Translingual Neuromodulator to Assist Ambulation in Multiple Sclerosis Now Available in US 

Helius Medical Technologies (Newtown, PA) has announced that their translingual neuromodulation (portable neuromodulation stimulator [PONS]) device,  shown to assist walking in people with multiple sclerosis (MS), is now available in the US. The PONS device is a portable, nonimplant neuromodulator to be used adjunctively with therapeutic exercise. 

In the TBI-001 trial (NCT01847755) of the device, 67.2% of participants with chronic balance impairment, had a statistically significant improvement in balance as measured by mean Sensory Organizational Test (SOT) scores at 2 and 5 weeks compared with baseline. Mean Dynamic Gait Index (DGI) scores were also significantly increased from baseline at weeks 2 and 5.

The translingual modulator includes a controller worn around the neck and a mouthpiece that rests under the tongue tip to deliver mild electric impulses to the tongue and cranial nerves. Using the device with physical activity provides results in consolidated neuroplastic changes and therapeutic functional outcomes, improving gait deficit in MS patients. 

“We believe that we are unlocking the full potential of neuromodulation and neuroplasticity to help MS patients walk more steadily and safely,” said Antonella Favit-Van Pelt, MD, PhD, chief medical officer, Helius. “Approximately 40% of individuals with MS will need walking assistance within 15 years of the onset of the disease. PoNS therapy provides a unique opportunity for these patients to improve gait functionality and mobility.” 

The device is approved for marketing by the Food and Drug Administration for uses with an exercise therapy program in people, age 22 years or more, with mild-to-moderate MS symptoms resulting in gait deficits.