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Tuesday, May 20, 2014

For the first time, the U.S. Food and Drug Administration (FDA) has given the green light for the marketing of a prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes. These electrodes detect electrical activity from muscle contractions close to where the prosthesis is attached, and the electrical signals are then translated into specific movement(s) by a computer processor in the prosthesis.

The DEKA Arm System, a Defense Advanced Research Projects Agency (DARPA)-funded project intended to restore functionality for individuals with upper extremity amputations, can translate into up to 10 different movements. Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said, “The DEKA Arm System may allow some people to perform more complex tasks than they can with current prostheses in a way that more closely resembles the natural motion of the arm.”

For this approval, the FDA reviewed survey data and clinical information from a four-site Department of Veterans Affairs (VA) study of 36 participants using the DEKA Arm System. In all, about 90 percent of users reported that they were able to perform new activities that t
hat they were not able to perform with their current prosthesis, such as using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair. In one of the studies by the VA, 79 percent of the 24 individuals using the Gen 2 DEKA Arm and 85 percent of the 13 individuals using the Gen 3 DEKA Arm said they would want to receive or might want to receive a DEKA Arm. See additional research on the DEKA Arm here:

ustin Sanchez, a program manager in DARPA's biological technologies office, told
Reuters that DARPA had provided more than $40 million in funding to DEKA for the development of the prosthetic arm. "It was designed to produce near-natural upper extremity control to injured people who have suffered amputations. This arm system has the same size, weight, shape and grip strength as an adult's arm would be able to produce," he said.

     Tom Doyon, a project manager at DEKA, said that the company was "proud and excited" about the approval. "This approval allows us to now focus on manufacturing and bringing to market the arm system so that we can deliver it to those in most need of this amazing technology — in particular our wounded veterans."

According to the FDA, the DEKA Arm System can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm. However, it can’t be used for limb loss at the elbow or wrist joint. 

The DEKA Arm System is manufactured by DEKA Integrated Solutions in Manchester, N.H.

See previous coverage of the DEKA Arm System in Neurology Today:, as well as other advances in prosthetics

Friday, May 16, 2014
by Susan Fitzgerald

Houston is getting a “stroke ambulance” that is equipped with a CT scanner, laboratory, and neurologist ready to administer intravenous tissue plasminogen activator (tPA) on the way to the hospital to stroke patients who could benefit from the clot-busting drug.
The ambulance is modeled after units operating in Germany, where researchers reported encouraging results in reducing the amount of time that passes between when an ambulance is summoned and administration of tPA. The study, Prehospital Acute Neurological Treatment and Optimization of Medical care in Stroke Study (PHANTOM-S), compared use of specially outfitted ambulances designed to take full advantage of the so-called “golden hour,” the critical period right after stroke symptoms appear when it is most possible to limit brain damage, with conventional ambulance transports.

 A team of researchers in Berlin reported in the April 23/30 edition of Journal of the American Medical Association (JAMA) that there was, on average, a 25-minute reduction in alarm-to-treatment time; 51.8 minutes with tPA when the mobile stroke unit responded to a call as compared with 76.3 minutes when a regular ambulance service was in place. Also, the rate of tPA usage was 33 percent with the mobile stroke unit, significantly higher than the 21-percent rate during weeks of conventional emergency response.

“Our experience is that our pre-hospital stroke thrombolysis service is frequently used and safe,” Heinrich Audebert, MD, a professor of neurology at Charité University Hospital in Berlin and coauthor of the JAMA study, told Neurology Today. “It increases the thrombolysis rate and shortens the time to treatment.”

The Houston project is the brainchild of James Grotta, MD, FAAN, formerly the chair of neurology at University of Texas Health Science Center and the director of its stroke program. He is now based at Memorial Hermann-Texas Medical Center, where he is coordinating the launch of the stroke-response ambulance to service the Houston area. He became intrigued with the idea after learning of the initiatives in Germany.

“To me, the most effective way we can improve on what we are already doing with stroke care is to get patients to treatment earlier,” Dr. Grotta told Neurology Today, for which he serves as an editorial advisory board member. “No matter what we do, we’ve got to do it faster.”

Despite a number of public health campaigns to increase the awareness of stroke and its symptoms, many people are slow to call for help and do not show up at the emergency department until after the treatment window for tPA has closed, Dr. Grotta noted.

     The JAMA study reported on an emergency response vehicle named STEMO — the stroke emergency mobile — that is equipped with a CT scanner, point-of-care laboratory, telemedicine connection, a stroke identification algorithm at the dispatcher level, and a prehospital stroke team that includes a neurologist, paramedic, and radiology technician. The point-of-care laboratory offers tests for blood count, electrolytes,
creatinine, glucose, and international normalized ratio.

“Compared with usual care, the use of ambulance-based thrombolysis resulted in decreased time to treatment without an increase in adverse events,” the researchers reported. “Further studies are needed to assess the effects on clinical outcomes.”

     For a full analysis of the project and its feasibility, see the
May 15 issue of Neurology Today. See more articles on stroke in Neurology Now:

Thursday, May 15, 2014

By Gina Shaw

At first, the fact that almost two-thirds of Americans with Alzheimer’s disease are women would seem to have a simple explanation: women live longer than men (81 vs. 76 years average life expectancy in the US), and Alzheimer’s disease risk increases greatly with age.

But a new special report on women and Alzheimer’s disease, released by the Alzheimer’s Association as part of their larger annual report, 2014 Alzheimer’s Disease Facts and Figures, makes it clear that the significant gender gap in Alzheimer’s almost certainly cannot be explained by life expectancy alone.

As the report notes, women aged 65 have a one in six lifetime risk of developing Alzheimer’s, while men aged 65 have a one in 11 risk — a difference that can’t be accounted for simply by five years increased average lifespan.
To some extent, gender differences in Alzheimer’s rates may be explained by similar differences in cardiovascular disease rates. A recent analysis of data from the Framingham study — published in January in the Alzheimer’s Association journal, Alzheimer’s & Dementia — confirmed that men aged 45-65 have a higher rate of death from cardiovascular disease than women of the same age range. Since a high risk of cardiovascular disease is also associated with a high risk of developing Alzheimer’s disease, these early heart disease deaths among men means that a significant number of men who might otherwise have gone on to develop Alzheimer’s have died of heart disease before reaching age 65.

But again, the researchers on this analysis found that this effect explained only part of the difference in Alzheimer’s disease rates among women and men 65 and older — perhaps 20 to 50 percent. 

      So what else is at play here? It’s possible that these differences can all be explained by research methodology. “Several European studies showed higher incidence rates in women; however, studies in the United States did not show the difference,” Walter A. Rocca, MD, MPH, director of the Rochester Epidemiology Project at the Mayo Clinic, told Neurology Today. “The different pattern in Europe and the United States may be due to differences in the methodology used to conduct the study. On the other hand, the differences may be genuine, and may reflect a different distribution of risk and protective factors related to sex or gender across countries (or continents).”

      See the full discussion by Alzheimer’s experts
here in the May 1 issue of Neurology Today. Browse our archives for recent research advances in Alzheimer’s and dementia:

Wednesday, April 16, 2014

The National Institutes of Health (NIH) is celebrating the opening of the brand new Edward Porter Neuroscience Research Center, a state of the art research facility on NIH campus that will foster new collaborations among neuroscientists. A two-day scientific symposium and dedication ceremony is taking place today and tomorrow in order to celebrate this new facility, which will bring together neuroscientists from 10 institutes and centers across the NIH in hopes of advancing scientific understanding of the nervous system in health and disease. (A live broadcast of the event is available here.)

            The Center will bring together more than 800 scientists in 85 laboratories from the following NIH Institutes and Centers:

  • National Institute of Neurological Disorders and Stroke
  • National Institute of Mental Health
  • National Center for Complementary and Alternative Medicine
  • National Eye Institute
  • National Human Genome Research Institute
  • National Institute on Aging
  • National Institute of Biomedical Imaging and Bioengineering
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development
  • National Institute on Deafness and Other Communication Disorders
  • National Institute of Dental and Craniofacial Research

            The shared facilities available in the new center include a peptide sequencing facility, an MRI suite with one of the largest MRI devices in the world, and a light imaging facility. According to the NIH, collaborators at the Porter Center will carry out research into basic and clinical neuroscience, including:

  • Identifying how genetic variability contributes to neurological diseases such as Alzheimer’s, Parkinson's, and amyotrophic lateral sclerosis 
  • Studying the genetics of brain development, including factors that contribute to developmental disorders such as attention deficit hyperactivity disorder (ADHD)
  • Understanding how inherited gene mutations contribute to hearing loss
  • Studying the genetics of Gaucher disease as a model to understand lysosomal storage disorders
  • Working to understand the mechanisms underlying nerve cell death in neurodegenerative disorders and trying to identify drugs that can prevent this loss
  • Understanding the structure and function of ion channels and transporters that allow communication within and between nerve cells
  • Studying how nerve cells communicate to help us better understand how we learn and remember, and exploring diseases in which nerve cells do not communicate effectively
  • Using tools to turn on or turn off various neural circuits in model organisms to determine what role these circuits play in behaviors such as decision making
  • Using large-scale microscopy to develop maps of brain circuits of the central nervous system to better understand the basis of behavior
  • Using the olfactory system as a model to understand how the brain can regrow nerve cells and make new connections after disease or injury
  • Dissecting the neural basis of chronic pain

            The Center will also feature a public art gallery that will celebrate the intersection of neuroscience and art, with initial artwork by former NIH artist-in-residence Rebecca Kamen, MFA, a professor emeritus formerly at Northern Virginia Community College.

            The new building is named for John Edward Porter, a former congressman, member of the House Appropriations Committee, chair of the subcommittee that funded NIH, and a faithful supporter of biomedical research and the NIH mission, the NIH stated in a press release

            “The concept for this building first arose when we saw a need for a place that could bring together scientists studying all aspects of the brain. We are delighted that the Porter Neuroscience Research Center is officially open and look forward to the many innovative discoveries that are bound to come from the programs in that building,” said Story C. Landis, PhD, director of the National Institute of Neurological Disorders and Stroke.

            See more information about the new center at

Wednesday, April 16, 2014
For the first time, the US Food and Drug Administration (FDA) has approved the drug topiramate (Topamax) for migraine prevention in adolescents, ages 12 to 17. Topiramate is indicated for daily use in order to reduce the frequency of migraine headaches. The drug was first approved by the FDA in 1996 to prevent seizures. In 2004, topiramate was approved for migraine prevention in adults.

The approval is based on safety and efficacy data from a clinical trial of 103 adolescents (ages 12 to 17). The trial showed a significant decrease (p=0.016) in monthly migraine frequency in those individuals taking 100 mg of topiramate (72 percent) compared with those taking placebo (44 percent). The study was published in a 2009 edition of Pediatrics by Donald Lewis, MD, of Eastern Virginia Medical School, and colleagues.

Common adverse effects included paresthesia, upper respiratory infection, loss of appetite, and abdominal pain. The FDA warned that the drug should be dispensed with a Medication Guide that provides safety information about the drug. Some potentially serious side effects may include suicidal thoughts and behavior, depression, unusual changes in mood or behavior, and birth defects in infants born to women who take the drug during pregnancy. 

opiramate is manufactured by Janssen Pharmaceuticals, Inc. of Titusville, N.J.

      Read our previous stories on migraine in adolescents: