09.03.15
Helius Medical Technologies has achieved full enrollment for its Multiple Sclerosis pilot clinical trial at the Montreal Neurological Institute in Canada.
The trial, launched in February, 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 (MS).
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 the fourth quarter of this year.
“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.”
The Portable Neuromodulation Stimulator 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 currently is 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.
“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,” said Gabriel Leonard, M.D., principal investigator of the study.
The PoNS device is believed to be the first non-invasive means for delivering neurostimulation through the tongue, Helius Medical executives claim. 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.
Based in Newtown, Pa., Helius Medical Technologies is a medical technology holding company that develops, licenses and acquires non-invasive treatments disease- or trauma-related neurological disorders.
The trial, launched in February, 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 (MS).
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 the fourth quarter of this year.
“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.”
The Portable Neuromodulation Stimulator 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 currently is 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.
“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,” said Gabriel Leonard, M.D., principal investigator of the study.
The PoNS device is believed to be the first non-invasive means for delivering neurostimulation through the tongue, Helius Medical executives claim. 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.
Based in Newtown, Pa., Helius Medical Technologies is a medical technology holding company that develops, licenses and acquires non-invasive treatments disease- or trauma-related neurological disorders.