Medical technology firm Helius Medical Technologies has completed enrollment of patients for its multiple sclerosis (MS) pilot clinical trial at the Montreal Neurological Institute.
The study "examining the efficacy of non-invasive neuromodulation in reducing symptoms of multiple sclerosis," was launched in February 2015.
The trial is a 14-subject and blinded feasibility study, which is investigating Helius’ Portable Neuromodulation Stimulator (PoNS) and physiotherapy protocol on the rehabilitation of balance and gait symptoms in subjects with MS.
Helius’ PoNS is an investigational medical device that is being studied to treat neurological symptoms caused by disease or trauma as part of a physical therapy programme.
It is currently being studied to treat balance disorder in subjects with mild to moderate traumatic brain injury (mTBI) in the US and for the treatment of gait and balance disorder in subjects with MS in Canada.
Helius Medical Technologies CEO Philippe Deschamps said: "Achieving full enrollment of this study within our forecasted timeline is a significant milestone for Helius and our research into multiple sclerosis."
According to the company, subjects enrolled in the study receive treatment with the PoNS device and concomitant physiotherapy designed to improve both balance and gait.
The primary endpoint of the study is improvement in gait as quantified by the DGI (dynamic gait index) and improvement in balance as measured by the sensory organization test (SOT).
Helius plans to complete the study, along with data analysis, by the fourth quarter of this year.