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.
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