NEWTOWN, Pa.--Helius Medical Technologies (“Helius”, “HMT”, or the “Company”) announced that it has achieved full enrollment for its Multiple Sclerosis pilot clinical trial at the Montreal Neurological Institute. The trial, “Examining the efficacy of non-invasive neuromodulation in reducing symptoms of Multiple Sclerosis,” launched in February 2015, is a 14-subject, blinded feasibility study investigating Helius’ Portable Neuromodulation Stimulator (PoNS™) and physiotherapy protocol on the rehabilitation of balance and gait symptoms in subjects with Multiple Sclerosis.
“Non-invasive neuromodulation to improve gait in chronic multiple sclerosis: a randomized double blind controlled pilot trial”
Subjects enrolled in the study receive treatment with the PoNS device and concomitant physiotherapy designed to improve both balance and gait. The primary endpoint, at 14-weeks, is improvement in gait as quantified by the DGI (Dynamic Gait Index) and improvement in balance as measured by the Sensory Organization Test (SOT). The study, including data analysis, is expected to conclude in Q4 2015.
“Achieving full enrollment of this study within our forecasted timeline is a significant milestone for Helius and our research into Multiple Sclerosis,” said Helius’ CEO, Philippe Deschamps. “This pilot protocol is primarily designed to be an external validation of a previously published, internally managed study of similar design*. In addition, the results of this study will help inform the design of a larger, efficacy focused, registrational MS protocol anticipated to begin by the end of the year.”
“We are proud of the significant progress that has been made in the clinical development and validation of this protocol. We are pleased with the smooth execution of the trial and we are looking forward to the data analyses, which we hope will reflect the hard work of both the clinical team and the subjects,” added Dr. Gabriel Leonard, Principal Investigator of the study.
* “Non-invasive neuromodulation to improve gait in chronic multiple sclerosis: a randomized double blind controlled pilot trial”: Journal of NeuroEngineering and Rehabilitation 2014, 11:79
About the PoNS
The Portable Neuromodulation Stimulator (PoNS) device is an investigational medical device being studied for the treatment of neurological symptoms caused by disease or trauma as part of a physical therapy program. The PoNS is currently being studied in the United States for the treatment of balance disorder for subjects with mild to moderate Traumatic Brain Injury (mTBI), and in Canada for the treatment of gait and balance disorder for subjects with Multiple Sclerosis (MS).
The PoNS™ device is believed to be the first non-invasive means for delivering neurostimulation through the tongue. Researchers believe that use of the tongue as a gateway to the brain may be one of the most natural, non-invasive and direct ways to stimulate the brain. The tongue is anatomically unique, being richly innervated by thousands of nerve fibers and interconnected to the brainstem by two major cranial nerves.
About Helius Medical Technologies (HMT)
Helius Medical Technologies is a medical technology company focused on neurological wellness. HMT seeks to use unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. HMT intends to file for U.S. Food and Drug Administration clearance for the PoNS™ device. For more information, please visit www.heliusmedical.com.
About the Montreal Neurological Institute
The Montreal Neurological Institute and Hospital – (“The Neuro”) is a world-leading destination for brain research and advanced patient care. Since its founding in 1934 by renowned neurosurgeon Dr. Wilder Penfield, The Neuro has grown to be the largest specialized neuroscience research and clinical center in Canada, and one of the largest in the world. The seamless integration of research, patient care, and training of the world’s top minds make The Neuro uniquely positioned to have a significant impact on the understanding and treatment of nervous system disorders. The Montreal Neurological Institute is a McGill University research and teaching institute. The Montreal Neurological Hospital is part of the Neuroscience Mission of the McGill University Health Centre.
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Helius Medical Technologies
Phil Deschamps, 614-596-2597
Becky Kern, 914-772-2310
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