NEWTOWN, Pa.--(BUSINESS WIRE)--Helius Medical Technologies (“Helius”, or the “Company”) announced the enrollment of the first three subjects in the Multiple Sclerosis (“MS”) feasibility study at the Montreal Neurological Institute and Hospital and Concordia’s PERFORM Center. The trial, “Examining the efficacy of Non-invasive Neuromodulation in reducing symptoms of Multiple Sclerosis“, is a double-blind, sham-controlled study of the safety and efficacy of Helius’ Portable Neuromodulation Stimulator (PoNS™) device, an investigational medical device that is designed to induce neuromodulation by stimulating the cranial nerves found in the tongue. A total of 14 subjects will receive treatment with the non-invasive brain stimulation 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 Dynamic Gait Index (DGI), Sensory Organization Test (SOT) and Functional Magnetic Resonance imaging (fMRI). The study is expected to conclude this summer.
“We are very pleased to begin this trial as the design is the basis of the registrational MS study scheduled to initiate later in the year,” said Helius’ CEO, Philippe Deschamps.
“The Montreal Neurological Institute and Hospital is excited to be leading the effort in this research. We are proud to be at the forefront of testing new technologies for the treatment of neurological symptoms,” said Dr. Gabriel Leonard, Principal Investigator for the study. Dr. Yves Lapierre and Dr. Alain Ptito from the Montreal Neurological Institute and Hospital join Dr. Leonard as investigators in the study.
About the PoNS™
The PoNS™ device is an investigational medical device being studied for the treatment of neurological symptoms caused by disease or trauma. 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 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 inervated by thousands of nerve fibers and interconnected to the brainstem by two major cranial nerves.
Study Participation:
To learn more about this trial or recruitment opportunities please contact:
Marcel Mazaltarim M.Sc.@ mmazal@neuromtl.com or 1-866-331-3431.
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 centre 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.
About PERFORM Centre
PERFORM is a research centre, based in the Montreal community, with a distinctly Concordia approach to healthy lifestyle management. It represents a significant and forward-thinking investment by the Quebec and Canadian governments as well as Concordia University in addressing the broader determinants of health.
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