The US Food and Drug Administration (FDA) has approved the Portable Neuromodulation Stimulator (PoNS, Helius Medical Inc) for the short-term treatment of walking impairments as a result of mild to moderate symptoms from multiple sclerosis (MS).
PoNS is a prescription-only device intended to be used in combination with a supervised therapeutic exercise program in patients aged 22 years and older with MS.
“MS is one of the most common neurological diseases in young adults. [This] 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,” Christopher Loftus, MD, acting director, Office of Neurological and Physical Medicine Devices, FDA Center for Devices and Radiological Health, said in a news release.
PoNS is a neuromuscular tongue stimulator that generates electrical pulses that stimulate the trigeminal and facial nerves, sending neural impulses to the brain stem, which is thought to enhance neuroplasticity to address motor deficits.
The device’s controller and mouthpiece are connected to each other by a cord. The mouthpiece is held in place by the lips and teeth and the control unit is worn around the neck during a patient’s visit with a therapist.
In a randomized, controlled, double-blind trial involving 20 patients with MS-related gait deficits, 10 patients used the PoNS device and 10 used a sham control device that did not deliver stimulation.
Compared with the control group, the PoNS group achieved “statistically significant and clinically significant” improvement in their Dynamic Gait Index (DGI) score at the end of the study (14 weeks), the FDA said.
A separate study assessed the effects of the PoNS device (vs sham) with cognitive and physical rehabilitation in 14 patients with MS (7 in each group).
The PoNS group showed a statistically significant improvement over baseline in sensory organization tasks at 14 weeks, while analysis of DGI scores after 14 weeks showed no significant difference.
No serious safety adverse events were reported in clinical studies or separate real-world data provided by the company, the FDA said.
The PoNS device should not be used by patients with penetrating brain injuries, neurodegenerative diseases, oral health problems, chronic infectious diseases, unmanaged hypertension or diabetes, pacemakers, and/or a history of seizures, the FDA said.
“Because the PoNS device delivers electrical stimulation directly to the surface of the tongue, precautions for use are similar to those for transcutaneous electrical nerve stimulation,” the agency said.
Electrical stimulation should not be used in patients with an active or suspected malignant tumor; in areas of recent bleeding or open wounds; or in areas that lack normal sensation.
The PoNS device is not indicated in people younger than age 22 years or pregnant women, and those with a sensitivity to nickel, gold, or copper should also not use it.
The product had breakthrough device designation and was approved under the de novo premarket review pathway for new low- to moderate-risk devices.
It has also been approved by Health Canada to treat walking/gait deficits in patients with mild to moderate MS when used in combination with physical therapy over 14 weeks.
More information on the PoNS device is available online.