In March, the FDA approved marketing of the Portable Neuromodulation Stimulator device — a medical device intended to supplement physical therapy for those 22 and older with MS and walking (gait) difficulties. The PoNS device is now slated to hit U.S. markets early next year, developer Helius Medical Technologies announced in a recent financial report.
The PoNS device is placed on the tongue and attaches to a controller worn around the neck. Delivering translingual (through the tongue) electrical impulses, the PoNS uses a form of external brain stimulation to induce neuroplasticity — the brain’s ability to relearn and “rewire” itself in response to new stimuli and experiences. This stimulation targets the brain stem, which is responsible for movement and sensory perception (among other functions).
The PoNS device received the FDA’s Breakthrough Device designation after being granted approval based on two clinical trials. In the first trial, 20 individuals with MS and gait difficulties underwent an exercise regimen. Those who were randomly assigned to use the PoNS device as an add-on showed clinically and statistically significant improvements in their Dynamic Gait Index (DGI, which assesses walking ability based on a person’s balance and likelihood of falling) compared to those who received a sham device.
The second study found that those who used the PoNS device alongside cognitive and physical rehabilitation showed improved scores in sensory organization tasks (SOT) compared to the sham group.
“Today’s authorization offers a valuable new aid in physical therapy and increases the value of additional therapies for those who live with MS on a daily basis,” stated Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health, of the device’s approval.