US-based Helius Medical Technologies has enrolled the first three subjects in the Multiple Sclerosis (MS) feasibility trial of its Portable Neuromodulation Stimulator (PoNS) device at the Montreal Neurological Institute and Hospital, and Concordia University's PERFORM Center in Canada.
The PoNS device is being studied to treat neurological symptoms caused by disease or trauma.
The double-blind, sham-controlled trial will evaluate safety and efficacy of the PoNS device, which is designed to induce neuromodulation by stimulating the cranial nerves found in the tongue.
The trial will enrol a total of 14 subjects, and they will receive treatment with the non-invasive brain stimulation device and concomitant physiotherapy, designed to improve both balance and gait.
Primary endpoint of the trial, at 14-weeks, is improvement in gait as quantified by the Dynamic Gait Index (DGI), sensory organisation test (SOT) and functional magnetic resonance imaging (fMRI).
Helius CEO Philippe Deschamps said: "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."
According to the company, the trial entitled "Examining the efficacy of non-invasive neuromodulation in reducing symptoms of multiple sclerosis" is expected to be completed by this summer.
Principal investigator for the trial Dr Gabriel Leonard said: "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."
Dr Leonard has been joined by Dr Yves Lapierre and Dr Alain Ptito from the Montreal Neurological Institute and Hospital as investigators in the trial.
The PoNS device is currently being studied in the US to treat balance disorder for subjects with mild to moderate traumatic brain injury (mTBI), and in Canada to treat gait and balance disorder for subjects with MS.
The company said the PoNS device is believed to be the first non-invasive means for delivering neurostimulation through the tongue.
According to researchers, 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.