News Article | May 5, 2017
JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that data suggests that women with relapsing forms of multiple sclerosis (RMS) who were exposed to COPAXONE® 20 mg/mL daily during pregnancy are not at higher risk for congenital anomalies compared to reference rates for abnormal pregnancy outcomes reported in two large databases representing the general population. These data appeared as an “Online First” article on the Website of the International Journal of MS Care (IJMSC) and represent the largest published analysis of pregnancy pharmacovigilance data for an RMS treatment. MS is more common among women of childbearing age compared with any other age group. The average age of diagnosis is 30, and many women go on to have children after diagnosis. Approximately half of pregnancies are unintended, which means that women with MS may become pregnant unexpectedly while taking an MS treatment. None of the MS therapies are approved for use during pregnancy. “Physicians now have this data to consider as they consult with their RMS patients planning a family or already pregnant, to make individual treatment decisions,” said Patricia K. Coyle, M.D., professor and vice chair (clinical affairs) of neurology, and the director of the Multiple Sclerosis Comprehensive Care Center at the Stony Brook University Medical Center, Stony Brook, New York. The analysis published in IJMSC compared 5,025 pregnancy cases with known outcomes from the Glatiramer Acetate (GA) Pharmacovigilance Database to two other databases of healthy women, the Metropolitan Atlanta Congenital Defects Program (MACDP)1 and the European Surveillance of Congenital Anomalies (EUROCAT)2. When compared to the rate of congenital anomalies from the MACDP database, the rate for prospective pregnancies among women exposed to COPAXONE® while pregnant from the GA Pharmacovigilance Database was comparable to the general U.S. population. Similarly, the comparison between the GA Pharmacovigilance and EUROCAT data indicated that the rate of congenital anomalies is very similar to that of the general European population. “With more than 20 years of data collected on COPAXONE®, we are able to share this important analysis with physicians to consider and counsel their patients of child-bearing age,” said Rob Koremans, M.D., President and CEO, Teva Global Specialty Medicines. “We are pleased to put forward this data that may help facilitate that conversation.” The publication, “Pregnancy Outcomes from the Branded Glatiramer Acetate Pregnancy Database,” is available online at http://ijmsc.org/doi/abs/10.7224/1537-2073.2016-079. The International Journal of MS Care is the official peer-reviewed publication of the Consortium of Multiple Sclerosis Centers (CMSC). COPAXONE® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. COPAXONE® is rated as Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on offspring development. Animal reproduction studies are not always predictive of human response, therefore COPAXONE® should be used during pregnancy only if clearly needed. See additional important information at: www.CopaxonePrescribingInformation.com. For hardcopy releases, please see enclosed full prescribing information. The COPAXONE® brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries. Patients allergic to glatiramer acetate or mannitol should not take COPAXONE®. Some patients report a short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, patients should call the emergency phone number in their area. Patients should call their doctor right away if they develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, patients should not give themselves any more injections until their doctor tells them to begin again. Chest pain may occur either as part of the immediate postinjection reaction or on its own. This pain should only last a few minutes. Patients may experience more than one such episode, usually beginning at least one month after starting treatment. Patients should tell their doctor if they experience chest pain that lasts for a long time or feels very intense. A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Patients should follow proper injection technique and inform their doctor of any skin changes. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of COPAXONE®. For a complete list, patients should ask their doctor or pharmacist. Patients should tell their doctor about any side effects they have while taking COPAXONE®. Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential benefits of COPAXONE® which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 1 Population-based tracking system for birth defects. The MACDP was established in 1967 by the Centers for Disease Control and Prevention (CDC), Emory University, and the Georgia Mental Health Institute. 2 European network of population-based registries for the epidemiologic surveillance of congenital anomalies
News Article | May 8, 2017
International Neurologists and MS Researchers will Present Opening Lectures, May 24-27 The preeminent conference for multiple sclerosis health care professionals, the 31st Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, presents opening day lectures with some of the top minds in MS treatment, comprehensive care and research. Taking place May 24-27, at the Ernest N. Morial Convention Center in New Orleans, LA, the robust educational agenda includes opening lectures as well as panel discussions and continuing education programs for physicians, physician assistants, nurses, pharmacists, as well as mental health and rehabilitation professionals. “This year’s opening day lectures feature some of the leading authorities in MS care and research," said June Halper, CEO, Consortium of Multiple Sclerosis Centers (CMSC). “The world of MS diagnosis, treatment and care is evolving, and attendees at the CMSC Annual Meeting will be immersed in the latest care strategies and research findings that lead to optimal outcomes for patients.” Aaron L. Boster, MD, opens the CMSC Annual Meeting with the John F. Kurtzke Memorial Lecture on “MS Comprehensive Care: A Team Sport.” Dr. Boster is a board-certified clinical neuroimmunologist specializing in multiple sclerosis (MS). On Thursday, May 25th, the Presidential Lecture by Jeffrey A. Cohen, MD, will be on: “New McDonald Criteria.” Diagnostic criteria for multiple sclerosis have undergone successive revision and refinement, and an international consensus workshop recently was convened to assess the performance of the current 2010 McDonald Criteria. This presentation will summarize the discussions at the consensus workshop and the resultant proposed revisions to the McDonald Criteria. The John Whitaker Memorial Lecture takes place on Friday, May 26th. Jerry S. Wolinsky, MD, will moderate the lecture by Emmanuelle Waubant, MD, PhD, on: “How Research on Pediatric MS Can Inform Thoughts on MS Pathogenesis.” Brian G. Weinshenker, MD, will deliver the Donald Paty Memorial Lecture on Saturday, May 27, entitled: “Induction or Aggressive Treatment for Multiple Sclerosis: Is it Right for Most, Some or No Patients?” Dr. Weinshenker will discuss the arguments for aggressive treatments as well as the inherent risks and help clinicians develop a better understanding and knowledge when discussing aggressive treatment with patients. In addition to the daily opening lectures, the CMSC Annual Meeting presents unique educational opportunities that include clinical courses, symposia, poster sessions, platform presentations, roundtable discussions, and workshops. The informational and networking dinners on May 24th will include “Meet the Professor,” with Giancarlo Comi, MD, discussing "What is New in MS Treatment: The Benefits in Everyday Clinical Practice." There are also full courses on “Fundamentals of MS Care,” “Current Topics and Trends in MS Rehabilitation,” “Core Concepts for the MS Nurse,” and timely topics that include “MJ for MS? —An MS Health Professional’s Guide to Cannabis,” “CNS Repair and Ways to Measure It,” “Unique Wellness Approaches to Progressive MS,” “Controversies in Multiple Sclerosis Treatments,” “T Cells/ B Cells,” and “Invisible Symptoms: Depression, Cognitive Dysfunction.” The 31st CMSC Annual Meeting is the only North America event that provides health care professionals, from a wide range of medical disciplines and from all over the world, with the latest information, treatment advancements, and research in comprehensive care in multiple sclerosis. For more information on the CMSC Annual Meeting and to register, visit: http://www.mscare.org/2017 ABOUT THE CONSORTIUM OF MULTIPLE SCLEROSIS CENTERS (CMSC) CMSC, the Consortium of Multiple Sclerosis Centers, is the leading educational, training, and networking organization for MS healthcare professionals and researchers. The CMSC mission is to promote high-quality MS care through educational programming and accreditation including live and online events, research grants, technical journals and papers, and targeted advocacy efforts. The CMSC member network includes more than 11,000 international healthcare clinicians and scientists committed to MS care as well as more than 60 Veterans Administration MS Programs and 225 MS Centers in the US, Canada, and Europe. The 31st CMSC Annual Meeting, the largest gathering of MS professionals in North America, will take place May 24-27, in New Orleans, LA. For more information go to www.mscare.org. Follow CMSC on Twitter: @mscare.org and Facebook: CMSCmscare. Editor’s Note and PR Contact: If you would like to attend the CMSC Annual Meeting as a member of the media, please contact Annie Scully at firstname.lastname@example.org, 201-310-9252
News Article | February 15, 2017
Today, BESLER Consulting announced the publication of "Three Ways To Succeed Under Episode Payment Models (EPMs)." In November, 2015, CMS introduced the Comprehensive Care for Joint Replacement (CJR) bundled payment program. Subsequently, CMS has announced the introduction of three new EPMs including services for acute myocardial infarction (AMI), coronary artery bypass graft (CABG), and surgical hip/femur fracture treatment (SHFFT). This special report discusses EPM programs currently offered by the Centers for Medicare and Medicaid Services (CMS) and three ways hospitals can succeed under these new programs. “The landscape for hospital reimbursement is rapidly changing from a fee-for-service environment to a value-based system,” said Jonathan Besler, President & CEO of BESLER Consulting. “We published this report to help illuminate some of the strategies hospitals can use to navigate these changes.” For a copy of this free report visit the BESLER Consulting website at besler.com/epm. About BESLER Consulting BESLER Consulting combines broad healthcare finance expertise with cutting-edge technology to help hospitals enhance and protect their revenue. Through reimbursement and revenue recovery initiatives to navigating alternative payment models, our efforts have delivered more than $2 billion of additional revenue to hospitals across the United States. BESLER’s Transfer DRG Revenue Recovery Service has earned the coveted Peer Reviewed designation from the Healthcare Financial Management Association and we proudly count hundreds of hospitals among our satisfied customers. For more information, visit http://www.besler.com.
News Article | February 15, 2017
To eat soy or not: That's the question many U.S. women have been asking. Tofu, miso paste and other soybean-based foods are high-quality sources of protein that are low in calories and saturated fat. And studies have shown that they can help prevent cancer. Yet many doctors recommend that women who have, or are at risk of developing, a common form of breast cancer called estrogen-receptor-positive breast cancer avoid eating soybean-based foods because they contain compounds called isoflavones. Some studies suggest that isoflavones can mimic the hormone estrogen and encourage tumor growth. Now, in an animal study, researchers at the Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C., have uncovered a possible reason for the apparent Jekyll-and-Hyde nature of soy — how it can both prevent cancer and fuel its spread. [Top 10 Cancer-Fighting Foods] The researchers found that rats that were given soybean isoflavones to eat throughout their lives — in particular, one type of soybean isoflavone called genistein — had improved immunity against cancer. But rats that weren't given the isoflavone until after developing breast cancer didn't have that same immune response to kill cancer cells. Instead, these rats had higher rates of cancer growth and higher rates of recurrence after their tumors were removed. The study may explain why women in Asian countries, who tend to consume high amounts of soybean-based foods throughout their lifetime, have rates of breast cancer that are five times lower than those of women in the United States, the researchers said. The findings were published today (Feb. 1) in the journal Clinical Cancer Research. More than 200,000 U.S. women are diagnosed each year with breast cancer, and the majority have estrogen-receptor-positive breast cancer, according to the Centers for Disease Control and Prevention. One of the most common drugs to combat this type of cancer is tamoxifen, which acts to reduce estrogen's ability to promote cancer growth. In their animal study, the researchers induced cancer growth in rats that had a steady diet of genistein and in rats that never had any genistein until after the cancer developed. All of the rats were then treated with tamoxifen to kill the cancer. The researchers found that the rats raised on genistein had only a 7 percent chance of breast cancer recurrence after tamoxifen treatment, but the rats that were recently given genistein had a 33 percent recurrence rate. It's not clear why genistein would have this effect but it may be related to the body's immune system being activated by the isoflavone, recognizing it as a nutrient from its longtime consumption, said study senior author Leena Hilakivi-Clarke, a professor of oncology at the Georgetown Lombardi Comprehensive Care Center. "The immune system was not activated in animals that started consuming genistein for the first time with tamoxifen," Hilakivi-Clarke told Live Science. This may have resulted in the genistein appearing more like the cancer-fueling estrogen and less like a tumor-fighting agent, she said. In other words, the paradox is in the timing. It may be that soy consumption is protective only if started before cancer develops. Despite the lingering ambiguity of whether the same is true in humans, Hilakivi-Clarke thinks the animal study can inform doctors and their patients. "We have solved the puzzle of genistein and breast cancer in our rat model, which perfectly explains the paradox seen in earlier animal studies and patients," Hilakivi-Clarke said. "While many oncologists advise their patients not to take isoflavone supplements or consume soy foods, our findings suggest a more nuanced message — if these results hold true for women. Our results suggest that breast cancer patients [who ate soy before their diagnosis] should continue consuming soy foods after diagnosis, but not to start them if they have not consumed genistein previously." [6 Foods That May Affect Breast Cancer Risk] Maggie Neola, a staff dietitian for the Barnard Medical Center and Physicians Committee in Washington, who wasn't part of the study, said that findings from animal experiments often don't translate to humans and that she'd like to see research from population studies with women.
Coyle P.K.,Comprehensive Care
Neurologic Clinics | Year: 2012
Pregnancy is a major concern in multiple sclerosis (MS), because the typical patient is a young woman of childbearing age. This article reviews the impact of pregnancy on MS. Disease activity decreases, particularly during the last trimester. There is a temporary rebound of disease activity in the 3 months postpartum. Pregnancy and the postpartum period have many implications for counseling and for therapeutic decision making in MS. © 2012 Elsevier Inc.
Coyle P.K.,Comprehensive Care
The American journal of managed care | Year: 2010
Natalizumab is an alpha(4)-integrin antagonist, the first in its class for the treatment of multiple sclerosis (MS). Although multiple mechanisms have been proposed for the efficacy of natalizumab in MS, the most likely explanation is that it interferes with the migration of immune cells into the central nervous system. It does this by binding to the alpha(4) subunit of alpha(4)beta(1)-integrin and preventing leukocyte adhesion to endothelial vascular cell adhesion molecule-1. The efficacy of natalizumab in relapsing-remitting MS has been demonstrated in several double-blind, placebo-controlled trials. Natalizumab has been shown to slow the progression of disability in relapsing-remitting MS significantly better than placebo, and to reduce the number of new and enlarging T2 hyperintense and gadolinium-enhanced magnetic resonance imaging lesions. In a post hoc analysis, the proportion of patients with relapsing-remitting MS free of disease activity was significantly greater with natalizumab compared with placebo. Due to the rare risk of progressive multifocal leukoencephalopathy as a complication, natalizumab is primarily recommended in patients who fail, or cannot tolerate, treatment with interferon (IFN) beta or glatiramer acetate (GA). Stratification of those patients most likely to benefit from natalizumab treatment--such as those with highly active disease, severe disease, or extensive functional loss, or those who have failed or cannot tolerate IFN beta or GA therapy--would help define natalizumab's appropriate place in therapy.
MacMillan M.L.,Comprehensive Care |
Wagner J.E.,Comprehensive Care
British Journal of Haematology | Year: 2010
Allogeneic haematopoietic cell transplantation (HCT) remains the only treatment that can correct the haematological manifestations in patients with Fanconi anaemia. Over the last two decades, sequential changes to the approach to HCT have resulted in reduced regimen-related toxicity, superior engraftment and less graft-versus-host disease (GVHD), resulting in improved survival. The two pivotal changes that most influenced these improvements were the addition of fludarabine to the preparative regimen to augment engraftment, and the use of T cell depletion to reduce GVHD. With these improved HCT outcomes, indications for HCT are quite consistent regardless of donor source. Emphasis is now being placed on developing HCT regimens that will improve quality of life by reducing late effects, particularly the risk of malignancy, sterility and endocrinopathies. This paper will review the unique challenges of HCT in FA patients, with particular emphasis on the timing and approach to HCT. © 2010 Blackwell Publishing Ltd.
Coyle P.K.,Comprehensive Care
Expert Opinion on Biological Therapy | Year: 2014
Introduction: Alemtuzumab is a humanized IgG1 kappa monoclonal antibody approved for treatment of B-cell chronic lymphocytic leukemia. This cytolytic antibody is directed against CD52 and depletes lymphocytes, with monocytes, macrophages, natural killer cells and a subpopulation of granulocytes being affected to a much lesser degree. Alemtuzumab is currently under review to treat relapsing multiple sclerosis (MS) in the United States, based on positive Phase II and Phase III trials in both treatment-naïve and treated relapsing MS patients. There was excellent efficacy in suppressing both clinical and neuroimaging disease activities. In these trials, the comparator arm was not placebo, but high dose frequently dosed subcutaneous interferon beta 1a. Alemtuzumab has recently been approved by the European authorities for active relapsing MS, in essence as a first-line agent. It produces long-standing effects, consistent with an induction agent. Efficacy will have to be weighed against risk of adverse effects, which include autoimmune disorders and infection. Alemtuzumab joins an increasingly crowded market, and will add to the complexity of treating MS. Areas covered: This review will discuss alemtuzumab as a therapy for MS, reviewing PubMed for clinical trials, publications and presentations at international meetings. It will focus on a United States market perspective. Expert opinion: Alemtuzumab offers induction strategy for very active relapsing MS patients who have failed conventional therapy, and possibly selected treatment-naive patients. Alemtuzumab use is likely to be restricted to specialized MS centers, with long-term monitoring to determine the true risk for adverse effects. © 2014 Informa UK, Ltd.
Young L.B.,Comprehensive Care
Journal of Telemedicine and Telecare | Year: 2012
A literature review was conducted to identify research into multiple-contact (i.e. extended) telemedicine interventions for substance-use disorder. The goals were: (1) to describe the methodology used to evaluate telemedicine interventions; (2) to identify the range of interventions which have been formally evaluated; and (3) to summarize the findings. Fourteen databases and Google Scholar were searched, as well as bibliographies of relevant papers and online conference abstracts. There were 50 studies which met the inclusion criteria, of which 50% were randomized controlled trials. The studies most frequently reported the effect on substance use and 61% of those findings fully supported telemedicine interventions. Although the studies reported persistent challenges in sustaining participation, 76% of the studies reporting on satisfaction indicated that participants were enthusiastic supporters of telemedicine. Only 30% of reviewed studies addressed the effect on resource utilization. The majority of studies reported evidence of clinical effectiveness, which justifies continued research in the field.
News Article | February 22, 2017
Patients with multiple sclerosis had better problem solving ability and response time after training with a technology called transcranial direct current stimulation (tDCS), according to a new study published February 22, 2017 in Neuromodulation: Technology at the Neural Interface. During tDCS a low amplitude direct current is applied through electrodes placed on the scalp using a headset. The stimulation can change cortical excitability in the brain by making it easier for neurons to fire, which can help improve connections and speed up the learning that takes place during rehabilitation. Led by researchers at NYU Langone's Multiple Sclerosis Comprehensive Care Center, the new study reports that participants with MS who used tDCS while playing the cognitive training computer games designed to improve information processing abilities showed significantly greater gains in cognitive measures than those who played the computer games alone. Importantly, the participants completed the cognitive training and tDCS while at home. By enabling patients to be treated without repeat visits to the clinic, which can be a major challenge for people with MS as their disease progresses, the approach may improve quality of life for this patient population, according to the study's authors. "Our research adds evidence that tDCS, while done remotely under a supervised treatment protocol, may provide an exciting new treatment option for patients with multiple sclerosis who cannot get relief for some of their cognitive symptoms," says lead researcher Leigh E. Charvet, PhD, associate professor of neurology and director of research at NYU Langone's Multiple Sclerosis Comprehensive Care Center. "Many MS medications are aimed at preventing disease flares but those drugs do not help with daily symptom management, especially cognitive problems. We hope tDCS will fill this crucial gap and help improve quality of life for people with MS." MS is the most common progressive neurological disorder in working age adults, nearly 70 percent of whom will experience cognitive impairment with symptoms including slower information processing and difficulties with memory and problem solving. Other common symptoms of the disease include fatigue and mood, sensory and motor problems. In this study, the brain's dorsolateral pre-frontal cortex, an area linked to fatigue, depression and cognitive function, was targeted for tDCS. Twenty-five participants were provided with a tDCS system with a headset they learned to apply with guided help from the research team. In each session, a study technician would contact each participant through online video conferencing, giving him or her a code to enter into a keypad that commenced the tDCS session in order to control for dosing. Then, during the stimulation, the participant played a research version of computerized cognitive training games that challenged areas of information processing and attention and working memory systems. Members of the tDCS group participated in 10 sessions, and the researchers compared their results to 20 participants with MS who only played cognitive training games in their 10 sessions. Researchers found participants in the group treated with tDCS showed significantly greater improvements on sensitive, computer-based measures of complex attention and increases in their response times across trials compared to the group that did cognitive training games alone. Improvements were shown to increase over time with the number of sessions, which suggests the tDCS may have a cumulative benefit. But, more research is needed to determine how long these effects may last following culmination of sessions. The group that participated in tDCS plus cognitive training however did not show a statistically significant difference from the group that only played cognitive training games as measured by less sensitive standard neuropsychological measures like the Brief International Cognitive Assessment in MS (BICAMS) tests or on computer-based measures of basic attention. Those findings suggest the cognitive changes brought on by tDCS may require more treatment sessions to have noticeable improvements in daily functioning, according to Dr. Charvet. The researchers are recruiting for additional clinical trials involving 20 tDCS sessions and a randomized sham-controlled protocol, to look for additional evidence of benefits of tDCS. New research has also begun at NYU Langone to test tDCS for other neurological conditions, including Parkinson's disease. However, Dr. Charvet warns that some tDCS products on the market are sold straight to consumer without any clinical research behind them or information or guidance on dosing frequency, so it's important for anyone considering these technologies outside of a controlled research environment to consult with their physician. The device was designed in conjunction with inventor Marom Bikson, PhD, a professor of biomedical engineering at The City College of New York, and Abhishek Datta, PhD, the chief technology officer of Soterix Medical which holds a patent on the tDCS device. Dr. Charvet provided Bikson's team with feedback from participants enrolled in the trial to help better design the device. The study was funded by the National Multiple Sclerosis Society and The Lourie Foundation, Inc. In addition to Dr. Charvet and Dr. Bikson, the study authors include Lauren Krupp, Michael Shaw, Bryan Dobbs, Ariana Frontario, Kathleen Sherman, Abhishek Datta, Esmail Zeinapour and Margaret Kasschau.