Helius Medical Technologies, a medical technology company focused on the treatment of neurological symptoms caused by disease or trauma, announced that the Multiple Sclerosis (MS) pilot study evaluating its investigational Portable Neuromodulation Stimulator (PoNS™) device, met all of its study objectives.
A total of 14 subjects (7-active and 7-sham control) received treatment with the non-invasive brain stimulation technology and concomitant physiotherapy. The independent trial took place at the Montreal Neurological Institute and Hospital and Concordia University’s PERFORM Center.
The study objectives were to explore the potential beneficial effects of PoNS stimulation, as previously reported, and to provide data to be used for the design of future studies to support requests for marketing authorization.
The study included the first use of Functional MRI ("fMRI") to measure the effect of PoNSTM while performing tasks with, and without, stimulation.
Study result highlights:
fMRI measured the effect of PoNSTM neurostimulation while performing working memory and mental imagery tasks. Results suggest that the PoNSTM device may be facilitating neural plasticity.
fMRI results were significantly different between the Active Group (who manifested brain function comparable to healthy subjects following treatment) and the control group. (p<0.02).
The PoNS stimulation group showed a statistically significant improvement (p<.001 in balance as measured by the Sensory Organization Test (SOT) scores, which were compared at baseline and week 14. The change in the control group did not reach the same level of statistical significance (p >.05).
There was a good safety profile for the PoNSTM device reported in the study.
Factors to improve recruitment, screening, randomization and execution were identified and will be considered in the design of future MS studies. The results included a power analysis suggesting a sample size of 128 subjects (64 active, 64-sham) would be suitable for a definitive MS study.
"This is an exciting and promising development for our company, patients and the healthcare community. Addressing symptoms caused by MS has been a challenge for the medical community and we are excited to pursue PoNSTM as a potential therapeutic tool", said Helius’ CEO, Philippe Deschamps.
Helius would like to thank the study investigators Doctors Leonard, Ptito, and Lapierre, as well as study staff, subjects and founding scientists. The investigators and sponsor intend to submit study results for publication.
The PoNS™ device is a non-invasive means for delivering neurostimulation through the tongue. The PoNS™ therapy 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.