concentrations. Furthermore, it was demonstrated that the levodopa concentrations could be preset to reach different day and night levels. The current Phase II double-blind, randomised placebo controlled study in Parkinson&rsquo;s disease patients will assess ND0612 in 30 Parkinson&rsquo;s disease patients over a period of 21 days for safety, tolerability, levodopa and carbidopa steady state plasma levels, and exploratory clinical parameters. This trial is supported by a grant of&nbsp;US$1 million&nbsp;by The Michael J Fox Foundation for Parkinson&rsquo;s Research, the second&nbsp;US$1 million&nbsp;grant from the Foundation to NeuroDerm&rsquo;s continuous SC administration dopaminergic programme.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Following its success in earlier phase I and phase IIa trials, ND0612 is now entering more advanced phase II trials in patients. An important objective of this study will be to asses longer term steady state levodopa concentrations in patients and obtain a first impression of their effect on the patients&rdquo; says&nbsp;Oded S Lieberman, NeuroDerm&rsquo;s chief executive officer. &ldquo;ND0612 bypasses the gastrointestinal tract, should not be influenced by intestinal absorption or oral ingestion of food or drugs, and is administered in a controlled, predetermined rate both day and night<em>&mdash;</em>a treatment mode that has not been available to date to Parkinson&rsquo;s patients. This trial marks an important step in the development of ND0612 that could become a breakthrough treatment option for Parkinson&rsquo;s disease patients.&rdquo;</span></p></div> 24-month data show back and leg pain scores are reduced with the Senza spinal cord stimulation system 2014-03-12T10:30:00Z 2014-03-12T10:30:00Z <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>Nevro Corp has announced that the 24-month results of a prospective European clinical study using Nevro&rsquo;s Senza&nbsp;system delivering HF10 therapy were published in the journal&nbsp;<em>Pain Medicine</em>. The study was conducted in the&nbsp;UK and&nbsp;Belgium&nbsp;with 65 of the 72 implanted patients (90%) being available for data collection at two years.</strong></span></p> </div><div id="Text143" style="clear:both; text-align:left"><p style="line-height: 15.0pt; background: white; margin: 0cm 0cm 7.5pt 0cm;"><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 10pt;">This clinical study evaluated the long-term safety and efficacy of HF10 therapy in patients with difficult-to-treat chronic, retractable low-back and leg pain. At baseline, 86% of the patients included in the 24-month analysis had primary back pain and 79% had failed back surgery syndrome. After two years of HF10 therapy, the mean baseline back pain score of 8.4 out of 10 was reduced to 3.3 (p&lt;0.001). The mean baseline leg pain score of 5.4 out of 10 was reduced to 2.3 (p&lt;0.001). The mean dosage of oral morphine equivalents per patient decreased from 84mg/day to 27mg/day (p&lt;0.001). Disability and sleep disturbances were also significantly reduced. The safety profile of HF10 therapy was comparable to traditional spinal cord stimulation in terms of type and rates of complications.</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="box-sizing: border-box; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="color: #333333;"><br /> The Senza system is presently the subject of the <a href=";rank=1" target="_blank"><strong>SENZA-RCT</strong></a> pivotal study, a landmark prospective, randomised, controlled study in<span class="apple-converted-space">&nbsp;<span class="xn-location">the USA&nbsp;</span></span>to evaluate the safety and efficacy of Nevro&rsquo;s Senza system in patients with chronic pain. The SENZA-RCT study is the first pivotal randomised, controlled trial in the history of spinal cord stimulation and the only randomised study with a head-to-head comparison of spinal cord stimulation systems.<span style="box-sizing: border-box;"><span class="apple-converted-space">&nbsp;</span></span>Nevro announced completion of enrolment in the study in<span class="apple-converted-space">&nbsp;<span class="xn-chron">March 2013</span></span>, with 241 patients enrolled over a seven-month period at 11 leading pain centres across<span class="apple-converted-space">&nbsp;<span class="xn-location">the USA</span></span>. Patients were randomised to receive either the Senza system or a traditional low-frequency spinal cord stimulation system.</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; font-family: arial, helvetica, sans-serif;"><strong style="box-sizing: border-box;"><span style="box-sizing: border-box;"><span style="color: #333333;"><br /> </span></span></strong><span style="color: #333333;">Nevro&rsquo;s Senza system delivers HF10 therapy, a spinal cord stimulation therapy that provides electrical pulses to the spinal cord at a rate up to 10,000 per second (10 kHz), as compared to traditional low-frequency spinal cord stimulation therapy, which usually deliver the electrical pulses at less than 100 pulses per second for chronic back and leg pain. The electrical pulses are conveyed by small electrodes placed in the epidural space and connected to a compact battery-powered generator implanted under the skin. The Senza system utilises a rechargeable battery and has achieved a CE Mark labelling for a 10 year battery life.</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="box-sizing: border-box; font-size: 10pt; font-family: arial, helvetica, sans-serif;"><span style="color: #333333;"><br /> The Senza system is authorised for sale in<span class="apple-converted-space">&nbsp;<span class="xn-location">Europe</span></span><span class="apple-converted-space">&nbsp;</span>and<span class="apple-converted-space">&nbsp;<span class="xn-location">Australia</span></span><span class="apple-converted-space">&nbsp;</span>and is supported by European data published in<span class="apple-converted-space">&nbsp;</span><a href="" target="_blank"><em style="box-sizing: border-box;">Pain Medicine</em></a><span class="apple-converted-space">&nbsp;</span>and<span class="apple-converted-space">&nbsp;</span><a href="" target="_blank"><em style="box-sizing: border-box;">Neuromodulation: Technology at the Neural Interface</em></a>. In<span class="apple-converted-space">&nbsp;<span class="xn-location">the USA</span></span>, the system is limited by federal law to investigational use only and is not available for sale.</span></span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">&nbsp;</span></p></div> SMC says yes to Aubagio (teriflunomide) 2014-03-11T09:37:00Z 2014-03-11T09:37:00Z <div id="ImageMain44" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction44" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Scottish Medicines Consortium (SMC) has published its advice that Aubagio (teriflunomide) 14 mg tablets have been accepted for use by NHS Scotland for the treatment of adults with relapsing remitting multiple sclerosis, as an alternative to the currently available treatment options beta interferon or glatiramer acetate. The guidance does not include patients with highly active multiple sclerosis.</strong></span></p> </div><div id="Text144" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The prevalence of multiple sclerosis in Scotland is one of the highest in the world, so the approval of Aubagio as another treatment option will be welcomed by the Scottish multiple sclerosis community. Aubagio is an oral drug, taken once daily and this makes it an exciting development both for people with multiple sclerosis and their clinicians, providing more choice and an alternative to injections. This is a really positive development for the future of treatment for relapsing remitting multiple sclerosis,&rdquo; comments Amy Bowen, director of Service Development at the Multiple Sclerosis Trust.</span><br /><br /><span style="font-size: 10pt;">The guidance published by the SMC represents an important step in improving the standard of care available to people with the disease. &ldquo;Multiple sclerosis is a real concern in Scotland as it is a debilitating disease which has a high prevalence. This is good news for people with multiple sclerosis in Scotland and a significant milestone in improving the care of multiple sclerosis patients here,&rdquo; says Belinda Weller, consultant neurologist, Western General Hospital, Edinburgh, Scotland.</span><br /><br /><span style="font-size: 10pt;">Aubagio is the first medicine in Genzyme&rsquo;s pipeline of multiple sclerosis therapies to receive final SMC guidance and become available to patients in Scotland.</span><br /><br /><span style="font-size: 10pt;">Aubagio is an immunomodulator with anti-inflammatory properties. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is not fully understood, but this is mediated by a reduced number of lymphocytes.&nbsp; Aubagio is supported by an extensive multicentre, multicountry clinical programme, with more than 2,700 trial participants.&nbsp; Some patients in extension trials have been treated for up to 8.5 years.</span></p></div> Flow diverters safe and feasible in ruptured blood blister-like aneurysms 2014-03-10T17:05:00Z 2014-03-10T17:05:00Z <div id="ImageMain45" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction45" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Published in the<a href="" target="_blank"><em> Journal of NeuroInterventional Surgery</em></a>, the results of a small study of 11 patients has demonstrated that Silk flow diverter stents (Balt Extrusion) could be a safe and feasible treatment for fragile, difficult-to-treat blood blister-like aneurysms.</strong></span></p> </div><div id="Text145" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Kubilay Aydin, department of Radiology, Istanbul Faculty of Medicine, Istanbul, Turkey and colleagues say that blood blister-like aneurysms are associated with high morbidity and mortality surgical and endovascular methods such as clipping, clip wrapping, primary coiling, stent-assisted coiling.</span><br /><br /><span style="font-size: 10pt;">With respect to this, the authors retrospectively reviewed patients who presented with subarachnoid haemorrhage caused by ruptured blood blister-like aneurysms who were treated with flow diverters.</span></p> <p><span style="font-size: 10pt;">Out of the 11 patients, nine were found to have blood blister-like aneurysms in the supraclinoid carotid artery and two in the basilar artery. Eight patients were treated with one flow diverter stent and two flow diverter stents were telescopically deployed in three patients.</span><br /><br /><span style="font-size: 10pt;">The authors report that there were no acute complications in any of the cases. However, one patient died of septicaemia two weeks postprocedure (9%) and another had a minor stroke caused by parent artery thrombosis (9%).</span><br /><br /><span style="font-size: 10pt;">At three and six months post stenting, control angiographies showed that there was complete occlusion of the aneurysms in all nine remaining patients (82%). Ten of the 11 patients (92%) had good clinical outcomes as measured by Modified Rankin Scale score of &le;2.</span><br /><br /><span style="font-size: 10pt;">In their conclusion, Aydin <em>et al</em> say that flow diverter stent implantation in this small experience seemed to be a &ldquo;safe and feasible alternative for the treatment of ruptured blood blister-like aneurysms.&rdquo;</span></p></div> Phase III GBM brain cancer trial gets recommendation to continue based on Data Safety Monitoring Board&apos;s safety review 2014-03-10T10:25:00Z 2014-03-10T10:25:00Z <div id="Introduction46" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Northwest Biotherapeutics, a biotechnology company developing DCVax personalised immune therapies for solid tumour cancers, has announced, in response to shareholder inquiries, that the Data Safety Monitoring Board (DSMB) has made an unblinded review of the safety data for the company&rsquo;s ongoing international phase III glioblastoma multiforme (GBM) trial, and has recommended that the trial continue as planned.</strong></span></p> </div><div id="Text146" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The DSMB&rsquo;s review of the efficacy data is still pending. &nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Marnix Bosch, chief technical officer of Northwest Biotherapeutics notes, &ldquo;We are pleased with the recommendation of the DSMB to continue the trial as planned. This is an important step in the ongoing progress of our phase III trial.&rdquo;</span></p></div> Reducing wait times could improve spinal cord stimulator success for chronic pain 2014-03-07T16:30:00Z 2014-03-07T16:30:00Z <div id="ImageMain47" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction47" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Success rates soared to 75% for patients who waited less than two years for a spinal cord stimulator implant, compared with 15% for patients whose who received implants 20 years after the onset of pain, according to a retrospective analysis. The length of time patients waited for a referral also varied by specialty, as shown in a scientific poster presented at the 30th Annual Meeting of the American Academy of Pain Medicine.</strong></span></p> </div><div id="Text147" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study authors placed their findings in context by noting that fewer than 50% of patients currently report long-term success with spinal cord stimulator in the treatment of chronic pain. Improving wait times could significantly improve success rates, says lead author Krishna Kumar, Regina General Hospital in Regina, Saskatchewan, Canada.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The success of spinal cord stimulation is time sensitive, in that as wait times decline, long-term outcomes with spinal cord stimulation are enhanced,&rdquo; Kumar says.</span></p> <p><br /><span style="font-size: 10pt;">Kumar cites barriers to referral that included lack of uptake and awareness among healthcare providers, patients and payers; ongoing reimbursement concerns; and fragmentation of pain-care delivery. Moreover, Kumar cites return to employment as a metric that has been unfairly employed to curtail access to spinal cord stimulation, a tactic he said downplays benefits of spinal cord stimulation for quality of life, pain and depression.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study included 443 patients who received spinal cord stimulators. Beginning with the initial pain diagnosis, investigators examined points of delay to referral for implantation by primary care physicians and specialists. The effects on pain duration of gender, age, referring specialty, and their interactions were analysed using a two-way ANOVA. A multiple linear regression model that incorporated patient demographic characteristics and components of wait times was developed to predict factors responsible for delays in spinal cord stimulator implantation.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Patients first saw a physician an average of 3.4 months after developing a pain syndrome. Family physicians managed patients for 11.9 months. Specialists then took over management for an additional 39.8 months on average.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The mean time to implantation from symptom onset was 5.12 years. Neurosurgeons were quickest to make a referral, whereas, non-implanting anaesthetists were most likely to delay implantation. In fact, referral for spinal cord stimulator treatment took 2.15 years longer if a non-implanting anaesthetist vs. a neurosurgeon referred the patient.</span></p></div> Aethlon Medical and Exosome Sciences announce brain research discoveries 2014-03-07T09:30:00Z 2014-03-07T09:30:00Z <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>Aethlon Medical and Exosome Sciences have announced that its researchers have successfully isolated brain-specific biomarkers associated with a variety of neurodegenerative disorders. According to a release, the discoveries could have implications in the diagnosis, monitoring and treatment of Alzheimer&rsquo;s disease, chronic traumatic encephalopathy and traumatic brain injury.&nbsp;</strong></span></p> </div><div id="Text148" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a company release, the research studies provide evidence that exosomes can serve as a &ldquo;liquid biopsy&rdquo; to diagnose neurologic conditions. While exosomes from the central nervous system have previously been identified in the cerebrospinal fluid, the Aethlon-Exosome Sciences study identified exosomes carrying brain-specific markers tau, beta-amyloid, glycoprotein A2B5 and S100B protein in the peripheral circulation of affected individuals. The discoveries provide a basis for an exosome-based platform that could enable the simultaneous identification of multiple brain specific markers that are transported across the blood-brain barrier and into the circulatory system.</span><br /><br /><span style="font-size: 10pt;">&ldquo;This advancement represents a new paradigm for brain injuries. In addition to providing definitive diagnosis, the proteomic and transcriptomic characterisation of exosomes isolated specifically from the brain will provide a window into the molecular mechanisms underlying acute and chronic brain injuries,&rdquo; says Exosome Sciences chief scientific officer, Douglas Taylor.</span><br /><br /><span style="font-size: 10pt;">As a result of the discoveries, brain-derived exosomes can be specifically isolated and the protein and RNA cargoes identified. In studies of brain tissue, specific RNAs have been associated with development of neurological disorders, contributing to the onset and progression of brain injuries. Exosomal RNA and protein cargoes represent surrogates to brain biopsies and have utility as stable, clinically accessible biomarkers for brain injury detection, stratification of patients and therapeutic outcomes.</span><br /><br /><span style="font-size: 10pt;">&ldquo;With the exosome-based technologies developed by our group, we are at the verge of breakthroughs for the management and treatment of brain injuries and diseases that have been associated with disability and death,&rdquo; says Cicek Gercel-Taylor, clinical research director at Exosome Sciences.</span><br /><br /><span style="font-size: 10pt;">Circulating biomarkers have been proposed for the definitive diagnosis and monitoring treatment of brain injuries. The approach would enable diagnosing the condition, identifying processes that are difficult to image, monitoring responses to interventions, and predicting those who are at risk for long-term neurologic consequences. However, circulating biomarkers, such as free protein and nucleic acids, are extremely unstable in circulation. Therefore, a high steady-state must be reached for detection, which is generally not observed except in severe cases. To circumvent these issues, exosome-associated biomarkers can be utilised as they are stable and detectable in the circulation.</span></p></div> New published paper shows efficacy of Lpathomab in traumatic brain injury models 2014-03-05T16:01:00Z 2014-03-05T16:01:00Z <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><span style="font-size: 11pt;"><strong>Lpath, according to a company release, has brought scientists one step closer to finding a potential treatment for traumatic brain injury with a recent publication showing that Lpathomab, an anti-lysophosphatidic acid antibody, reverses much of the damage caused by trauma to the nervous system.</strong></span></p> </div><div id="Text149" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">As published by the <a href="" target="_blank"><strong>Journal of Neuroinflammation</strong></a> (vol 11, article 37), Lpathomab can be used to reduce the size of a traumatic brain injury and to improve functional behavioural outcomes in experimental animal models. The antibody works as a molecular sponge by soaking up lysophosphatidic acid, a molecule that can damage neurons and promote dangerous inflammatory responses in the central nervous system.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">In collaboration with scientists at the University of Melbourne, the antibody was tested in mice that had traumatic brain injuries. A key finding of the study was the significant efficacy of administering Lpathomab after an injury, thus demonstrating a potential therapeutic benefit. Also shown for the first time in this paper was that human patients with traumatic brain injury exhibited substantial increases in the levels of lysophosphatidic acid in the cerebrospinal fluid after injury, a finding also seen in the injured mouse model of traumatic brain injury; such data suggest that lysophosphatidic acid is a valid target for therapeutic intervention.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Lpath and its Melbourne collaborators have recently shown that Lpathomab provides protection against neuronal cell death and scarring in experimental models of spinal cord injury, published recently in the <a href="" target="_blank"><strong>American Journal of Pathology</strong></a> (Goldschmit <em>et al</em>, vol 181,&nbsp;978-992). Currently, there are no FDA-approved drugs for the treatment of neurotrauma such as traumatic brain injury and spinal cord injury.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;This research provides new hope for therapeutic treatments for many forms of neurotrauma, including traumatic brain injury and spinal cord injury as well as other forms of neurodegenerative disorders,&rdquo; says Roger Sabbadini, vice president and founder of Lpath and co-author on the paper. &ldquo;We believe that lysophosphatidic acid may be a biomarker that could be used to aid in the diagnosis of traumatic brain injury, as the &rsquo;lysophosphatidic acid pulse&rsquo; that occurs in the injured brain can also be detected in blood.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">The research team was comprised of Lpath scientists and collaborators from the University of Melbourne, Monash University and the University of Kentucky.</span></p></div> Forest Laboratories submits new drug application for memantine extended release and donepezil fixed-dose combination for Alzheimer’s disease 2014-03-05T13:03:00Z 2014-03-05T13:03:00Z <div id="Introduction50" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Forest Laboratories and Adamas Pharmaceuticals announced Forest&rsquo;s submission of a new drug application to the US Food and Drug Administration for a fixed-dose combination of memantine HCl extended release and donepezil HCl for the treatment of moderate to severe dementia of the Alzheimer&rsquo;s type.</strong></span></p> </div><div id="Text150" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The concurrent use of memantine and donepezil is a well-established treatment option for patients with moderate to severe dementia related to Alzheimer&rsquo;s disease. Using the two drugs together appears to provide benefit over using acetylcholinesterase inhibitors alone. Reducing the number of pills by offering patients a fixed-dose combination helps lessen the daily medication burden and could improve patient adherence and compliance,&rdquo; says Pierre Tariot, at the Banner Alzheimer&rsquo;s Institute, who has also consulted for both Adamas and Forest.</span></p> <p><br /><span style="font-size: 10pt;">The memantine extended release-donepezil HCl fixed-dose combination is a once-daily oral capsule for patients currently taking memantine (10mg twice daily or 28mg extended release once-daily) and donepezil 10mg. In addition, the capsules can be opened to allow the contents to be sprinkled on applesauce to facilitate dosing for patients who may have difficulty swallowing.</span></p> <p><br /><span style="font-size: 10pt;">The new drug application consisted of two dosage strengths, 28mg/10mg (memantine extended release/donepezil) and 14mg/10mg (memantine extended release/donepezil) for patients with severe renal impairment. Memantine ER is the active ingredient in the currently marketed Namenda XR, which is indicated for the treatment of moderate to severe dementia of the Alzheimer&rsquo;s type. Donepezil is the active ingredient in aricept, which is indicated for the treatment of mild to severe dementia of the Alzheimer&rsquo;s type. Forest and Adamas collaborated on the development of the fixed-dose combination and Forest will have exclusive US commercialisation rights while Adamas will retain exclusive commercialisation rights outside of the USA.</span></p></div> US clinical site opens for expansion of CEL-SCI’s global phase III immunotherapy head and neck cancer trial 2014-03-05T12:50:00Z 2014-03-05T12:50:00Z <div id="Introduction51" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>CEL-SCI Corporation announced its phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, injection) has activated its first US clinical trial expansion site at&nbsp;21st Century Oncology&nbsp;in Greenville, North Carolina, USA. The trial is already active in dozens of hospitals and clinical centres in 12 countries.</strong></span></p> </div><div id="Text151" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, 21st Century Oncology is the largest global, physician-led provider of integrated cancer care services, operating 166 treatment centres, with 133 centres in 16 US&nbsp;states and 33 centres in six Latin American countries. The Greenville, North Carolina facility is led by Ron Allison, a board-certified radiation oncologist specialising in head and neck cancer. Allison, who is serving as the principal investigator of CEL-SCI&rsquo;s phase III study at the site, has authored several books in the field of oncology and holds several patents addressing radiation isometer measurement devices/visualisation and ultrasound distance measurement devices.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Our goal is to have between 10 and 15 US clinical centres participating in our phase III trial. We should be there by this summer.&rdquo; says CEL-SCI chief executive officer, Geert Kersten.</span></p> <p><br /><span style="font-size: 10pt;">Multikine (Leukocyte Interleukin, injection) is an immunotherapeutic agent that is being tested in a randomised, controlled, global pivotal phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI&rsquo;s clinical development programme for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body&rsquo;s natural immune system in the fight against tumours. CEL-SCI is aiming to complete enrolment of subjects to the phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 to 110 clinical centres in about 20 countries.</span></p></div> D-Pharm reports successful interim analysis of phase II clinical study 2014-03-05T12:25:00Z 2014-03-05T12:25:00Z <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>D-Pharm has announced the successful interim analysis of the first group of stroke patients that completed follow-up in the phase II clinical study of THR-18. According to a company release, the interim report confirms the safety and tolerability of THR-18 at a dose of 0.18mg/kg, administered together with tissue plasminogen activator (tPA) in acute ischaemic stroke patients. The interim report gives a green light to proceed to recruit the second group of patients for treatment with THR-18 at a higher dose level.</strong></span></p> </div><div id="Text152" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">THR-18 is novel drug-candidate designed to reduce or neutralise the life-threatening adverse effects of tPA, such as intracranial haemorrhage and brain oedema. The current study is the first double-blind, placebo-controlled, escalating single-dose, phase IIa study to assess the safety, pharmacokinetics, and pharmacodynamics of THR-18 in acute ischaemic stroke patients treated with tPA.</span></p> <p><br /><span style="font-size: 10pt;">Gilad Rosenberg, D-Pharm&rsquo;s vice president for Clinical Development comments: &ldquo;It is reassuring to see that safety and tolerability of the first dose of THR-18 has been confirmed. It enables us to move forward and test the higher dose of 0.54mg/kg in stroke patients treated with tPA.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />THR-18 corresponds to a fragment of plasminogen activator inhibitor-1 (PAI-1), a natural inhibitor of tPA activity. THR-18 binds at one of the PAI-1 docking sites on tPA that leaves tPA&rsquo;s catalytic activity intact. THR-18 binding uncouples the clot-dissolving properties of tPA from its deleterious non-fibrinolytic effects on the blood vessel wall, including intracranial haemorrhage and brain oedema.</span></p></div> Stroke patients treated at stem cell research centre 2014-03-05T12:12:00Z 2014-03-05T12:12:00Z <div id="ImageMain53" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction53" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Stem cell research institute of STC Life and&nbsp;97.7 B&amp;H Clinic successfully completed mesenchymal stem cell treatment for stroke patients.</strong></span></p> </div><div id="Text153" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, 97.7 B &amp; H Clinic&nbsp;intravenously injected&nbsp;stem cells&nbsp;to stroke patients five times at intervals of two weeks.&nbsp;Mesenchymal stem cells, one of the adult stem cells, are widely used for tissue regeneration. Stem Cell Research Treatment Centre of STC Life gathered and used some stem cells from foetal umbilical cord.</span></p> <p><br /><span style="font-size: 10pt;">Patients who received stem cell treatment significantly reduced the symptoms of paralysis such as speech impairment, and arms and legs paralysis. Also, the patients who were chair bound were able to walk without a walking frame after second treatment.</span></p> <p><br /><span style="font-size: 10pt;">In addition, some patients&rsquo; language skills were improved by more than 90%. In the case of facial nerve paralysis, after three months treatment, some patients recovered their impairment by 80%. Some patients who had difficulty closing their eyes and speaking due to mouth droop could close their eyelids to 80% of their normal conditions, and the other patients have softened and eased movement of their lips after the treatment. </span><br /><br /><span style="font-size: 10pt;">Also, some patient&rsquo;s wrinkles around their mouth were flattened and some patients with dry mouth could facilitate movement of their faces. All of these improvements in symptoms were achieved with no side effects, the press release adds.</span></p> <p><br /><span style="font-size: 10pt;">STC Life chairman, Kye Ho Lee, says: &ldquo;We have been successfully carrying out stem cell therapy for the various diseases such as Parkinson&rsquo;s disease, autoimmune disorders, anaemia, brain disorders, etc. Stem cells collected from STC Life Research Institute are known as adult stem cells that present in the body tissues and organs, thus maintaining the function of normal cells and the regeneration of damaged tissues in the human organs and enabling a variety of growth and differentiation in the human organs.&rdquo;</span></p></div> Study shows that teenagers treated for headaches were prescribed opioids almost half of the time 2014-03-04T15:14:00Z 2014-03-04T15:14:00Z <div id="ImageMain54" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction54" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Clinicians prescribed opioids for almost half of the teenagers they treated for headache when medications, such as aspirin, ibuprofen and naproxen, are recommended as first-line therapies, according to a study in the&nbsp;<em><span style="color: #808080;"><a href="" target="_blank"><span style="color: #808080;">Journal of Adolescent Health</span></a></span>.</em></strong></span></p> </div><div id="Text154" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, the study was conducted by WellPoint and HealthCore, the outcomes research subsidiary for WellPoint, in conjunction with representatives selected by the American Academy of Paediatrics, American Academy of Family Physicians and American Academy of Neurology. The study included 8,373 adolescents from 13 to 17 years of age with recurring headaches.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Paediatric and adolescent use of opioids is a concern,&rdquo; says Eric Wall, past chair of the American Academy of Family Physicians&rsquo; Commission on Science. &ldquo;The risk of abuse, as well as the potential for redirection, such as sharing with others, is high among adolescents.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Forty-six percent of those complaining of headache received an opioid prescription. Of those who received a prescription, nearly half &ndash; or 48% &ndash; received only one prescription, while 23% received two prescriptions and 29% received three or more prescriptions.</span></p> <p><br /><span style="font-size: 10pt;">Opioids, while effective in relieving pain, are not effective for treating migraine and the American Academy of Neurology states opioids should be used only as rescue therapy for acute migraine in specific situations. Medical guidelines recommend nonsteroidal anti-inflammatory drugs or triptans as first-line therapy. Also, other studies have suggested that opioid use may contribute to the development of chronic daily headache in patients with episodic migraine and may actually prevent reversal of the migraine process.</span></p> <p><br /><span style="font-size: 10pt;">Teenagers with visits for headache to the emergency department had twice the rate of opioid prescriptions as those who had not visited the emergency department. And, those who had three or more emergency department visits were four times more likely to have opioid prescriptions.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;However, the study contrasted with previous studies primarily focused on adult populations, which have suggested that patients seeking emergency treatment for headache may be seeking narcotics,&rdquo; says lead author Andrea DeVries, HealthCore director of payer and provider research. &ldquo;On teenagers&rsquo; first visits to the emergency department, most of them had no recent history of opioid prescription.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Opioids &ndash; such as morphine, codeine, and oxycodone &ndash; are commonly prescribed to alleviate pain, however there have been increasing concerns regarding physical dependence and addiction. Other studies have found that prescription opioid abuse is the fastest growing form of drug abuse, however there is controversy regarding the level of risk for dependence in the general population.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;One goal in doing this research, and based on the American Academy of Paediatrics&rsquo; input was to examine how the actual practice patterns for treating paediatric headache were following American Academy of Neurology guidelines,&rdquo; says Alan Rosenberg, WellPoint vice president for medical policy. &ldquo;The general impression was that opioid prescriptions for this population would be low. When the results were obtained, we all felt it important to share this information with physicians and build awareness of the issue.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The study showed much higher rates of opioid prescription than rates of around 12% that had been reported previously.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;We used both medical and pharmacy claims in our data gathering, which allowed for a more comprehensive capture of prescription drug use than medical record or facility-based studies,&rdquo; said DeVries. &ldquo;Based on this work, we believe previous studies may have underreported prescription rates.&rdquo;</span></p></div> Public to get a glimpse into cutting edge brain research 2014-03-04T15:01:00Z 2014-03-04T15:01:00Z <div id="ImageMain55" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction55" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>University of Leicester scientists are making huge strides in increasing our knowledge of the brain as well as neurological disorders which affect millions of people worldwide. Now, members of the public can get a first-hand look into their fascinating research for Brain Awareness Day on Wednesday, 12 March.</strong></span></p> </div><div id="Text155" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The day forms part of the Brain Awareness Week &ndash; a global campaign to increase public awareness of the progress and benefits of brain research organised by philanthropic organisation the Dana Foundation.</span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> University researchers from a range of academic disciplines will share their latest findings in a series of talks from 6pm to 8pm in the Frank &amp; Katherine May Lecture Theatre, Henry Wellcome building, Lancaster Road.</span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> Organisers hope the evening will help the public make informed health-related decisions and will also give an insight into brain research performed day-to-day at University of Leicester. </span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> The evening will include demonstrations of methods and equipment used for understanding how the brain works, and the public will be able to talk to postgraduate researchers about their current work.</span><br /><span style="font-size: 10pt;"> &nbsp;</span><br /><span style="font-size: 10pt;"> Topics will include:&nbsp;</span></p> <ul> <li><span style="font-size: 10pt;">&lsquo;The neuroscience behind how we are able to see and remember&rsquo;, a talk by Rodrigo Quian Quiroga, of the Centre for Systems Neuroscience &nbsp;</span></li> </ul> <ul> <li><span style="font-size: 10pt;">&lsquo;The small bubbles of thought that won a Nobel Prize&rsquo;, by Vincenzo Marra, of the Department of Cell Physiology &amp; Pharmacology&nbsp;</span></li> </ul> <ul> <li><span style="font-size: 10pt;">&lsquo;Relating genes to brain diseases and remedies&rsquo;, presentation by Ruth Luthi-Carter, of the Department of Cell Physiology &amp; Pharmacology&nbsp;</span></li> </ul></div> Phase I/II clinical trial for ITI-007 in healthy geriatric subjects and patients with dementia inititated 2014-03-04T14:01:00Z 2014-03-04T14:01:00Z <div id="Introduction56" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Intra-Cellular Therapies announced the initiation of ITI-007-200, a Phase I/II clinical trial designed to evaluate the safety, tolerability and pharmacokinetics of low doses of its lead drug candidate, ITI-007, in healthy geriatric subjects and in patients with dementia, including Alzheimer&rsquo;s disease. According to a company release, the commencement of this study marks an important milestone in the strategy to develop low doses of ITI-007 for the treatment of behavioural disturbances associated with dementia and related disorders.</strong></span></p> </div><div id="Text156" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The ITI-007-200 trial is planned to be conducted in two parts. Part 1 is a randomised, double-blind, placebo-controlled multiple ascending dose evaluation of ITI-007 in healthy geriatric subjects. In each cohort in Part 1, it is anticipated that 10 subjects will be randomised to receive ITI-007 (N=8) or placebo (N=2) for seven days. In Part 2, it is anticipated that 12 patients with dementia will be randomised to receive ITI-007 (N=9) or placebo (N=3) for seven days. The number of cohorts in each part may be adjusted based on results. Safety, tolerability and pharmacokinetic data will be determined. Exploratory pharmacodynamic endpoints will be included to assess feasibility of measuring agitation, sedation, sleep and cognition in potential future trials. It is expected that initial data from the trial will be available in the second half of 2014.</span></p> <p><br /><span style="font-size: 10pt;">The press release reports that in pre-clinical and clinical trials to date, ITI-007 combines potent serotonin 5-HT2A receptor antagonism, dopamine receptor phosphoprotein modulation, glutamatergic modulation and serotonin reuptake inhibition into a single drug candidate. At dopamine D2 receptors, ITI-007 has been demonstrated to have dual properties and to act as both a post-synaptic antagonist and a pre-synaptic partial agonist. ITI-007 has also been demonstrated to stimulate phosphorylation of glutamatergic NMDA NR2B, or GluN2B, receptors in a mesolimbic specific manner.</span></p></div> Pitavastatin reduces frequency of periprocedural ischaemic complications with carotid stenting 2014-02-27T10:44:00Z 2014-02-27T10:44:00Z <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>According to the results of a study: &ldquo;Effect of pitavastatin on preventing ischaemic complications with carotid artery stenting&rdquo; (EPOCH-CAS), pretreatment with pitavastatin significantly reduces the frequency of periprocedural ischaemic complications with carotid artery stenting. The findings of EPOCH-CAS were published in <em>Cardiovascular and Interventional Radiology</em>.</strong></span></p> </div><div id="Text157" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In the multicentre, prospective EPOCH-CAS study, the included patients with carotid artery stenosis (symptomatic &ge;50%, asymptomatic &ge;80%) and a high risk of carotid endarterectomy, but no previous statin treatments. According to the authors (Katsutoshi Takayama, department of Radiology and Interventional Neuroadiology, Ishinkai General Hospital, Japan, and colleagues), the patients were divided into two groups by low-density lipoprotein cholesterol levels. </span><br /> <br /><span style="font-size: 10pt;"> With low-density lipoprotein cholesterol levels &ge;120mg/dl, the pitavastatin-treated group received pitavastatin at 4mg/day. With low-density lipoprotein cholesterol levels ˂120mg/dl, the non-pitavastatin-treated group received no statin therapy.</span></p> <p><span style="font-size: 10pt;"><br />After four weeks both groups underwent carotid artery stenting. Frequencies of new ipsilateral ischaemic lesions on diffusion-weighted imaging within 72 hours after carotid artery stenting and cereobrovascular events (transient ischaemic attack, stroke or death) within 30 days were assessed.</span></p> <p><br /><span style="font-size: 10pt;">Among 80 patients enrolled, 61 patients (pitavastatin-treated group, n=31; non-pitavastatin-treated group, n=30) fulfilled the inclusion criteria. New ipsilateral ischaemic lesions were identified in eight of 31 patients (25.8%) in the pitavastatin-treated group and in 16 of 30 patients (53.3%) in the non-pitavastatin-treated group. Cerebrovascular events occurred in no patients in the pitavastatin-treated group and in three of 30 patients (10%) in the non-pitavastatin-treated group. <br /><br />Multivariate analyses demonstrated the pitavastatin treatment to be an independent factor for decreasing post-carotid artery stenting lesions.</span></p> <p><br /><span style="font-size: 10pt;">The authors therefore conclude that during the EPOCH-CAS study, pretreatment with pitavastatin significantly reduced the frequency of periprocedural ischaemic complications with carotid artery stenting.</span></p></div> Piramal Imaging announces EU approval of NeuraCeq 2014-02-25T10:36:00Z 2014-02-25T10:36:00Z <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><span style="font-size: 11pt;"><strong>Piramal Imaging announced that NeuraCeq (florbetaben 18F) has received marketing authorisation from the European Commission. According to a company press release, NeuraCeq is a radiopharmaceutical indicated for positron emission tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer&rsquo;s disease and other causes of cognitive impairment.</strong></span></p> </div><div id="Text158" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">With this authorisation, NeuraCeq will soon be available to provide valuable information that may give physicians more confidence in their clinical assessment and help them provide more personalised patient management as a negative scan may rule out Alzheimer&rsquo;s disease as a cause of a patient&rsquo;s cognitive decline, the press release explains.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;With the prevalence of dementia predicted to grow dramatically in the coming decades, the global communities are mobilising to understand the pathology and progression of Alzheimer&rsquo;s disease and other forms of cognitive impairment,&rdquo; says Ludger Dinkelborg, director of the Board, Piramal Imaging. &ldquo;The approval of NeuraCeq in&nbsp;Europe&nbsp;will give healthcare providers a new tool to aid in the diagnostic assessment of Alzheimer&rsquo;s disease and other causes of cognitive impairment. Our goal from here is to get NeuraCeq into the hands of physicians later this year so they can help ensure timely and accurate assessments for patients.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The press release reports that data from the pivotal phase III autopsy study showed that PET imaging with NeuraCeq detects neuritic beta-amyloid in the brains of living subjects. The visual subject-level PET reading proposed for routine clinical practice compared to histopathology for the first 31 brains demonstrated 100% sensitivity and 86% specificity. In a post-hoc analysis in a larger population with 74 autopsied subjects, the sensitivity of the visual assessment was 98% and specificity was 89%.</span></p> <p><br /><span style="font-size: 10pt;">NeuraCeq will be available in select European countries in the second and third quarters of 2014.</span></p> <p><br /><span style="font-size: 10pt;">Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of NeuraCeq upon EU approval.</span> <strong><br /> <br /> </strong></p></div> New partnerships designed to advance Parkinson’s and dystonia care 2014-02-25T09:52:00Z 2014-02-25T09:52:00Z <div id="Introduction59" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Dystonia Europe and the European Parkinson&rsquo;s Disease Association announced in a press release that they are collaborating with Boston Scientific. The aim of these partnerships is to increase awareness, understanding of solutions and to take initiatives in the worldwide fight against Parkinson<strong>&rsquo;</strong>s disease and dystonia, two areas of high unmet need.</strong></span></p> </div><div id="Text159" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to the press release, Parkinson&rsquo;s disease affects approximately 1.2 million Europeans and seven to ten million people worldwide. Parkinson&rsquo;s is the second most common neurodegenerative disease after Alzheimer&rsquo;s and is forecast to double by 2030 as the population ages. In comparison, dystonia is the third most common movement disorder after Parkinson&rsquo;s disease and essential tremor. It affects more than 500,000 people across Europe, including children and adults.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Ongoing educational efforts are needed to extend awareness of dystonia in Europe. We aim to connect people and organisations for dystonia to improve the quality of life for people living with dystonia, to stimulate research for more effective treatments and ultimately, to find a cure. We are partnering with leading companies in this field in achieving this goal and we are delighted about this partnership with Boston Scientific,&rdquo; says Robert Scholten, president of Dystonia Europe.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;In Europe alone, the facts about Parkinson&rsquo;s disease are startling. The tremendous economic and social burden will increase even more in the years to come, so we need to take action now to limit the impact on people with Parkinson&rsquo;s, their families, carers and society as a whole. At the European Parkinson&rsquo;s Disease Association, we realised that we can only make a difference and be successful if we collaborate and share knowledge, so we are looking forward to working with Boston Scientific,&rdquo; says Knut-Johan Onarheim, president of European Parkinson&rsquo;s Disease Association.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The press release explains that under the terms of these equal partnerships, Dystonia Europe, the European Parkinson&rsquo;s Disease Association and Boston Scientific will work together on practical initiatives to improve Parkinson&rsquo;s and dystonia care in Europe. Boston Scientific is determined to innovate the treatment of both neurological disorders: Recently, the company developed a new deep brain stimulation system called Vercise. It is the first system designed to selectively stimulate targeted areas of the brain, which helps to customise therapy and manages symptoms of Parkinson&rsquo;s disease and dystonia syndromes.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Neurological diseases are among the greatest healthcare challenges we currently face.&nbsp;At Boston Scientific, we are committed to improving how the diseases are managed today and developing innovative medical technologies that have a real impact on people&rsquo;s lives. We are very pleased that we have the opportunity to work together with such strong and valued partners to advance dystonia and Parkinson&rsquo;s care in Europe,&rdquo; says Maulik Nanavaty, senior vice president and president of Neuromodulation at Boston Scientific.</span></p></div> Study shows that MS antibody may be detectable years before symptoms appear 2014-02-24T10:34:00Z 2014-02-24T10:34:00Z <div id="ImageMain60" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction60" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>An antibody found in the blood of people with multiple sclerosis may be present long before the onset of the disease and its symptoms, according to a recent study that will be presented at the American Academy of Neurology&rsquo;s 66th Annual Meeting in Philadelphia, USA, April 26 to May 3, 2014.</strong></span></p> </div><div id="Text160" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;If our results can be replicated in larger populations, our findings may help to detect MS earlier in a subgroup of patients,&rdquo; says study author Viola Biberacher, Technical University in Munich, Germany. &ldquo;Finding the disease before symptoms appear means we can better prepare to treat and possibly even prevent those symptoms. This finding also demonstrates that the antibody development to the KIR4.1 protein, a protein found in some people with multiple sclerosis, precedes the clinical onset of disease suggesting a role of the autoantibody in how the disease develops.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to a press release, for the study, 16 healthy blood donors who were later diagnosed with multiple sclerosis were compared to 16 healthy blood donors of the same age and sex who did not develop multiple sclerosis. Scientists looked for a specific antibody to KIR4.1. Samples were collected between two and nine months before the first symptoms of multiple sclerosis appeared.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Next, researchers looked at antibody levels in the blood at additional time points up to six years before and then after disease onset in those who had the KIR4.1 antibody in their blood.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />All of the healthy controls tested negative for the KIR4.1 antibody. Of those who later developed multiple sclerosis, seven people tested positive for the antibodies, two showed borderline activity and seven were negative.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />In the study, KIR4.1 antibodies were found in the people with pre-clinical multiple sclerosis several years before the first clinical attack. Concentrations of the antibody varied at different time points during pre-multiple sclerosis in individual people.&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The next step is to confirm these findings in larger groups and determine how many years before onset of disease the antibody response develops,&rdquo; says Biberacher.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The study was supported by the German Ministry for Education and Research and the German Competence Network for Multiple Sclerosis.</span></p></div> Stryker launches Trevo XP ProVue retrieval system 2014-02-21T17:35:00Z 2014-02-21T17:35:00Z <div id="ImageMain61" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction61" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Stryker has announced the global launch of the new Trevo XP ProVue Retriever. According to a company release, the Trevo XP ProVue Retriever expands the ProVue Retriever line with additional size and shape options for physicians. The Trevo ProVue Retrievers are the world&rsquo;s first stent retrievers with full-length visibility and are built on Trevo technology which has delivered strong clinical results and positive patient outcomes for acute ischaemic stroke patients.</strong></span></p> </div><div id="Text161" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The Trevo XP ProVue Retriever provides some of the best performance of the devices I&rsquo;ve used over the years to treat acute ischaemic stroke. The unique full-length visibility provides key information that we can use to successfully remove clots more efficiently. When combined with the Merci Balloon Guide Catheter, I feel I have a system that is easy to use and provides the potential for consistently good results,&rdquo; says Ronald Budzik, Interventional Neuroradiology/Neurointerventional Surgery; chair, Neuroscience Clinical Operations Council; co-director, Riverside Comprehensive Stroke Centre, Ohio Health, Riverside Methodist Hospital, Columbus, Ohio, USA.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">Joey D English, director of Neurointerventional Services, California Pacific Medical Centre, San Francisco, California, USA, adds, &ldquo;The new Trevo XP ProVue Retriever is smooth and easy to use. It has excellent deliverability and the visibility it provides allows me to confidently deploy the device in the best position to capture and remove the clot. I can visualise the clot and strut interaction during the case and this provides valuable feedback for clot removal.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">The Trevo XP ProVue Retriever is supported by robust clinical evidence from the <a href=";rank=1" target="_blank"><strong>TREVO</strong></a> and <a href=";rank=2" target="_blank"><strong>TREVO 2</strong></a> clinical trials, which demonstrated high revascularisation and a high rate of good clinical outcomes compared to the earlier generation Merci Retriever. Additionally, physicians participating in the <a href=";rank=3" target="_blank"><strong>Trevo Retriever Registry</strong></a>, a multicentre, international data collection study, will be collecting real world data on the Trevo XP ProVue Retriever. The device has been granted 510(k) market clearance by the U.S. Food and Drug Administration and is also available in international markets where it has been cleared for sale.</span></p></div> Vitae earns US$14 million milestone payment from Boehringer Ingelheim in Alzheimer&apos;s collaboration 2014-02-21T16:29:00Z 2014-02-21T16:29:00Z <div id="Introduction62" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Vitae Pharmaceuticals announced that it has earned a US$14 million milestone payment from Boehringer Ingelheim for that company&rsquo;s initiation of a Phase I clinical trial in the Vitae&rsquo;s beta-secretase (BACE) inhibitor programme for Alzheimer&rsquo;s disease.</strong></span></p> </div><div id="Text162" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;This achievement offers new promise for those suffering from Alzheimer&rsquo;s disease - patients who are urgently in need of new treatment options,&rdquo; says Jeff Hatfield, chief executive officer of Vitae.&nbsp; &ldquo;Our strong working relationship with Boehringer has produced great science, and the opportunity to deliver a best-in-class compound to patients.&rdquo;&nbsp; </span><br /> <br /><span style="font-size: 10pt;"> According to a press release, the collaboration aims to discover and develop beta-secretase inhibitors to slow or halt the formation of amyloid-beta plaques that accumulate in the brains of Alzheimer&rsquo;s patients and are widely associated with the disease.&nbsp; Within 18 months of Vitae initiating full-scale research efforts on BACE, Vitae partnered with Boehringer Ingelheim, generating US$42 million in upfront and research funding and the opportunity to earn more than US$200 million in pre-commercial payments in addition to sales milestones and royalties.</span></p></div> Fluoride newly identified as dangerous to brains 2014-02-21T16:03:00Z 2014-02-21T16:03:00Z <div id="ImageMain63" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction63" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Fluoride has joined lead, arsenic, methylmercury, toluene, tetrachloroethylene, and other chemicals known to cause harm to brains, reports the Fluoride Action Network.</strong></span></p> </div><div id="Text163" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Fluoride is newly classified as a developmental neurotoxin by medical authorities in the March 2014 journal Lancet Neurology.&nbsp; The authors are Philippe Grandjean of the Harvard School of Public Health and Philip Landrigan of the Icahn School of Medicine, according to a press release.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The authors write &ldquo;A meta-analysis of 27 cross-sectional studies of children exposed to fluoride in drinking water, mainly from China, suggests an average IQ decrement of about seven points in children exposed to raised fluoride concentrations.&rdquo;&nbsp; The majority of these 27 studies had water fluoride levels which the US Environmental Protection Agency currently allows in the US &ndash; less than four milligrams per litre.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />According to the press release, developmental neurotoxins are capable of causing widespread brain disorders such as autism, attention deficit hyperactivity disorder, learning disabilities, and other cognitive impairments.&nbsp; The harm is often untreatable and permanent.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Grandjean and Landrigan write, &ldquo;Our very great concern is that children worldwide are being exposed to unrecognised toxic chemicals that are silently eroding intelligence, disrupting behaviours, truncating future achievements, and damaging societies, perhaps most seriously in developing countries.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The authors say it&rsquo;s crucial to control the use of all harmful chemicals to protect children&rsquo;s brain development. They propose mandatory testing of these chemicals and the urgent formation of a new international clearinghouse to evaluate them for potential neurotoxicity.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;Fluoride seems to fit in with lead, mercury, and other poisons that cause chemical brain drain,&rdquo; Grandjean says. &ldquo;The effect of each toxicant may seem small, but the combined damage on a population scale can be serious, especially because the brain power of the next generation is crucial to all of us.&rdquo;</span></p> </div> Takeda joins the Global CEO Initiative on Alzheimer’s disease 2014-02-21T15:59:00Z 2014-02-21T15:59:00Z <div id="Introduction64" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Global CEO Initiative (CEOi) on Alzheimer&rsquo;s Disease announced that Takeda Pharmaceutical Company will join the CEOi as part of its effort to spur innovations in research and accelerate a means of prevention for Alzheimer&rsquo;s and dementia, building momentum behind the G8&rsquo;s commitment to stop the disease by 2025.</strong></span></p> </div><div id="Text164" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The CEOi has a unique role in unifying the Alzheimer&rsquo;s movement,&rdquo; says Tetsuyuki Maruyama, corporate officer, general manager of Pharmaceutical Research Division at Takeda. &ldquo;We are excited to join the CEOi and believe that, through the its powerful collaborative model, we can play an important role in developing the new innovations in Alzheimer&rsquo;s drug development that are necessary to meet the goal of stopping the disease by 2025.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Through its diverse group of partner corporations, including Takeda, the CEOi is seeking to work closely with governments and global institutions to advance meaningful reforms to the Alzheimer&rsquo;s drug marketplace, a press release reports.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;We are thrilled that Takeda is joining us and our partners,&rdquo; says George Vradenburg, convener of the CEOi. &ldquo;Takeda will play a key role in helping the CEOi reshape the Alzheimer&rsquo;s discovery and drug development marketplace in order to speed the development of a disease-modifying treatment or cure for Alzheimer&rsquo;s.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Takeda, located in Osaka, Japan, will join AC Immune, Bank of America, Banner Health, GE, Home Instead Senior Care, Janssen, Eli Lilly, Merck, Nestle Health Science, Pfizer and Sanofi in the CEOi.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The Global CEO Initiative (CEOi) on Alzheimer&rsquo;s Disease is an organisation of private-sector leaders who have joined together with government to provide business leadership in the fight against Alzheimer&rsquo;s. The CEO Initiative seeks to partner with public leaders to transform the disease from a social, health, and economic crisis into an opportunity for healthy aging and innovation in research and care.</span></p></div> STC Life successfully treats patients with Parkinson&apos;s disease at stem cell research and treatment centre 2014-02-20T11:50:00Z 2014-02-20T11:50:00Z <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>The stem cell research institute&nbsp;of STC Life and 97.7 B&amp;H Clinic successfully completed mesenchymal stem cell therapy for patients with Parkinson&rsquo;s disease.</strong></span></p> </div><div id="Text165" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, 97.7 B&amp;H Clinic administered stem cell into vein of the patients with Parkinson&rsquo;s disease three times every two weeks. Mesenchymal stem cell, one of the adult stem cells, is used a lot for neogenesis, and the stem cell research institute of STC Life used stem cells separated from umbilical cord of foetus.</span></p> <p><br /><span style="font-size: 10pt;">The patients who got stem cell therapy showed remarkable reduction of the symptoms, such as lalopathy and paralysis of arms and legs, and also showed satisfactory progress to be able to do light exercise. Furthermore, their linguistic ability, visual function and memory have increased and have not shown remarkable deterioration in cognitive function, the press release reports.</span></p></div> Michael J Fox Foundation to fund the use of GlycanMap technology in Parkinson’s research 2014-02-20T11:33:00Z 2014-02-20T11:33:00Z <div id="Introduction66" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Ezose Sciences has announced that it has received a grant from the Michael J Fox Foundation for Parkinson&rsquo;s Research to apply Ezose&rsquo;s GlycanMap technology to investigating the role of the sugars known as glycans in Parkinson&rsquo;s disease.</strong></span></p> </div><div id="Text166" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Ezose&rsquo;s GlycanMap technology enables automated analysis of glycans, which attach to proteins in the body and affect their biochemical function. The speed, scope, and quantitative power of this technology hold the potential for discovering novel glycan changes associated with altered protein function during the onset and progression of wide-ranging diseases, including Parkinson&rsquo;s disease and other neurological disorders. Glycans could serve as novel biomarkers for guiding clinical management and drug development and provide insight into disease mechanism and novel drug targets, a press release reports.</span></p> <p><br /><span style="font-size: 10pt;">The research funded by the foundation will be performed in Ezose&rsquo;s laboratories, where the GlycanMap assay will be used to compare glycan profiles in brain-stem tissue from rat models of Parkinson&rsquo;s disease and control rats over time and with respect to development of symptoms.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The Michael J Fox Foundation has brought a tireless sense of urgency to advancing research into Parkinson&rsquo;s disease,&rdquo; says Ryuichi Kiyama, chairman and chief executive officer of Ezose. &ldquo;We look forward to bringing that spirit as well as our technical capabilities to this novel research project.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">Mark Frasier, vice president of Research Programmes at The Michael J Fox Foundation, comments: &ldquo;Two important steps toward the development of a disease-modifying therapy for Parkinson&rsquo;s are greater understanding of the underlying pathology of the disease and validation of a reliable biomarker. Ezose&rsquo;s glycan analysis offers a new approach to serve those goals and bring us closer to a Parkinson&rsquo;s cure.&rdquo;</span></p></div> IMRIS launches world&apos;s first MR-safe and CT-compatible neurosurgical horseshoe headrest 2014-02-19T17:27:00Z 2014-02-19T17:27:00Z <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>IMRIS has announced the launch of the world&rsquo;s first MR-safe and CT-compatible horseshoe headrest on the market for the positioning of patients ranging from neonatal to adult during neurosurgical procedures requiring intraoperative imaging in the VISIUS surgical theatre.</strong></span></p> </div><div id="Text167" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The horseshoe headrest provides non-pinned head support in prone, lateral, and supine positions during head, neck and cervical spine surgeries where use of a head fixation device - a clamp-like device - is not desirable because the skull is too fragile for pinning.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;The IMRIS horseshoe headrest expands the use of intraoperative imaging to patients who cannot be positioned for surgery with a head fixation device, such as neonatal and young paediatric patients. This headrest may also be useful for other applications not requiring rigid fixation, such as those that access the skull through the nose,&rdquo; says James Baumgartner, surgical director of the Comprehensive Paediatric Epilepsy Centre at Florida Hospital. &ldquo;This will enhance an already sophisticated technology platform that includes intraoperative MR and the comprehensive team approach we have for paediatric tumour and epilepsy care.&rdquo;</span></p></div> Clinical study focused on innovations in Parkinson’s disease biomarker discovery announced 2014-02-19T15:49:00Z 2014-02-19T15:49:00Z <div id="ImageMain68" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction68" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Berg and the Parkinson&rsquo;s Institute and Clinical Centre has announced the next phase in their ongoing partnership, focused on identifying potential biomarkers that may lead to breakthroughs in the research, diagnosis, and treatment of Parkinson&rsquo;s disease.&nbsp;</strong></span></p> </div><div id="Text168" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Using Berg&rsquo;s Interrogative Biology platform to analyse multi-omic tissue samples supplied by the Parkinson&rsquo;s Institute, this collaboration will identify the differences between healthy and diseased tissues in an effort to unravel the mysteries of Parkinson&rsquo;s disease. Berg and the Parkinson&rsquo;s Institute together are the first teams to approach biomarker discovery by looking at proteomics, metabolomics, and lipidomics, in addition to clinical data, simultaneously in human patients and controls from the same cohort, a press release reports. &nbsp;&nbsp;&nbsp;</span></p> <p><br /><span style="font-size: 10pt;">According to the press release, the new clinical study launched at the Parkinson&rsquo;s Institute and Clinical Centre will collect urine, blood, and other relevant tissue samples from people living with Parkinson&rsquo;s disease. These materials will be used to validate biomarker candidates identified previously from the collaboration. Most importantly, this will represent a first in merging patients&rsquo; molecular and clinical information to develop profiles that will drive the development of biomarkers.</span></p> <p><br /><span style="font-size: 10pt;">The expectation for this partnership is that it will help lead to a greater understanding of Parkinson&rsquo;s disease and the development of new tools that can change its course.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;Through our collaboration with Berg, we hope to identify predictors for the disease and potential new drug targets. Armed with this information, we will be able to better diagnose and develop therapies that can treat and perhaps even halt the neurological damage caused by Parkinson&rsquo;s,&rdquo; says&nbsp;Birgitt Schuele, director of Gene Discovery and Stem Cell Modelling at the Parkinson&rsquo;s Institute. &ldquo;This collaboration is very exciting. Our discoveries have the potential to change the way we think about and approach Parkinson&rsquo;s disease.&rdquo;</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div> Reverse Medical announces CE mark of UNO neurovascular embolisation system 2014-02-19T09:55:00Z 2014-02-19T09:55:00Z <div id="Introduction69" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Reverse Medical Corporation has announced the initial clinical use of their UNO neurovascular embolisation system for intracranial use. The device has been granted European Union CE mark approval to obstruct blood flow in the neurovasculature.</strong></span></p> </div><div id="Text169" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Marco Leonardi at Universit&agrave; di Bologna, Italy performed the initial UNO system clinical case. Leonardi comments, &ldquo;The UNO represents a unique device, specifically designed for rapid vessel sacrifice, reducing the time otherwise necessary for multiple coil deployments. I can see the UNO becoming a useful tool in my practice. Microcatheter deliverability is excellent within tortuous anatomy, and re-sheathability offers me confidence of placement accuracy.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to a press release, Reverse Medical will continue to confirm superior clinical device performance from the UNO System and begin commercialisation in Europe this year through a network of expert regional distributors.</span></p></div> FDA classifies worldwide voluntary correction notice on Trufill at Class I Recall 2014-02-18T13:12:00Z 2014-02-18T13:12:00Z <div id="Introduction70" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Codman Neuro announced that the US Food and Drug Administration (FDA) has classified the recently initiated medical device correction notice related to the Trufill n-BCA liquid embolic system as a Class I recall.</strong></span></p> </div><div id="Text170" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, Trufill n-BCA is indicated for embolisation of cerebral arteriovenous malformations (AVMs) when presurgical devascularisation is desired. The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolisation or reflux into arteries and pulmonary vessels. This could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.</span></p> <p><br /><span style="font-size: 10pt;">In October 2013, Codman Neuro identified an incorrect statement in the product&rsquo;s Instructions For Use (IFU) that described suggested mixing ratios for use in certain treatment conditions, informed the US Food and Drug Administration and other regulatory authorities, and issued a corresponding correction notice to inform customers in the US, Costa Rica, Puerto Rico and Russia. The error was identified through routine internal procedures. The product is not being removed from the market, the press release reports.</span></p> <p><br /><span style="font-size: 10pt;">The company is informing physicians of this incorrect statement and updating the product&rsquo;s Instructions For Use. The product&rsquo;s Instructions For Use incorrectly noted: &ldquo;A 2:1 (67% Ethiodized Oil / 33% nBCA) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injections within 1/2 second.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The correct information should have stated: &ldquo;A 2:1 (67% Ethiodized Oil / 33% nBCA) for Intranidal injections without AV fistulae or high flow rates in order to more deeply penetrate the nidus.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">The press release adds, no corresponding patient deaths or permanent patient injuries have been reported to date. When the product is mixed correctly, it is expected to perform as intended. Thorough product training is required before purchasing the Trufill nBCA. The company has verified that all related physician training materials and promotional documents contain correct information.</span></p></div> MIT professor joins Constant Therapy’s Scientific Advisory Board 2014-02-18T12:52:00Z 2014-02-18T12:52:00Z <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>Constant Therapy, a developer of a cloud-based iPad solution enabling people with cognitive, language, communication and learning disorders to access science-based brain therapies, has announced that John Gabrieli, Massachusetts Institute of Technology (MIT) Brain and Cognitive Sciences professor, has joined the company&rsquo;s Scientific Advisory Board.</strong></span></p> </div><div id="Text171" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">A press release reports that Gabrieli is the director of the Athinoula A Martinos Imaging Centre at the McGovern Institute for Brain Research at MIT. He is an investigator at the Institute, with faculty appointments in the Department of Brain and Cognitive Sciences and the Institute for Medical Engineering &amp; Science, where he has the Grover Hermann Professorship. Prior to joining MIT, he spent 14 years at Stanford University in the Department of Psychology and Neurosciences Programme. Since 1990, he has served as visiting professor, Department of Neurological Sciences, Rush-Presbyterian-St. Luke&rsquo;s Hospital and Rush Medical College.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;I am excited to be a part of&nbsp;Constant Therapy&nbsp;as it is transforming the delivery of brain rehabilitation and will help brain injury survivors to recover in ways never before possible. This is important work; the analytics provided by&nbsp;Constant Therapy&nbsp;is a key enabler in understanding how the brain responds to different courses of therapy and will be invaluable in allowing us to optimise therapies unique to individual patients,&rdquo; Gabrieli says.</span></p></div> New stroke therapy produced significant gains in motor function post-stroke 2014-02-18T12:22:00Z 2014-02-18T12:22:00Z <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>New stroke therapy, using a combination of non-invasive navigated transcranial stimulation along with occupational therapy, has been found to produce significant gains in motor function post-stroke, with an average of 50% of stroke survivors recovering full use of their arm.</strong> </span></p> </div><div id="Text172" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The study, presented by Richard L Harvey and his team, Rehabilitation Institute of Chicago, at the American Heart Association and the American Stroke Association&rsquo;s International Stroke Conference, yielded results from the active group of improved function by 13+ points in Upper Extremity Fugl-Meyer (UEFM) score.</span><br /> <br /><span style="font-size: 10pt;"> According to a press release, treatment consisted of 20 minutes of pre-functional occupational therapy, 17 minutes of navigated transcranial stimulation, followed by 60 minutes of upper limb task-oriented occupational therapy. Patients received treatment during three visits per week, for six weeks, as the standard of care in the US. They then returned for follow-up visits at one week, one month, and six months. The study found that Nexstim&rsquo;s non-invasive Navigated Brain Stimulation system used as an adjunct to therapy promoted lasting improvements in patients&rsquo; motor function compared to the sham group. </span><br /> <br /><span style="font-size: 10pt;"> Nexstim&rsquo;s Navigated Brain Stimulation system uses stereotactic, MRI-guided transcranial magnetic stimulation to non-invasively modulate precise areas of the motor cortex. The system&rsquo;s e-field-based targeting tool allows the therapist to accurately locate the patient&rsquo;s exact stimulation location using technology similar to navigating the globe with a global positioning system (GPS). The navigated transcranial magnetic stimulation was used to stimulate the patient&rsquo;s non-injured hemisphere at low frequency. The navigated transcranial magnetic stimulation affects the excitability of the brain, down-regulating the healthy side of the brain. Adding navigation to transcranial magnetic stimulation is the key to finding the exact location and orientation of the e-field of the motor area that should be inhibited by stimulation. Nexstim&rsquo;s targeted stimulation has been proven to correlate with Direct Cortical Stimulation in the operating room, the press release reports.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;What we found is that there are areas of the brain, usually where the lesion is, that are less active than they used to be, and that there are actually areas on the brain on the opposite hemisphere, the healthy side of the brain, that are more active than they used to be,&rdquo; says&nbsp;Lynn Rogers, director, Neuralplasticity Laboratory, Rehabilitation Institute of Chicago.</span></p></div> FDA clears next generation VISIUS surgical theatre 2014-02-18T10:55:00Z 2014-02-18T10:55:00Z <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>IMRIS has announced US Food and Drug Administration (FDA) clearance of the newest generation VISIUS surgical theatre which integrates Siemens&rsquo; latest high-field magnetic resonance (MR) scanners.</strong></span></p> </div><div id="Text173" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, the new core imaging technology based on Siemens Aera 1.5T (tesla) and Skyra 3.0T technology helps IMRIS deliver better image quality with higher signal-to-noise ratio, faster 3D image acquisition, and improved ease-of-use and workflow during neurosurgical procedures using intraoperative magnetic resonance imaging (iMRI).</span></p> <p><br /><span style="font-size: 10pt;">The addition of these MR systems expands the industry-leading 1.5T and 3.0T MRI choices hospitals have when considering the unique, ceiling-mounted IMRIS solution for intraoperative imaging which brings the MRI to the patient during the procedure.</span></p> <p><br /><span style="font-size: 10pt;">The first installation of this new generation VISIUS surgical theatre will be a four-room hybrid operating room suite, known as the Centre for Surgical Innovation at Dartmouth-Hitchcock Medical Centre in Lebanon, New Hampshire, USA. &ldquo;Surgeons are too often limited by what they cannot see - anatomy that is difficult to reach or diseases that are not visible to the naked eye,&rdquo; says Sohail Mirza, medical director of the Centre for Surgical Innovation and chair of orthopaedics at Dartmouth-Hitchcock. &ldquo;The advanced integration of state-of-the-art imaging tools in the Centre for Surgical Innovation will allow surgeons and engineers to innovate like never before, rapidly developing, testing, and validating new surgical tools and techniques, with the goal of achieving better, safer, and, in some cases, less-costly care for patients everywhere.&rdquo; </span></p> <p><br /><span style="font-size: 10pt;">The Dartmouth-Hitchcock installation will also include a VISIUS intraoperative computerised tomography (iCT), which utilises the technology of the 64-slice Siemens SOMATOM Definition AS scanner, making it the only operating suite in the world with both VISIUS iMRI and iCT modalities able to serve multiple operating rooms without moving the patient, the press release reports.</span></p></div> New study results demonstrate value of Cerox cerebral oxidation monitor 2014-02-18T10:14:00Z 2014-02-18T10:14:00Z <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>Ornim Medical has announced that new study results demonstrate the feasibility of the Cerox cerebral oxidation monitor for measuring regional cerebral tissue oxygenation in patients with severe traumatic brain injury.</strong></span></p> </div><div id="Text174" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, the Cerox monitor employs Ornim Medical&rsquo;s patented UTLight technology, which utilises weak acoustic beams to identify light emerging from deep tissue layers. UTLight harnesses the ability of near-infrared light to measure regional oxygen saturation in combination with ultrasound that can achieve localisation via the acousto-optic effect. The Cerox monitor is the only US Food and Drug Administration-cleared device enabling continuous, non-invasive measurement of blood flow and oxygen saturation in real time.</span></p> <p><br /><span style="font-size: 10pt;"> &ldquo;Cerox represents a major advance in the care of patients with traumatic brain injury,&rdquo; says Daryl R Gress, associate professor of Neurology and Neurosurgery, and director of Neurocritical Care, University of Virginia. &nbsp;&ldquo;Measuring both blood flow and oxygen saturation in real time allows neurointensivists and neurosurgeons to act quickly and decisively to optimise haemodynamics, blood pressure and intracranial pressure management strategies in the critical care setting.&rdquo;&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />Eighteen patients with severe traumatic brain injury admitted to the intensive care unit requiring intracranial pressure monitoring and advanced neuromonitoring were included in the study.&nbsp;The authors found a strong correlation (r = 0.60, p &lt;0.001) between the jugular bulb venous saturation from the venous blood gas and the Cerox measure of regional cerebral tissue saturation on the side ipsilateral to the catheter. A multivariate analysis revealed that among the physiological parameters of mean arterial blood pressure, intracranial pressure, brain tissue oxygen tension, and Cerox measurements on the ipsilateral and contralateral sides, only ipsilateral Cerox measurements were significantly correlated to jugular bulb venous saturation (p &lt; 0.001).&nbsp; </span><br /> <br /><span style="font-size: 10pt;"> The authors concluded that the correlation between the Cerox measurements and the jugular bulb venous measurements of oxygen saturation indicate that the CerOx may be able to provide an estimation of cerebral oxygenation status in a noninvasive manner, the press release reports.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />The <a href="" target="_blank"><strong>study is currently available online</strong></a> in the <em>Journal of Neurosurgery</em>, the official journal of the American Association of Neurological Surgeons.</span></p></div> InspireMD reports successful implantation of the new CGuard carotid embolic system with MicroNet technology 2014-02-17T10:08:00Z 2014-02-17T10:08:00Z <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>InspireMD has announced that its new CGuard carotid embolic protection system has been successfully implanted in recent procedures, including a patient treated during the 17th Annual Symposium on Interventional Cardiology &amp; Angiology held in Hamburg, Germany on February 1, 2014.</strong></span></p> </div><div id="Text175" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, the proprietary CGuard carotid embolic protection system uses the same MicroNet technology featured on its MGuard and MGuard Prime coronary systems. The MicroNet technology is a single fibre knitted mesh wrapped on an open cell stent design in order to trap the debris that can travel downstream after a patient is treated with traditional stenting methods. This protects patients from plaque debris and blood clots breaking off and traveling distally in the arteries which can lead to life threatening strokes. The size, or aperture, of the MicroNet &lsquo;pore&rsquo; is only 150-180 microns in order to maximize protection against plaque and thrombus.</span></p> <p><br /><span style="font-size: 10pt;">The CGuard is CE marked and is currently being evaluated clinically in Europe. The initial clinical placements are expected to provide physician feedback and information for the company to better understand the complexities and challenges of this disease state within the patient population and help define further clinical activities for CGuard, the press release reports.</span></p> <p><br /><span style="font-size: 10pt;">&ldquo;As a clinician who has successfully implanted the CGuard carotid embolic protection in multiple patients, I have experienced first-hand the life-saving applications it can have,&rdquo; says Joachim Schofer, Hamburg University Cardiovascular Centre, Hamburg, Germany. &ldquo;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 for my carotid patients.&rdquo;</span></p></div> Intracranial carotid artery atherosclerosis associated with increased stroke risk 2014-02-17T10:02:00Z 2014-02-17T10:02:00Z <div id="Introduction76" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>A build-up of plaque in the carotid artery above the neck was associated with an increased risk of stroke for older white patients in a study by Daniel Bos, Erasmus Medical Centre, Rotterdam, the Netherlands, and colleagues.</strong></span></p> </div><div id="Text176" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, the authors studied 2,323 white patients (average age, 69.5 years) who underwent computed tomography scanning to quantify the volume of intracranial carotid artery calcification, a marker of intracranial atherosclerosis, between 2003 and 2006. The patients were monitored for strokes until 2012.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />During follow-up, 91 patients had a stroke: 74 were ischemic, 10 were due to bleeding and seven were unspecified. Larger intracranial carotid artery calcification volume was associated with higher stroke risk, independent of other stroke risk factors, such as carotid plaque score and calcification in other blood vessels.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p> <p><span style="font-size: 10pt;"><br />&ldquo;The findings of our study suggest that intracranial atherosclerosis is a major risk factor for stroke in the general white population,&rdquo; the authors conclude.</span></p> <p><span style="font-size: 10pt;">&nbsp;</span></p></div> Brain Research Foundation announces 2014 Scientific Innovations Awards 2014-02-11T12:47:00Z 2014-02-11T12:47:00Z <div id="Introduction77" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>The Brain Research Foundation has announced three recipients of its 2014 Scientific Innovations Awards programme for researchers investigating novel pathways to detect, treat and better comprehend serious neural diseases such as&nbsp;Parkinson&rsquo;s&nbsp;and schizophrenia.</strong></span></p> </div><div id="Text177" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;The innovation that these researchers bring to addressing the scientific understanding and potential treatment of devastating diseases is inspiring,&rdquo; says&nbsp;Terre A Constantine, executive director of the Brain Research Foundation. &ldquo;If this research proves these approaches successful, many areas of neuroscience will benefit.&rdquo;</span></p> <p><br /><span style="font-size: 10pt;">According to a press release, the Scientific Innovations Awards support innovative discovery in both basic and clinical neuroscience. This funding mechanism is designed to support creative, cutting edge research in well-established research laboratories, under the direction of established investigators.</span></p> <p><br /><span style="font-size: 10pt;">Descriptions of the work funded by the 2014 Scientific Innovations Awards follow:</span></p> <p><br /><span style="font-size: 10pt;">A &ldquo;burst&rdquo; is a brief period of high-frequency activity within neurons that can have a powerful impact on brain circuits. Symptoms in human diseases like Parkinson&rsquo;s and&nbsp;epilepsy&nbsp;are thought to be influenced by &ldquo;overly-exuberant&rdquo; bursting. With his 2014 Scientific Innovations Award,&nbsp;Christopher I Moore, Department of Neuroscience at&nbsp;Brown University, will conduct research to determine if biological strategies can be effective at modulating thalamic bursts. Data gathered may indicate potential for entire new treatment strategies, reducing or eliminating the need </span><span style="font-size: 10pt;">for intrusive and painful electrode implants.</span></p> <p><br /><span style="font-size: 10pt;">Hurler syndrome&nbsp;is a genetic disease that manifests itself after birth through developmental delay, dwarfism, mental retardation and frequently, death prior to ten years of age. With a 2014 Scientific Innovations Award,&nbsp;W Mark Saltzman, Department of Biomedical Engineering at&nbsp;Yale University, will attempt to correct the gene disorder in Hurler syndrome in mice by &ldquo;editing&rdquo; genes in utero using nanotechnology. The potentially transformative approach, if successful, can be applied to any single gene defect &ndash; such as Huntington&rsquo;s disease and Fragile-X syndrome.</span></p> <p><br /><span style="font-size: 10pt;">Disruptions in neural circuitry cause many diseases such&nbsp;autism&nbsp;and schizophrenia. However, scientists&rsquo; ability to study brain wiring has been greatly limited. Using a 2014 Scientific Innovations Award,&nbsp;Anthony Zador, Department of Neuroscience, Cold Spring Harbor Laboratory, will test an innovative alternative to mapping neural connectivity. Rather than &ldquo;take&rdquo; a picture of brain wiring and connectivity through microscopy, Zador will &ldquo;build&rdquo; a picture or model through a unique DNA sequencing technique. The approach will be used to assess the brain wiring in a mouse model of autism. If successful, this technique can potentially be used to analyse neural circuitry disruptions in a great number of neuropsychiatric disorders.</span></p> <p><br /><span style="font-size: 10pt;">The Scientific Innovations Award grants are specifically for projects that may be too innovative and speculative for traditional funding sources but still have a high likelihood of producing important findings in a very short timeframe. It is expected that investigations supported by these grants will yield high impact data and result in additional major grant funding and significant publications in key journals, the press release reports.</span></p></div> MRI increases the incidence of extra-axial intracranial tumour diagnosis 2014-02-10T12:15:00Z 2014-02-10T12:15:00Z <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><strong><span style="font-size: 11pt;">A Norwegian study has found that cerebral, regional magnetic resonance imaging (MRI) can lead to an increase in incidence rates of intracranial tumour diagnosis.</span></strong></p> </div><div id="Text178" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The authors Ole Solheim, department of Neurosurgery, St Olav&rsquo;s University Hospital, Trondheim, Norway and others say that a subgroup analysis revealed that there was correlation between increased diagnosis of benign extra-axial tumours but not intra-axial tumours. The results were published in <strong><a href="" target="_blank"><em>Journal of Neurosurgery</em></a></strong>.</span><br /><br /><span style="font-size: 10pt;">&ldquo;It is assumed that the observed increase in brain tumour incidence may at least partially be explained by increased use of MRI,&rdquo; Solheim <em>et al</em> say. They therefore aimed to examine the regional frequencies of cerebral MRI use correlate to regional incidence rates of intracranial tumours and survival of the patients with these tumours.</span><br /><br /><span style="font-size: 10pt;">From data correlated from Norwegian population registries (January 2002 to December 2007), the authors investigated annual regional rates of cerebral MRI scans regional age- and sex-adjusted brain tumours.</span><br /><br /><span style="font-size: 10pt;">The annual number of cerebral MRI scans increased substantially, according to the results, during the study period, with large regional differences. The authors also report a &ldquo;steady annual increase in diagnosed intracranial tumours.&rdquo;</span><br /><br /><span style="font-size: 10pt;">They ascertained, from 50,000 annual scans and 6,363 primary tumours found during the study period, that were was a &ldquo;positive correlation between the annual number of cerebral scans per 100,000 capita and age- and sex-adjusted incidence rates of intracranial tumours varies in Norwegian counties&rdquo; (Spearman&rsquo;s rank correlation coefficient=0.35, p&lt;0.001).</span><br /><br /><span style="font-size: 10pt;">An increase in one MRI per 100,000 capita per year results in a 0.004 (95%; confidence interval 0.002&ndash;0.006) increase in diagnosed intracranial tumours per 100,000 capita per year (p&lt;0.001), according to the study.</span><br /><br /><span style="font-size: 10pt;">A subgroup analysis also demonstrated that there was a correlation between MRI and the increased incidence rate of extra-axial tumours (p=0.04, Spearman&rsquo;s rank correlation coefficient =0.28), but not intra-axial (p=0.394). The association between MRI scans per capita and overall survival was associated with the number of cerebral MRI scans per capita in the county of residence at the time of diagnosis (log-rank test p=0.029). However, after adjusting for year of diagnosis and geographical health region of the Norwegian neurological centres, this was found not to be statistically significant (p=0.076).</span><br /><br /><span style="font-size: 10pt;">Concluding, Solheim and colleagues say: &ldquo;Largely due to the incidental discovery of benign extra-axial tumours, regional differences in the use of cerebral MRI in outpatients affect observed incidence rates of intracranial tumours.&rdquo;</span></p></div> BrainStorm signs definitive agreement with Mayo Clinic for ALS clinical trial 2014-02-05T15:01:00Z 2014-02-05T15:01:00Z <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><strong><span style="font-size: 11pt;">BrainStorm Cell Therapeutics has announced that it has signed a definitive agreement with the Mayo Clinic in Minnesota, USA to conduct its phase II clinical trial of NurOwn in amyotrophic lateral sclerosis (ALS), pending FDA approval. In addition, Mayo&rsquo;s Human Cell Therapy Laboratory will manufacture the NurOwn cells for their clinical trial participants.</span></strong></p> </div><div id="Text179" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;BrainStorm&rsquo;s mesenchymal stem cell-based approach is very compatible with some of the research conducted in our centre,&rdquo; comments Anthony Windebank, professor of neurology and principal investigator of the study. </span><span style="font-size: 10pt;"><span style="font-size: 10pt;">&ldquo;</span>This trial is a logical next step in developing novel treatments for ALS which is a terrible disease with no effective treatment for our patients and their families&rdquo;, he adds.</span></p></div> US dementia experts to share best practices in phase III clinical research study in Alzheimer&apos;s disease in Russia 2014-02-05T14:44:00Z 2014-02-05T14:44:00Z <div id="Introduction80" style="clear:both;"> <p><strong><span style="font-size: 11pt;">Clinical research doctors of the TauRx Therapeutics&rsquo; global phase III clinical trial for mild-to-moderate Alzheimer&rsquo;s disease will welcome a US doctor-and-nurse team from the&nbsp;Neurological Associates of Albany&nbsp;clinic to share their experience and expertise in conducting this study with their Russian counterparts in preparation for the study&rsquo;s launch in&nbsp;Russia.</span></strong></p> </div><div id="Text180" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;We are honoured to have this unique opportunity to share our experience with this clinical research study with our counterparts in&nbsp;Russia,&rdquo; sayd Richard Holub, a neurologist and a leading principal investigator for the TauRx clinical research study. &ldquo;As a global clinical research community, we are all striving for the same goal &ndash; to find a treatment that slows or halts the progression of Alzheimer&rsquo;s disease &ndash; and this collaboration reflects that shared objective. By sharing our knowledge with the Russian clinical team we hope to impart our experience which they can then integrate into their own centres as the clinical research study kicks off there.&rdquo;</span></p> <p><span style="font-size: 10pt;"><br />Holub and&nbsp;Sue Brignull, a nurse specialist at the clinic, have screened and enrolled more than 30 mild-to-moderate Alzheimer&rsquo;s disease patients into TauRx Therapeutics&rsquo; phase III clinical trials since the studies launched in the USA in late 2012. Their background and commitment to the clinical studies prompted TauRx Therapeutics to invite them to speak to principal investigators in&nbsp;Russia&nbsp;about the practical &ldquo;nuts &amp; bolts&rdquo; of conducting this trial, identifying eligible patients and supporting study participants in their journey through the clinical research process. Holub has been asked to provide insights and advice on diverse issues from the screening process through study completion.</span></p> <p><span style="font-size: 10pt;"><br />The phase III trial is one of two studies evaluating the use of LMTX, a tau aggregation inhibitor that targets &ldquo;tau tangles&rdquo; in the brain. If the findings of the large scale global studies are consistent with the earlier phase 2 study, they could provide the first definitive data on a tau-based treatment that dissolves the tangles and slows or halts Alzheimer&rsquo;s disease. The studies culminate three decades of research by Professor&nbsp;Claude Wischik&nbsp;and colleagues at TauRx Therapeutics. In total, the two large, phase 3 studies will involve over 1,500 patients with mild to moderate Alzheimer&rsquo;s in more than 20 countries.</span></p></div> Tecfidera approved in the European Union as a first-line oral treatment for multiple sclerosis 2014-02-05T13:15:00Z 2014-02-05T13:15:00Z <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><strong><span style="font-size: 11pt;">Tecfidera (dimethyl fumarate) has been approved by the European Commission as a first-line oral treatment for people with relapsing-remitting multiple sclerosis.</span></strong></p> </div><div id="Text181" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release issued by Tecfidera manufacturer, Biogen Idec, the European Commission approval is based on a robust clinical development programme that included two global phase 3 clinical trials, <a href=";rank=4" target="_blank"><strong>DEFINE</strong></a> and <a href=";rank=8" target="_blank"><strong>CONFIRM</strong></a>, as well as an ongoing extension study, ENDORSE, in which some patients have been followed for up to six and a half years. Tecfidera has been clinically shown to significantly reduce important measures of disease activity, including relapses and the development of brain lesions, as well as to slow disability progression, while demonstrating a favourable safety and tolerability profile.</span></p> <p><span style="font-size: 10pt;"><br />Eli Silber,&nbsp;consultant neurologist at the King&rsquo;s Regional Neurosciences Centre, London says, &ldquo;Given that the average age of onset of the disease is in the early thirties, we are looking at a long disease course and considerable effects on work and family life. Tecfidera has the advantage of being a capsule&nbsp;and&nbsp;is an efficacious and convenient oral therapy. Multiple sclerosis is a long term condition and we are looking at long term therapies to prevent disease progression. Any new treatment that is&nbsp;effective&nbsp;and that makes the treatment process convenient for patients is welcome.&rdquo;<em>&nbsp;</em></span><span style="font-size: 10pt;"><br /><br />Tecfidera was first approved in the USA in March 2013, and approved in Canada and in Australia later that year.</span></p></div> The ALS Association announces new grants to investigate the causes of and treatments for ALS 2014-02-05T12:38:00Z 2014-02-05T12:38:00Z <div id="Introduction82" style="clear:both;"> <p><strong><span style="font-size: 11pt;">The ALS Association has announced the awarding of five new grants to investigate the causes and treatment of <span class="st"><strong>amyotrophic lateral sclerosis (ALS)</strong></span>. The ALS Association identified the focus of each of these grants as areas with high potential for progress.</span></strong></p> </div><div id="Text182" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">These grants are part of the TREAT ALS (Translational&nbsp;research&nbsp;advancing&nbsp;therapies for ALS) portfolio, which is a research endeavour enabling important global research to progress from the laboratory to the bedside. The focus of the programme is to support novel ideas, build tools, partner with academia and industry to identify new potential therapies and support the infrastructure for clinical trials with the goal to find meaningful treatments for ALS and a cure.</span></p> <p><br /><span style="font-size: 10pt;">The funded grants are:</span></p> <p><br /><span style="font-size: 10pt;">Palmitoylation of SOD1 and the pathogenesis of ALS</span><br /><span style="font-size: 10pt;"> Principal Investigators:&nbsp;Raymond Roos, M.D. and&nbsp;William Green, M.D.,&nbsp;University of Chicago, Chicago, USA.&nbsp;</span><br /><span style="font-size: 10pt;"> <em>Funded by The ALS Association, Greater Chicago Chapter, through the&nbsp;State of Illinois</em></span></p> <p><br /><span style="font-size: 10pt;">The investigators will determine whether a specific chemical change in the mutant SOD1 protein contributes to the misfolding of the protein that occurs in the disease. Mutations in SOD1 are one cause of familial ALS. Mutant protein misfolds, which is thought to contribute to the degeneration of motor neurons containing it. The investigators have discovered that mutant SOD1 undergoes a chemical change, called palmitoylation, more often than normal SOD1. They will examine the effect of this change on misfolding to determine if and how it contributes to the disease process and whether altering palmitoylation can be therapeutic.</span></p> <p><br /><span style="font-size: 10pt;">Corticospinal motor neuron developmental control genes as candidates for human ALS susceptibility</span><br /><span style="font-size: 10pt;"> Principal Investigators:&nbsp;Jeffrey Macklis, Ph.D. (Harvard University,&nbsp;Cambridge, USA.), and Ammar Al Chalabi, M.D. (Kings College,&nbsp;London, UK)</span><br /><span style="font-size: 10pt;"> <em>Additional funds have been provided toward this study by MNDA UK</em></span></p> <p><br /><span style="font-size: 10pt;">The development of motor neurons is under the control of a group of genes, each of which can exist in a variety of forms, or alleles. The specific set of alleles a person has may influence not only the development of their motor neurons, but also the susceptibility of those neurons to disease later in life, including ALS. The investigators will determine whether the alleles for these genes differ between people with ALS and those without it. Understanding whether and how developmental genes influence disease susceptibility will allow identification of many new targets for therapy.</span></p> <p><br /><span style="font-size: 10pt;">Cognitive change and ALS staging: The relationship between cognitive and motor system involvement in ALS</span><br /><span style="font-size: 10pt;"> Principal Investigators:&nbsp;Sharon Abrahams, Ph.D. (University of Edinburgh, Scotland);&nbsp;Ammar Al Chalabi, M.D. (Kings College,&nbsp;London, UK), and&nbsp;Orla Hardiman, M.D. (Trinity College, Dublin, Ireland)</span></p> <p><span style="font-size: 10pt;"><br />People with ALS may experience cognitive changes as part of their disease, and these changes may influence their physical abilities. In this study, researchers will develop a better understanding of those cognitive changes and their relationship to physical functioning during the disease course. The aim is to both better understand this interaction and to develop a new disease staging system incorporating both cognitive and physical changes that can be used in clinical trials to track response to therapy.</span></p> <p><br /><span style="font-size: 10pt;">AAV therapeutic agents for ALS</span><br /><span style="font-size: 10pt;"> Principal Investigator: Zuoshang Xu, M.D. Ph.D.,&nbsp;University of Massachusetts, USA.</span></p> <p><br /><span style="font-size: 10pt;">In this study, researchers will further develop a gene therapy delivery vehicle, or vector, using a new type of adeno-associated virus (AAV). AAV has been shown to be a versatile vector for reaching neurons in the central nervous system with a good safety record. Here, the scientists will develop the ability to pack a so-called &ldquo;interfering RNA&rdquo; into the vector and test its therapeutic ability in rats carrying a disease-causing SOD1 mutation. Success in this study will increase the rationale for development of gene therapy in people with ALS.</span></p> <p><br /><span style="font-size: 10pt;">Familial ALS exome capture and genomic sequencing collaboration</span><br /><span style="font-size: 10pt;"> Principal Investigators:&nbsp;Benjamin Neale, Ph.D. (Massachusetts&nbsp;General Hospital,&nbsp;Boston, USA) and&nbsp;Christopher Shaw, M.D. (Kings College&nbsp;London, UK)</span></p> <p><br /><span style="font-size: 10pt;">Several large-scale studies have produced volumes of data on gene variants associated with an increased risk for ALS. In this project, researchers will combine the data from those studies to better determine which of these gene variants is most strongly associated with disease. A key aspect of the research will be to stringently remove from consideration those variants that, despite some hint of association, are unlikely to be actually involved in ALS, thus streamlining the search for true risk genes. This project represents a major collaboration among multiple research groups, and its results will likely set the stage for developing much deeper insights into the genetics of ALS.</span></p></div> Stenting without post-dilation is a safe and feasible strategy in the carotid artery 2014-01-30T10:20:00Z 2014-01-30T10:20:00Z <div id="Introduction83" style="clear:both;"> <p><strong><span style="font-size: 11pt;">The results of a study published in the <a href="" target="_blank"><em>Journal of NeuroInterventional Surgery</em></a> have shown that carotid stenting without post-dilation is safe and effective.</span></strong></p> </div><div id="Text183" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Atshushi Ogata (department of Neurosurgery, Saga University, Japan) and others say that traditional carotid artery stenting involves post-dilation at the end phase of the intervention as there is a risk of embolic stroke caused by atheromatous plaque dislodgement. The authors explain that &ldquo;most emboli are produced during the post-dilation phase, which can occur if the balloon pushes the stent struts against the atheromatous plaque. Post-dilation is therefore considered to be the riskiest part of the procedure.&rdquo;<br /><br /></span><span style="font-size: 10pt;">Ogata and colleagues aimed, in their study, to demonstrate the safety and efficacy of carotid artery stenting without post-dilation.<br /><br /></span><span style="font-size: 10pt;">One hundred and sixty nine patients with 179 carotid artery stenoses between them, which were stented without post-dilation, were included in the study. A total of 108 lesions (61.4%) were symptomatic and 68 (38.6%) were asymptomatic. Two patients were excluded because the stenting had to be performed with post-dilation. The patient data was taken from a retrospective registry that ran between May 2005 and April 2012.<br /><br /></span><span style="font-size: 10pt;">&ldquo;Carotid artery stenting was performed successfully for all lesions, although major adverse events [stroke, myocardial infarction or death within 30 days] occurred in four patients (2.3%),&rdquo; note Ogata </span><em style="font-size: 10pt;">et al</em><span style="font-size: 10pt;">.<br /><br /></span><span style="font-size: 10pt;">The authors went on to say that the results show that the overall stroke rate was 2.3% within 30 days after carotid artery stenting, there were no myocardial infarctions and no patients died. Cerebral infarction occurred in two patients (1.1%) and transient ischaemic attack in three (1.7%).<br /><br /></span><span style="font-size: 10pt;">&ldquo;Our carotid artery procedure is effective, particularly in symptomatic patients. Although it might be possible to employ new types of stents and embolic protection devices in the future, concepts to minimise plaque disruption are important because plaque deposits remain contained in the vessel wall in carotid stenting procedures.&rdquo;<br /><br /></span><span style="font-size: 10pt;">They add that in 174 lesions (98.9%) closed-cell stents were used and in two lesions open-cell stents were used, therefore no advantage of open- over closed-cell stents could be observed.</span></p></div> Brain surgeon teams with NASA scientists to develop 3D high-definition surgical instruments 2014-01-29T11:06:00Z 2014-01-29T11:06:00Z <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><strong><span style="font-size: 11pt;">Brain surgeon Hrayr Shahinian (the Skull Base Institute, Los Angeles, USA), a pioneer in minimally invasive surgery, and NASA&rsquo;s Jet Propulsion Laboratory in Pasadena, USA, have introduced the next generation of high-tech surgical instruments to remove tumours and treat other brain abnormalities.</span></strong></p> </div><div id="Text184" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">MARVEL (Multi angle rear viewing endoscopic tool) captures and displays 3D high-definition images of the brain and enables surgeons to perceive depth and &ldquo;peek around corners&rdquo; that, until now, have been off limits, it says in a company release. These images allow surgeons to perform procedures quicker, safer and more precisely resulting in better outcomes and lower costs for both hospitals and patients. For NASA&rsquo;s Jet Propulsion Laboratory, the technology is expected improve future versions of the Mars Rover planetary explorer.<br /><br /></span><span style="font-size: 10pt;">This advancement marks the latest development in a move away from the more traditional open craniotomy. The procedure, used by neurosurgeons, involves removing large sections of skull to reach problem areas. According to the release, it is more costly than endoscopy and results in longer hospital stays and ongoing rehabilitation. Currently, more than 98% of all brain surgery in the USA is performed using the open craniotomy.<br /><br /></span><span style="font-size: 10pt;">&ldquo;This technology defines the future of our work in the operating room and on NASA missions,&rdquo; says Shahinian. &ldquo;The scientists at Jet Propulsion Laboratory and I are proud of our work which shows how the spirit of collaboration between two very different disciplines can benefit society as a whole.&rdquo;<br /><br /></span><span style="font-size: 10pt;">This minimally invasive approach has been adopted in other centres, including the Mayo Clinic, UCLA, USC and Johns Hopkins (all USA).</span></p></div> eNeura files 510(k) with the FDA for SpringTMS migraine treatment 2014-01-29T10:47:00Z 2014-01-29T10:47:00Z <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><strong><span style="font-size: 11pt;">eNeura has reported that it has filed a 510(k) with the US Food and Drug Administration (FDA) for the SpringTMS&nbsp;transcranial magnetic stimulation (TMS) device. SpringTMS is CE marked in&nbsp;Europe&nbsp;and available by prescription in the UK.</span></strong></p> </div><div id="Text185" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">SpringTMS is a second-generation medical device based on the company&rsquo;s CerenaTMS, which recently received FDA clearance for the treatment of pain caused by migraine headaches preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.&nbsp;SpringTMS, according to eNeura, is more patient-friendly and portable compared to the previous-generation device.<br /><br /></span><span style="font-size: 10pt;">CerenaTMS was the first medical device to be cleared by the FDA to treat migraine and SpringTMS operates along the same principles.&nbsp;The user applies TMS to the back of the head using both hands and presses a button to generate a focused, single pulse of magnetic energy that treats the migraine headache non-invasively and without discomfort.<br /><br /></span><span style="font-size: 10pt;">David K Rosen, president and CEO of eNeura, comments: &ldquo;As a company, our focus is to provide patients with innovative and effective TMS medical technologies.&nbsp;By filing a 510(k) with the FDA for SpringTMS we have completed the next step on the path to bringing our most advanced TMS device to patients in the USA. SpringTMS provides more user-friendly features compared to CerenaTMS, including a more compact size and shape, better portability and greater ease of use for the patient. We are optimistic that the SpringTMS will launch in 2014, having the advantage of improving upon our FDA-cleared predicate device.&rdquo;</span></p></div> Positive clinical performance of MS Precise for multiple sclerosis reported 2014-01-29T10:40:00Z 2014-01-29T10:40:00Z <div id="Introduction86" style="clear:both;"> <p><strong><span style="font-size: 11pt;">New data has been reported supporting the clinical validation of&nbsp;MS&nbsp;Precise (DioGenix), a next-generation sequencing assay for the identification of patients with multiple sclerosis at first clinical presentation.&nbsp;</span></strong></p> </div><div id="Text186" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">The prospective study met its primary endpoint by demonstrating the ability of&nbsp;MS&nbsp;Precise&nbsp;to diagnose patients with multiple sclerosis.&nbsp;The test<strong>&nbsp;</strong>performed consistently with previous clinical studies, having a specificity of 82% while maintaining sensitivity comparable previously published on the current standard of care (p=0.0027).<br /><br /></span><span style="font-size: 10pt;">Over 200 subjects who were being evaluated for non-specific neurological symptoms that could be multiple sclerosis were enrolled in the prospective, blinded clinical trial</span><em style="font-size: 10pt;">.</em><span style="font-size: 10pt;">&nbsp;Each subject was undergoing a comprehensive evaluation using the current standard of care for imaging of the central nervous system and analysis of their cerebral spinal fluid and blood.<br /><br /></span><span style="font-size: 10pt;">The study compared the results of&nbsp;MS&nbsp;Precise&nbsp;DNA mutational analysis with a consensus diagnosis made by a panel of independent neurologists. According to the company, the&nbsp;MS&nbsp;Precise&nbsp;interpretive scoring system provides a simple scaled score to the neurologist who differentiates patients with the disease from those with other similarly presenting neurological diseases. Thirteen multiple sclerosis clinical centres of excellence participated in the trial&mdash;believed to be the largest prospective diagnostic study of its kind in multiple sclerosis. Results from this study are expected to be submitted for peer review.<br /><br /></span><span style="font-size: 10pt;">&ldquo;MS&nbsp;Precise&nbsp;interrogates key genes involved in the immune system of patients being evaluated for multiple sclerosis. The growing body of evidence indicates this next-generation sequencing assay may advance our efforts to more accurately diagnose patients with the disease or other immune-mediated neurological disease,&rdquo; explains&nbsp;Elliot M Frohman, professor of Neurology and Ophthalmology and director, MS Program and Clinical Center for MS at The&nbsp;University of Texas Southwestern Medical Center, USA.<br /><br /></span><span style="font-size: 10pt;">These results are consistent with two prior DioGenix studies that compared&nbsp;MS&nbsp;Precise&nbsp;to published performance data for the oligoclonal banding test and experimental controls. In a previous, retrospective verification study,&nbsp;MS&nbsp;Precise&nbsp;demonstrated a clear improvement in the ability to classify early-stage multiple sclerosis patients from those with other similarly presenting neurological diseases in comparison to the oligoclonal banding analysis.<br /><br /></span><span style="font-size: 10pt;">&ldquo;DioGenix continues to clearly demonstrate the power of&nbsp;MS&nbsp;Precise&nbsp;to accurately identify patients with neurodegenerative diseases like multiple sclerosis. It&nbsp;should offer neurologists greater insight into early disease events by exploiting the incredible biological resolution provided by next-generation sequencing. As we are able to now more accurately measure these key early biological changes, we believe we can help inform more appropriate courses of treatment for individuals who suffer from these types of immune-mediated diseases,&rdquo; adds&nbsp;Larry Tiffany, president and CEO of DioGenix. &ldquo;The positive results of our validation study give us a green light to initiate our pre-commercial strategy.&rdquo;</span></p></div> Canadian collaboration to fund anti-hypertensive drugs for Alzheimer’s disease research 2014-01-29T10:07:00Z 2014-01-29T10:07:00Z <div id="Introduction87" style="clear:both;"> <p><strong><span style="font-size: 11pt;">A new funding collaboration to support a clinical trial investigating the potential for hypertension drugs to slow Alzheimer&rsquo;s disease progression has been announced between The <a href="" target="_blank">Alzheimer&rsquo;s Drug Discovery Foundation of Canada</a>&nbsp;and The <a href="" target="_blank">W Garfield Weston Foundation</a>. The trial will be led by Sandra Black (Sunnybrook Hospital, Toronto)&nbsp;and the <a href="" target="_blank">Toronto Dementia Research Alliance</a> at the&nbsp;University of Toronto, Canada.</span></strong></p> </div><div id="Text187" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">&ldquo;Hypertension has been suggested to be a risk factor for Alzheimer&rsquo;s disease for almost 30 years, yet we have not adequately translated this knowledge into the clinic for the benefit of patients. Black&rsquo;s study will begin to address this important issue in a novel study design, investigating the possibility that some anti-hypertensive agents may also be neuroprotective,&rdquo; says&nbsp;Howard Fillit, executive director and chief science officer of the Alzheimer&rsquo;s Drug Discovery Foundation. &ldquo;We are grateful to The W Garfield Weston Foundation for their collaboration in funding this important work.&rdquo;<br /><br /></span><span style="font-size: 10pt;">According to a press release, different classes of anti-hypertensive drugs may have different effects on the brain beyond blood pressure control. In the study, angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) will be compared for the treatment of hypertension in patients with Alzheimer&rsquo;s disease.&nbsp;ARBs, but not ACEIs, have been shown to both improve cognition in animal studies and interfere with disease processes involved in the development of Alzheimer&rsquo;s disease. Clinical trials designed to directly compare these two anti-hypertensive drug classes in patients with Alzheimer&rsquo;s disease have not yet been performed.<br /><br /></span><span style="font-size: 10pt;">&ldquo;Our exploratory clinical study will compare ARBs vs. ACEIs in a &lsquo;face-off&rsquo; to slow brain degeneration in people with Alzheimer&rsquo;s disease who are already taking medications to control blood pressure,&rdquo; says Black, the executive director of the Toronto Dementia Research Alliance and research programme director at Sunnybrook Research Institute at the&nbsp;University of Toronto. &ldquo;We will use brain imaging, and measure cognition and quality of life over a one year period to compare the rate of brain shrinkage in the people on ACEIs vs. ARBs.&rdquo;</span></p> <p><span style="font-size: 10pt;">Funding for this trial, which will cost&nbsp;US$992,388, was made possible through a grant by The W Garfield Weston Foundation.<br /><br /></span><span style="font-size: 10pt;">&ldquo;With a new mandate to accelerate the development of safe and effective breakthrough treatments for neurodegenerative diseases, The W Garfield Weston Foundation is pleased to support Black&rsquo;s compelling research through Alzheimer&rsquo;s Drug Discovery Foundation,&rdquo; adds W Galen Weston, chairman and president of The W Garfield Weston Foundation.&nbsp;</span></p></div> Myelin Repair Foundation and NIH enter into agreement to repurpose MRF-008 for multiple sclerosis 2014-01-29T09:43:00Z 2014-01-29T09:43:00Z <div id="ImageMain88" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction88" style="clear:both;"> <p><strong><span style="font-size: 11pt;">The&nbsp;<a href="" target="_blank">Myelin Repair Foundation</a> has announced that it has entered a Cooperative Research and Development Agreement (CRADA) with the&nbsp;<a href="" target="_blank">National Institutes of Health</a> (NIH)&nbsp;to assess MRF-008, as a potential therapeutic for multiple sclerosis.&nbsp;</span></strong></p> </div><div id="Text188" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, this CRADA will facilitate collaboration between the foundation and&nbsp;<a href="" target="_blank">National Institute of Neurological Disorders and Stroke</a> (NINDS)&nbsp;at the NIH Clinical Center to study MRF-008, a drug identified by the Myelin Repair Foundation as a potential neuroprotective therapeutic to enhance repair in multiple sclerosis patients.<br /><br /></span><span style="font-size: 10pt;">Through its&nbsp;Accelerated Research Collaboration (ARC) model, a collaborative research model designed to accelerate promising therapeutics to market, the Myelin Repair Foundation will work closely with the NIH to assess MRF-008 as a therapeutic candidate in an multiple sclerosis clinical trial. MRF-008 is a generic US Food and Drug Administration (FDA)-approved compound for the treatment of hypertension identified by the Myelin Repair Foundation&rsquo;s academic research consortium as a novel drug repurposing candidate for neuroprotection to stimulate multiple sclerosis repair. Irene Cortese and Daniel Reich have been named as leaders of the research study at the NIH.<br /><br /></span><span style="font-size: 10pt;">&ldquo;As a non-profit organisation beholden to patients, not profits, we are uniquely positioned to advance MRF-008, a generic drug identified by the Myelin Repair Foundation academic consortium, forward as a novel therapeutic candidate to stimulate repair for multiple sclerosis,&rdquo; said Scott Johnson, CEO, president and founder of the Myelin Repair Foundation. &ldquo;With the NIH&rsquo;s eminent expertise in multiple sclerosis clinical trials, we have found an exemplary partner to conduct the research necessary to assess MRF-008. With world-class advisors, academic scientists, industry partners and this opportunity to collaborate with NIH scientists, we remain on track to develop and deliver the next generation of multiple sclerosis therapeutics for patients.&rdquo;</span></p></div> NICE recommends Aubagio for multiple sclerosis 2014-01-24T12:25:00Z 2014-01-24T12:25:00Z <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>In&nbsp;final guidance,&nbsp;the&nbsp;<a href="" target="_blank">National Institute for Health and Care Excellence</a>&nbsp;(NICE) has&nbsp;recommended&nbsp;the use of Genzyme&rsquo;s multiple sclerosis drug teriflunomide (also called Aubagio) for adults with relapsing-remitting multiple sclerosis.</strong></span></p> </div><div id="Text189" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">According to a press release, the NHS now has a legal obligation to begin funding this treatment for eligible patients within the next three months.<br /><br /></span><span style="font-size: 10pt;">&ldquo;Current treatments all need to be injected, and can be associated with unpleasant side effects. As an oral treatment with a different side-effect profile, teriflunomide offers a new option for treating relapsing-remitting multiple sclerosis, which could have a substantial impact on quality of life for people with the disease,&rdquo; says Carole Longson, NICE Health Technology Evaluation Centre director.&nbsp;<br /><br /></span><span style="font-size: 10pt;">Teriflunomide is recommended for treating adults with active relapsing-remitting multiple sclerosis (normally defined as two clinically significant relapses in the previous two years) if they do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis and the manufacturer provides teriflunomide with the discount agreed in the patient access scheme.<br /><br /></span><span style="font-size: 10pt;">Nick Rijke, director for policy and research at the<a href="" target="_blank"> Multiple Sclerosis&nbsp;Society </a>comments:&nbsp;&ldquo;We have been waiting a long time for a tablet to be available for early stage multiple sclerosis, so this is excellent news. As well as making another valuable treatment available for people with the disease, many people will be delighted to have the option of a tablet rather than regular injections, which can be difficult to manage.&rdquo;</span></p></div> Transcranial magnetic stimulation a “breakthrough treatment” for migraine patients 2014-01-24T12:15:00Z 2014-01-24T12:15:00Z <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>In NHS guidance, the&nbsp;<a href="" target="_blank">National Institute for Health and Care Excellence</a>&nbsp;(NICE) has announced the results from clinical trials investigating a portable transcranial magnetic device for the treatment of migraine (SpringTMS, eNeura). The trials aimed to prevent or treat acute migraine among sufferers of pain, visual disturbance or sickness.</strong></span></p> </div><div id="Text190" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">In one of the controlled trials, which included 164 patients who were treated with single transcranial magnetic stimulation for at least one attack of migraine with visual disturbance, it was found that&nbsp;39% of patients experienced pain-free levels at two hours. The pain-free rate at 24 hours was 29% and at 48 hours, 27%.<br /><br /></span><span style="font-size: 10pt;">In a separate study, three quarters of patients with migraine who were repeatedly treated with the transcranial magnetic device had a reduction in headache frequency, including those with chronic migraine.<br /><br /></span><span style="font-size: 10pt;">According to a press release, the device may prove appropriate for those who find alternatives ineffective, or unsuitable, such as during pregnancy.<br /><br /></span><span style="font-size: 10pt;">Peter Goadsby, chair of the <a href="" target="_blank">British Association for the Study of Headache</a>,&nbsp;and director of the National Headache Centre at King&rsquo;s College Hospital in London, UK, says:&nbsp;&ldquo;Single pulse transcranial magnetic stimulation is a wonderful example of clinical and laboratory research delivering a real improvement in migraine treatment that is both effective and extremely well tolerated. Many patients are going to get real benefit from this device.&rdquo;<br /><br /></span><span style="font-size: 10pt;">Consultant neurologist Fayyaz Ahmed, a trustee of <a href="" target="_blank">The Migraine Trust</a>, adds: &ldquo;This is a breakthrough treatment for those who cannot tolerate or do not respond to current treatment, and opens the door for a new era in treating migraine headaches.&nbsp;We welcome NICE guidance and very much hope this treatment is made available to those in need.&rdquo;<br /><br /></span><span style="font-size: 10pt;">Wendy Thomas, chief executive at the charity The Migraine Trust, says: &ldquo;Huge numbers of sufferers find their lives blighted by migraine. We welcome NICE guidance that may help deliver brighter futures to many people for whom other treatments have not worked.&rdquo;</span></p></div> Kessler Foundation neuroimaging study sheds light on mechanisms of cognitive fatigue in multiple sclerosis 2014-01-24T12:03:00Z 2014-01-24T12:03:00Z <div id="ImageMain91" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Text191" style="clear:both; text-align:left"><p><strong><span style="font-size: 10pt;"><span style="font-size: 11pt;">The study: &ldquo;Examination of cognitive fatigue in multiple sclerosis using functional magnetic resonance imaging and diffusion tensor imaging&rdquo; by Helen M Genova, research scientist in neuropsychology and neuroscience research at Kessler Foundation, USA, and others sheds light on the mechanisms of underlying cognitive fatigue in patients with multiple sclerosis.</span><br /><br /></span></strong><span style="font-size: 10pt;">Published on 1 November 2013 in </span><a href="" target="_blank"><em style="font-size: 10pt;">PlosOne</em></a><span style="font-size: 10pt;">, this is the first study to use neuroimaging to investigate aspects of cognitive fatigue, it says in a press release.&nbsp;The study was funded by grants from the <a href="" target="_blank">National Multiple Sclerosis Society</a> (USA) and Kessler Foundation. The findings of the study supports the that the part&nbsp;striato-thalamic-frontal cortical system plays in fatigue, suggesting a &ldquo;fatigue-network&rdquo; in multiple sclerosis.<br /><br /></span><span style="font-size: 10pt;">The study investigated the neural correlates of cognitive fatigue in multiple sclerosis, utilising three neuroimaging approaches: functional magnetic resonance imaging (fMRI), which allows researchers to look at where in the brain activation is associated with a task or an experience; diffusion tensor imaging (DTI), which allows researchers to look at the health of the brain&rsquo;s white matter and; voxel-based morphometry</span><em style="font-size: 10pt;"> (</em><span style="font-size: 10pt;">VBM), which allows researchers to investigate structural changes in the brain.<br /><br /></span><span style="font-size: 10pt;">These three approaches were used to examine how likely it is for an individual to report fatigue (&ldquo;trait&rdquo; fatigue), as well as the fatigue an individual feels in the moment (&ldquo;state&rdquo; fatigue). According to the press release, this is the first study to use neuroimaging to investigate these two, separable aspects of fatigue.<br /><br /></span><span style="font-size: 10pt;">&ldquo;We looked specifically at the relationship between individuals&rsquo; self-reported fatigue and objective measures of cognitive fatigue using state-of-the-art neuroimaging,&rdquo; explains Genova. &ldquo;The importance of this work lies in the fact that it demonstrates that the subjective feeling of fatigue can be related to brain activation in specific brain regions. This provides us with an objective measure of fatigue, which will have incalculable value as we begin to test interventions designed to alleviate fatigue.&rdquo;<br /><br /></span><span style="font-size: 10pt;">In experiment one, patients were scanned during performance of a task designed to induce cognitive fatigue.&nbsp;Investigators looked at the brain activation associated with state fatigue.&nbsp;In experiment two, DTI was used to examine where in the brain white matter damage correlated with increased trait fatigue in individuals with multiple sclerosis, as assessed by the fatigue severity scale. The findings of both the experiments support the role of a striato-thalamic-frontal cortical system in fatigue, suggesting a &ldquo;fatigue-network&rdquo; in multiple sclerosis.<br /><br /></span><span style="font-size: 10pt;">&ldquo;Identifying a network of fatigue-related brain regions could reframe the current construct of cognitive fatigue and help define the pathophysiology of this multifaceted yet elusive symptom of multiple sclerosis,&rdquo; says&nbsp;John DeLuca, vice president of research and training at Kessler Foundation. &ldquo;Replication of these findings with larger sample sizes will be an important next step.&rdquo;</span></p></div> Take head injuries seriously, says NICE 2014-01-24T11:43:00Z 2014-01-24T11:43:00Z <div id="ImageMain92" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Introduction92" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Time is of the essence when treating head injuries to avoid potentially serious complications, including disability or death, says the&nbsp;<a href="" target="_blank">National Institute for Health and Care Excellence</a>&nbsp;(NICE). Its&nbsp;updated guidance&nbsp;on the issue emphasises the importance of early detection and prompt treatment for both children and adults who have suffered trauma to the head.</strong></span></p> </div><div id="Text192" style="clear:both; text-align:left"><div> <p><span style="font-size: 10pt;">Mark Baker, director of the Centre for Clinical Practice at NICE says:&nbsp;&ldquo;Over the past year media attention has focused on several high-profile people who have suffered potentially serious head injuries but waited several hours before seeking medical attention. These incidents should act as a warning that any head injury needs to be taken seriously and treated quickly.<br /><br />Although a person may appear fine at first, it is not uncommon for symptoms of a head injury to affect them some hours after the trauma took place. This updated guidance will ensure the NHS has the necessary processes in place to diagnose and treat head injuries in a timely manner, which will play a major part in saving the lives of people who have suffered a serious blow to the head.&rdquo;<br /><br /></span><span style="font-size: 10pt;">James Robson, national team doctor for the Scottish Rugby Union and head doctor during the British and Irish Lions tour to Australia last year, backs the updated guideline states:&nbsp;&ldquo;The NICE 2014 guidelines on head injury are a welcome release at a time of unprecedented activity on this issue in sport both nationally and internationally.<br /><br /></span><span style="font-size: 10pt;">&ldquo;The guidelines should be a required read for all professionals involved in the management of head injury before a patient is taken to hospital and once they are there; and in particular for myself and other colleagues, in the sporting arena.<br /><br /></span><span style="font-size: 10pt;">&ldquo;This document will form a reference source for evidence-based assessment and care of some of our most vulnerable patients, and will add great value to the debate, education, and research in this important area. The guidance on head injury triage, assessment, investigation, and early management should form the basis for the development of specific local protocols, ensuring that best practice and care is available to all, wherever their need may arise. We only have one head, use it not lose it.&rdquo;<br /><br /></span><span style="font-size: 10pt;">Key changes and updates in the guidance include:</span></p> </div> <div> <ul> <li><span style="font-size: 10pt;">Ambulance crews should take patients with a head injury straight to a hospital with resuscitation facilities where doctors and nurses can investigate and treat their injuries</span></li> <li><span style="font-size: 10pt;">Children and adults who have suffered a head injury but also begin to show particular signs that the injury may be serious or potentially life threatening (such as seizures, suspected skull fracture, repeated vomiting or loss of consciousness) should be undergo a computed tomography (CT) brain scan within one hour. Others should be scanned within four to eight hours of their injury, depending on its severity</span></li> <li><span style="font-size: 10pt;">A hospital doctor or specialist who is trained in safeguarding (for example, potential abuse) should be involved in checking any patient with a head injury presenting to accident and emergency, especially if it is a possible non-accidental injury or a vulnerable person has been injured</span></li> <li><span style="font-size: 10pt;">Doctors and nurses should give verbal and printed advice to patients, with any type of head injury who are discharged from an emergency department or observation ward, and their families and carers. Any advice should be accessible and appropriate to the patients&rsquo; age</span></li> </ul> </div> <div> <p><span style="font-size: 10pt;">&ldquo;Head injuries are the most common cause of death and disability in people up to the age of 40. How quickly a person receives treatment for their head injury can make all the difference to their life,&rdquo; comments Fiona Lecky, consultant in emergency medicine at the University of Sheffield, University of Manchester and Salford Royal NHS Foundation Trust and Chair of the GDG, UK.&nbsp;&ldquo;New technology and techniques means the NHS is able to assess people more quickly and care can be managed in more specialist centres. This updated guideline reflects the very best practice available, which I have no doubt will result in fewer people dying from their head injury.&rdquo;<br /><br /></span><span style="font-size: 10pt;">Peter McCabe, chief executive of <a href="" target="_blank">Headway&mdash;the brain injury association</a>, adds:&nbsp;&ldquo;We welcome these updated guidelines, particularly as they reinforce the need for high-quality written discharge information to be given to patients upon leaving hospital following a head injury.<br /><br /></span><span style="font-size: 10pt;">&ldquo;The unpredictability of head injuries demands the highest level of clinical excellence in the early stages of assessment and treatment and we hope these updated guidelines will ensure that is the case for all head injury patients.&rdquo;<br /><br /></span><span style="font-size: 10pt;">The&nbsp;updated guideline on head injury&nbsp;is primarily aimed at hospital doctors, nurses and ambulance crews, is now available from the <a href="" target="_blank">NICE website</a>.</span></p> </div></div> Vitamin D status associated with multiple sclerosis activity and progression 2014-01-21T09:37:00Z 2014-01-21T09:37:00Z <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>Vitamin D status appears to be associated with reduced disease activity in patients with multiple sclerosis and a slower rate of disease progression, according to a study published online first in&nbsp;<a href="" target="_blank"><em>JAMA Neurology</em></a>&nbsp;by Alberto Ascherio, Harvard School of Public Health, Boston, USA, and colleagues.</strong></span></p> </div><div id="Text193" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Multiple sclerosis is a common cause of neurological disability and vitamin D status may be related to the disease process, according to the study background.<br /><br /></span><span style="font-size: 10pt;">Researchers examined whether blood concentration of 25-hydroxyvitamin D (25[OH]D), a marker of vitamin D status, was associated with multiple sclerosis disease activity and progression in patients with a first episode suggestive of multiple sclerosis.<br /><br /></span><span style="font-size: 10pt;">Blood 25[OH]D levels were measured as part of a randomised trial originally designed to study patients given interferon beta-1b treatment. A total of 465 patients (of the 468 enrolled) had at least one 25[OH]D measurement. Patients were followed for up to five years with magnetic resonance imaging (MRI).<br /><br /></span><span style="font-size: 10pt;">Increases of 50-nmol/L in average blood 25[OH]D levels within the first 12 months appeared to be associated with a 57% lower risk of new active brain lesions, 57% lower risk of relapse, 25% lower yearly increase in T2 lesion volume and 0.41% lower yearly loss in brain volume from months 12 to 60.<br /><br /></span><span style="font-size: 10pt;">&ldquo;Among patients with multiple sclerosis mainly treated with interferon beta-1b, low 25[OH]D levels early in the disease course are a strong risk factor for long-term multiple sclerosis activity and progression,&rdquo; the study concludes.</span></p></div> Middle-school girls continue to play football with concussion symptoms, study finds 2014-01-21T09:21:00Z 2014-01-21T09:21:00Z <div id="Introduction94" style="clear:both;"> <p><span style="font-size: 11pt;"><strong>Concussions are common among middle-school girls who play soccer, and most continue to play with symptoms, according to a study published in&nbsp;<strong><a href="" target="_blank"><em>JAMA Pediatrics&nbsp;</em></a>and&nbsp;</strong>by John W O&rsquo; Kane, University of Washington Sports Medicine Clinic, Seattle, USA, and colleagues.</strong></span></p> </div><div id="Text194" style="clear:both; text-align:left"><p><span style="font-size: 10pt;">Sports-related concussions account for 1.6 to 3.8 million injuries in the USA annually, including about 50,000 football-related concussions among high school players. Injury-tracking systems for younger players are lacking so they are largely unstudied, according to the study background.<br /><br /></span><span style="font-size: 10pt;">Using an email survey and interviews, the authors evaluated the frequency and duration of concussions in young female football players, as well as whether the injuries resulted in stopping play and seeking medical attention. Their study included 351 football players (ages 11 to 14 years) from soccer clubs in the Puget Sound region of Washington, USA.<br /><br /></span><span style="font-size: 10pt;">Among 351 players, there were 59 concussions with 43,742 athletic exposure hours. Concussion symptoms can include memory loss, dizziness, drowsiness, headache and nausea. Cumulative concussion incidence was 13% per season with an incidence of 1.2 per 1,000 athletic exposure hours. Symptoms lasted a median four days (average 9.4 days). Heading the ball accounted for 30.5% of concussions. Most players (58.6%) continued to play with symptoms, with almost half (44.1%) seeking medical attention, according to the results.<br /><br /></span><span style="font-size: 10pt;">The authors note that the rate of 1.3 concussions per 1,000 athletic exposure hours was higher than what has been reported in other studies of girl&rsquo;s football at the high school and college levels.<br /><br /></span><span style="font-size: 10pt;">&ldquo;Future studies are needed to develop education strategies to ensure players understand and report concussion symptoms and that parents and coaches ensure appropriate medical evaluation and clearance before returning to play,&rdquo; the authors conclude. &ldquo;Future studies should also compare short- and long-term outcomes for those who seek medical care and return to play according to recommended guidelines vs. those who do not seek medical care and/or return to play prematurely.&rdquo;</span></p></div> Journal of the International Neuropsychological Society announces new editor-in-chief 2014-01-20T12:19:00Z 2014-01-20T12:19:00Z <div id="Text195" style="clear:both; text-align:left"><p><strong><span style="font-size: 11pt;">Stephen M Rao, the Ralph and Luci Schey chair and director of the Schey Center for Cognitive Neuroimaging at Cleveland Clinic, USA, has begun his tenure as the editor-in-chief of</span></strong><strong><span style="font-size: 11pt;">the</span><span style="font-size: 11pt;"><a href="" target="_blank"><em><strong> Journal of the International Neuropsychological Society</strong></em></a> (<em>JINS</em>).<br /></span></strong><span style="font-size: 11pt;"><br /></span><span style="font-size: 10pt;" data-mce-mark="1">Rao has previously served as one the journal&rsquo;s associate editors and has also served as the editor-in-chief of <a href="" target="_blank"><em>Neuropsychology</em></a>, published by the <a href="" target="_blank">American Psychological Association</a>.</span></p> <p><br /><span style="font-size: 10pt;">Rao has been a pioneer in the application of task-activated functional magnetic resonance imaging (MRI) to map the brain regions involved in memory, attention, temporal information processing, conceptual reasoning, and motor control in healthy older and younger participants. More recently, he has applied these brain mapping strategies to understand the prodromal phases of neurodegenerative conditions such as Alzheimer&rsquo;s and Huntington&rsquo;s diseases, and traumatic brain injury. He also has a long-standing interest in the study of cognitive, personality, and neuroimaging changes associated with multiple sclerosis.</span><br /><br /><span style="font-size: 10pt;">In preparation for assuming his current position, Rao reformatted the journal&rsquo;s editorial board and supervised a cover redesign. As his tenure progresses, he hopes to broaden the scope of topics covered by the journal.</span><br /><br /><span style="font-size: 10pt;">&ldquo;While maintaining the publication of high-quality, cutting-edge neuropsychology research initiated by Igor Grant and built upon by Kathleen Haaland, I also want the journal to include translational contributions from genetics, imaging, and cognitive neuroscience, disciplines that interface and advance our understanding of brain-behaviour relationships,&rdquo; says Rao. &ldquo;The innovative studies that have been and will be published in <em style="font-size: 10pt;">JINS</em> will have a meaningful impact on the direction of scientific inquiry for years to come.&rdquo;</span><br /><br /><span style="font-size: 10pt;">Gordon Chelune, executive secretary of the <a href="" target="_blank">International Neuropsychological Society </a>(INS) adds: &ldquo;We welcome Steve Rao to the few select who have served as our journal&rsquo;s editor-in-chief. His knowledge and experience will help guide <em style="font-size: 10pt;">JINS</em> through its next phase.&rdquo;</span><br /><br /><span style="font-size: 10pt;">&ldquo;It is a pleasure to be working with Rao again,&rdquo; said Jonathan Speilburg, editor, Cambridge University Press. &ldquo;We look forward to a long and fruitful editorial partnership, bringing the best research to an ever-widening audience.&rdquo;</span></p></div> Gene variation associated with brain atrophy in mild cognitive impairment 2014-01-20T11:58:00Z 2014-01-20T11:58:00Z <div id="ImageMain96" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Text196" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong><span style="font-size: 11pt;">The presence of a gene variant in people with mild cognitive impairment is associated with accelerated rates of brain atrophy, according to a new study published online in the journal <a href="" target="_blank"><em>Radiology</em></a>.</span></strong><br /><br /></span><span style="font-size: 10pt;">The study focuses on the gene apolipoprotein E (APOE). APOE has different alleles, says the study&rsquo;s senior author, Jeffrey R Petrella, associate professor of radiology at Duke University School of Medicine in Durham, USA. &ldquo;We all carry two APOE alleles, and most people have at least one copy of the APOE epsilon 3 (ɛ3) variant, which is considered neutral with respect to Alzheimer&rsquo;s risk&rdquo;.<br /><br /></span><span style="font-size: 10pt;">The less common epsilon 4 (ɛ4) allele, in contrast, is associated with a higher risk for development of Alzheimer&rsquo;s disease, earlier age of onset, and faster progression in those effected, as compared with the other APOE alleles.<br /><br /></span><span style="font-size: 10pt;">Petrella and colleagues recently analysed data from the Alzheimer&rsquo;s Disease Neuroimaging Initiative (ADNI) involving 237 patients, mean age 79.9, with mild cognitive impairment. The researchers used magnetic resonance imaging (MRI) to measure brain atrophy rates in these patients over a 12- to 48-month period.</span></p> <p><span style="font-size: 10pt;"><br /></span><span style="font-size: 10pt;">The ɛ4 carriers in the study group exhibited markedly greater atrophy rates than ɛ3 carriers in 13 of 15 brain regions hypothesised to be key components of the cognitive networks disrupted in Alzheimer&rsquo;s.<br /><br /></span><span style="font-size: 10pt;">&ldquo;The results showed atrophy in brain regions we know are affected by Alzheimer&rsquo;s disease, in a population of patients who do not have Alzheimer&rsquo;s disease, but are at risk for it,&rdquo; Petrella notes. &ldquo;This suggests the possibility of a genotype-specific network of related brain regions that undergo faster atrophy in mild cognitive impairment and potentially underlies the observed cognitive decline.&rdquo;<br /><br /></span><span style="font-size: 10pt;">The researchers did not explore why APOE ɛ4 might accelerate atrophy, but the effect is likely due to a combination of factors, adds Petrella.<br /><br /></span><span style="font-size: 10pt;">&ldquo;The protein has a broad role in the transport and normal metabolism of lipids and a protective function on behalf of brain cells, including its role in the breakdown of beta-amyloid, one of the proteins implicated in the pathophysiology of Alzheimer&rsquo;s disease,&rdquo; he says.<br /><br /></span><span style="font-size: 10pt;">With MRI playing an increasingly prominent role in mild cognitive impairment research, Petrella predicts that increased knowledge about the effects of APOE will improve the design and execution of future clinical trials. For instance, researchers could enrich their samples with &epsilon;4 patients in mild cognitive impairment prevention trials to better determine potential treatment effects on brain regions vulnerable to degeneration.<br /><br /></span><span style="font-size: 10pt;">The advances in knowledge are expected to help expand the role of MRI measures in clinical trials investigating novel drugs with potentially disease-modifying capabilities.<br /><br /></span><span style="font-size: 10pt;">&ldquo;Current US Food and Drug Administration-approved drugs treat symptoms, but do not modify the underlying cause of the disease,&rdquo; Petrella states. &ldquo;We want to make continued inroads toward the goal of developing and testing drugs that modify the disease process itself.&rdquo;</span></p></div> 13,000 patients treated with Visius surgical theatre since 2005, study indicates 2014-01-16T11:18:00Z 2014-01-16T11:18:00Z <div id="ImageMain97" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Text197" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong><span style="font-size: 11pt;">Results of an internal study of 40 worldwide Visius surgical theatre hospital customers indicates that nearly 13,000 patients have been treated using intraoperative MRI (iMRI) since the first installation in 2005</span></strong><br /><br /></span><span style="font-size: 10pt;">Four of 27 US hospitals, located in Boston, St. Louis and Minneapolis and St Paul, currently using Visius iMRI are approaching 1,000 cases performed.<br /><br /></span><span style="font-size: 10pt;">Frederick Boop, co-director of the Le Bonheur Neuroscience Institute in Memphis, USA, credits VISIUS iMRI with reducing reoperation rates. &ldquo;Intraoperative MRI is an important tool in our paediatric programme by&nbsp; allowing us to get a more complete removal of these tumours and better&nbsp; overall visualisation without moving the patient and knowing we will not&nbsp; have to bring the patient back for another operation,&rdquo; he says.<br /><br /></span><span style="font-size: 10pt;">Imris president and CEO Jay D Miller states that the company estimates the volume will be almost 17,000 by the end of 2014, an increase of around 31% in one year over the previous eight years.<br /><br /></span><span style="font-size: 10pt;">&ldquo;With increasing adoption and utilisation, more neurosurgeons and hospitals are recognising the decision support advantage of enhanced visualisation in the intraoperative setting and reduced risks associated with not moving patients for imaging,&rdquo; he says.</span></p> <p><span style="font-size: 10pt;"><br /></span><span style="font-size: 10pt;">&ldquo;The top neurosurgical hospitals are making the Imris solution their standard of care and not only increasing the number of procedures completed in the suite,&rdquo; Miller adds, &ldquo;but also expanding the types of applications and conditions other than various brain tumours, such as epilepsy, Parkinson&rsquo;s disease, stroke intervention, aneurysm, and&nbsp; Chiari malformation, and other neurological procedures using deep brain&nbsp; stimulation, ablation and other technologies with iMRI. Also, the recent addition of Visius iCT expands our solution into spinal conditions, trauma and intricate reconstructions.&rdquo;<br /><br /></span><span style="font-size: 10pt;">According to the company, inside a Visius surgical theatre equipped with either high-field iMRI or&nbsp; 64-slice intraoperative computed tomography (iCT), surgeons have&nbsp; on-demand access to real-time data and imaging, during&nbsp; the procedure from the operating room table. The MRI and CT imaging solution are said by the company to move on ceiling-mounted rails to enter or exit the operating room which mitigates known risks of moving critically-ill patients.<br /><br /></span><span style="font-size: 10pt;">Surgeons using iMRI for brain tumour removal have reported outcomes of more complete resection and reduced paediatric re-operation rates. Data published in 2011 shows 93% of iMRI glioma cases achieved gross or near total resection compared to 65% for non-iMRI cases in the same timeframe. A separate study indicated the need for repeat surgeries decreased with 8% of non-iMRI patients requiring re-operation within two weeks post procedure compared to zero re-surgeries for iMRI patients.</span></p></div> Stryker and NeuroLogica partner to provide surgical navigation with the BodyTom portable CT scanner 2014-01-16T10:46:00Z 2014-01-16T10:46:00Z <div id="ImageMain98" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Text198" style="clear:both; text-align:left"><p><span style="font-size: 11pt;"><strong>Stryker and NeuroLogica have announced an exclusive partnership agreement in which Stryker will promote and sell NeuroLogica&rsquo;s BodyTom portable full-body computed tomography (CT) scanner for the specialties of neurosurgery, spine surgery, orthopaedic surgery, and trauma surgery in conjunction with the Stryker NAV3i surgical navigation platform</strong></span><br /><span style="font-size: 11pt;"><br /></span><span style="font-size: 10pt;">According to the company, BodyTom is the world&rsquo;s first portable, 32-slice full body CT scanner. With an 85cm gantry and 60cm field of view, BodyTom produces high-quality diagnostic images throughout the hospital, including in the operating theatre where it is used to provide point-of-care imaging for surgical procedures. BodyTom can be combined with surgical navigation (image-guided surgery) to facilitate the guidance of surgical instruments relative to a patient&rsquo;s anatomy, improving visualisation and precision during minimally invasive surgical interventions.<br /><br />&ldquo;Stryker Navigation and NeuroLogica share a commitment to offering the most advanced technologies to assist surgeons in the operating theatre and deliver better outcomes for their patients,&rdquo; says Derek Babin, director of marketing for Stryker Navigation.<br /><br />&ldquo;We are excited to partner with NeuroLogica to provide streamlined and integrated surgical solutions to our customers that will enhance the surgeon experience and simplify the purchasing process for hospitals.&rdquo;<br /><br />&ldquo;The integration of Stryker Navigation with the BodyTom CT scanner is really very exciting,&rdquo; states Johnny Delashaw, neurosurgeon, Swedish Neuroscience Institute, Seattle, USA. &ldquo;The opportunity here is to be more accurate when we place our hardware in the spine and then reconfirm that our hardware is in a great position before we ever leave the room.&rdquo;</span></p></div> Research confirms effectiveness of Cognigram, a new test for Alzheimer’s disease 2014-01-16T10:32:00Z 2014-01-16T10:32:00Z <div id="Text199" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong><span style="font-size: 11pt;">A study from Australia, published online first in <a href="" target="_blank"><em>BMC Psychology</em></a>, has confirmed the effectiveness a new test for Alzheimer&rsquo;s disease. The test is said to detect cognitive decline in patients by scoring attention/reaction and learning/memory and comparing the scores to traditional cognitive impairment indicators</span></strong><br /><br /></span><span style="font-size: 10pt;">To detect the early signs of mild cognitive impairment which may lead to forms of dementia, including Alzheimer&rsquo;s disease, there is a need for a standardised test that can alert physicians to a possible cognitive decline, it says in a press release. Recent research from the Florey Institute of Neuroscience and Mental Health in Australia reported that a brief, online set of cognitive tests (</span><span style="font-size: 10pt;">Cognigram</span><span style="font-size: 10pt;">; Cogstate) can detect early signs of mild cognitive impairment and Alzheimer&rsquo;s.<br /><br /></span><span style="font-size: 10pt;">According to the release, Cognigram is available to primary-care physicians to provide a dementia test at the point of care in Canada through an exclusive agreement with Merck Canada. More than 580 primary care physicians have registered to use Cognigram and 20 testing centres are now live.<br /><br /></span><span style="font-size: 10pt;">To evaluate the functional health of a human brain, there needs to be observation of performance on several key domains, it states in the release. To assess the state of sub cortical brain regions including the basal ganglia as well as cortical regions such as the prefrontal and parietal cortices, tests of attention and reaction time are used. Learning and working memory depend on normal functioning of the hippocampus and temporal lobe (for pattern separation) and prefrontal cortex and anterior cingulate (for working memory).<br /><br /></span><span style="font-size: 10pt;">By grouping these two domains, attention/reaction and learning/memory, into composite scores, the research team, led </span><span style="font-size: 10pt;">Paul Maruff</span><span style="font-size: 10pt;">, chief science officer of Cogstate, were able to compare test results with traditional indicators of mild cognitive impairment and Alzheimer&rsquo;s.<br /><br /></span><span style="font-size: 10pt;">&ldquo;The presence of a relatively greater impairment in cognitive functions dependent on cortical and limbic brain regions (i.e. learning and working memory) with relatively subtle impairment in motor and attention functions is consistent with neuropsychological models of Alzheimer&rsquo;s disease which emphasise that cognitive impairment characteristic of both prodromal and clinically classified Alzheimer&rsquo;s disease is disruption to memory and executive function,&rdquo; says Maruff.<br /><br /></span><span style="font-size: 10pt;">To test this, they recruited volunteers from the <a href="" target="_blank">AIBL</a> (Australian imaging, biomarkers and lifestyle) study, dividing them into three groups; 653 healthy adults, 107 with amnesic mild cognitive impairment (where the primary symptom is memory loss), and 44 with Alzheimer&rsquo;s disease. They were all asked to complete the four tests of the Cogstate brief battery (also known as&nbsp;</span><span style="font-size: 10pt;">Cognigram</span><span style="font-size: 10pt;">), and the speed and accuracy of the results were recorded.<br /><br /></span><span style="font-size: 10pt;">All of the Cogstate tests use a deck of playing cards as their focus point. No knowledge of any card games is required, patients answer a yes/no question about what and when cards are shown to them. For the attention/reaction composite, volunteers completed a&nbsp;</span><span style="font-size: 10pt;">detection</span><span style="font-size: 10pt;">&nbsp;task, pressing a certain key on a computer keyboard as soon as a card is turned over, as well as an&nbsp;</span><span style="font-size: 10pt;">identification</span><span style="font-size: 10pt;">&nbsp;task, answering yes or no if a card turned over is the colour red.<br /><br /></span><span style="font-size: 10pt;">For the learning/working memory composite, two additional tests were used. The&nbsp;</span><span style="font-size: 10pt;">one-card learning</span><span style="font-size: 10pt;">&nbsp;task asks, &ldquo;Have you seen this card before in this task?&rdquo; To test immediate recall, the&nbsp;</span><span style="font-size: 10pt;">one back</span><span style="font-size: 10pt;">&nbsp;test asks if the card displayed is the same as the immediately prior card.<br /><br /></span><span style="font-size: 10pt;">The results showed that both the mild cognitive impairment and the Alzheimer&rsquo;s disease groups performed significantly worse on both composites than the healthy adults. Also, the Alzheimer&rsquo;s group&rsquo;s learning/memory score was significantly lower than the cognitive impairment group, demonstrating the presence and progression of the memory decline caused by the disease.<br /><br /></span><span style="font-size: 10pt;">To be a reliable diagnostic tool for physicians, it says in the release, the test battery needs to be able to show consistent results over time. The Cognigram testing was repeated four times in three months and showed statistically similar results across all groups.</span></p> <p><span style="font-size: 10pt;"><br /></span><span style="font-size: 10pt;">&ldquo;We are excited about the results of this study,&rdquo; comments Maruff. &ldquo;The Cogstate brief battery has been found to be sensitive to amyloid-related cognitive change in many trials. This study shows for the first time, that a version of the test designed specifically for clinical practice; the Cognigram battery, has excellent sensitivity and specificity to mild cognitive impairment.&rdquo;</span></p></div> Richard Hammond backs children’s brain injury book launch 2014-01-16T10:11:00Z 2014-01-16T10:11:00Z <div id="ImageMain100" style="clear:both;" align="center"><a href=""><img src="" border="0" vspace="5" /></a></div><div id="Text1100" style="clear:both; text-align:left"><p><span style="font-size: 10pt;"><strong><span style="font-size: 11pt;">Top Gear presenter Richard Hammond is backing the launch of a book launch aimed at helping youngsters and their parents to better understand brain injuries and their hidden effects, it was reported in a press release from the Children&rsquo;s Trust</span></strong><br /><br /></span><span style="font-size: 10pt;">According to the release, Hammond suffered a serious brain injury when he was involved in a high speed car crash. Brain injury has also featured in the news agenda after retired Formula One driver Michael Schumacher was involved in a skiing accident.</span></p> <p><span style="font-size: 10pt;">Hammond says he is proud to lend his support to the publications, which are now available and he has also made an audiobook to accompany one of the books.<br /><br /></span><span style="font-size: 10pt;">The publications include a parents&rsquo; handbook and two children&rsquo;s books, he comments: &ldquo;This is a wonderful, colourful way for families touched by brain injury to explore the issues they may face.&rdquo;<br /><br /></span><span style="font-size: 10pt;">The children&rsquo;s books are aimed at different age groups and are designed to empower children and help them in their rehabilitation journey. They have also been designed to encourage empathy among all youngsters towards other children or siblings who may be living with a brain injury, it says in the press release.<br /><br /></span><span style="font-size: 10pt;">&ldquo;Heads Up, Tim-Tron&rdquo; &nbsp;is one of the publications and explains acquired brain injury to young readers of primary school age. The book, which is accompanied by Richard&rsquo;s audiobook and according to the release, won the United Kingdom Acquired Brain Injury Forum innovation award. It was also chosen as The Book Trust&rsquo;s Bookmark book of the month.</span></p> <p><span style="font-size: 10pt;"><br /></span><span style="font-size: 10pt;">The books have been developed by The Children&rsquo;s Trust, a UK charity leading for children with acquired brain injury of which Hammond is vice president.</span></p> </div>