Helius Medical Technologies, Inc., a company dedicated to neurological wellness, recently announced that the multiple sclerosis (MS) pilot study assessing the company’s investigational Portable Neuromodulation Stimulator (PoNS™) device has met all of the study’s goals.

PoNS is a non-invasive device that allows the delivery of neurostimulation through the tongue. The device is based on the concept that the tongue can be used as a natural, direct entry to stimulate the brain, especially since it is richly innervated by thousands of nerve fibers and interconnected by two major cranial nerves to the brainstem.

The PoNS system is currently being evaluated in Canada, at the Montreal Neurological Institute and Hospital and Concordia University’s PERFORM Center, as a therapy for gait and balance disorder in patients with MS. In total, 14 participants (7 with active MS and 7 control individuals) were submitted to this non-invasive brain stimulation technology along with physiotherapy. The potential clinical benefits of PoNS neurostimulation were evaluated and functional magnetic resonance imaging (fMRI) was employed to determine the device’s effect while participants performed working memory and mental imagery tasks, with or without stimulation.

fMRI results revealed that the PoNS device seems to facilitate neural plasticity. In fact, after treatment, patients with active MS exhibited a brain function similar to healthy individuals. MS patients also experienced a significant improvement in balance after 14 weeks of treatment. Furthermore, researchers reported a good safety profile for PoNS therapy.

“The researchers from the Montreal Neurological Institute and Hospital are pleased with the execution of this study and are excited by the results as they point to a new frontier in research in brain injury rehabilitation. We are happy to be on the forefront of research that may bring this technology to patients in need,” said the study’s Principal Investigator, Dr. Gabriel Leonard, in a press release.

“We are delighted with the findings that are consistent with prior studies. The fMRI data show that the PoNS may be changing the way the brain functions,” added Helius’ Chief Medical Officer, Dr. Jonathan Sackier. “Measuring brain activity and the changes taking place through fMRI is designed to determine in an objective way if, in fact, there are indications of neuroplastic change in the brain.”

This pilot study also allowed the research team to identify factors that need to be improved in the design of future trials, including recruitment, screening, randomization and execution. The authors determined that a sample size of 128 participants (64 with active MS and 64 controls) would be appropriate for a definitive MS clinical trial 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 PoNS as a potential therapeutic tool,” said Helius’ CEO, Philippe Deschamps. “We reached all the objectives of this study and are optimistic as we continue to advance the PoNS device through clinical trials.”

The results of the study will be submitted for publication in the near future.

In the United States, the PoNS device is currently being tested for the treatment of balance disorder in patients with mild to moderate traumatic brain injury. Helius plans to file the device for U.S. Food and Drug Administration clearance.