The FDA approved a portable, non-implantable device in conjunction with supervised therapeutic exercise for short-term treatment of gait deficit in patients ages 22 years and older with mild to moderate multiple sclerosis (MS) symptoms.
The Portable Neuromodulation Stimulator (PoNS) is a neuromuscular tongue stimulator consisting of a controller and a mouthpiece connected to each other by a cord that delivers “mild neuromuscular electrical stimulation to the dorsal surface of the patient’s tongue,” the FDA explained. The device stimulates the trigeminal and facial nerves to assist in the treatment of motor deficits and allows the therapist to review usage data and identify “potential areas of missed or shortened [therapy] sessions.”
“MS is one of the most common neurological diseases in young adults. 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,” Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.
This approval was based two clinical studies — the first trial involved 20 patients with MS-related gait deficits who were randomized 1:1 to the PoNS device or a sham device. The primary outcome was the Dynamic Gait Index (DGI), which was assessed at baseline, two weeks, six weeks, 10 weeks, and 14 weeks. “The results showed that the PoNS group on average achieved improvement in their DGI score of 7.95 at the end of the study, which was statistically significant and clinically significant, while the control group did not,” the FDA wrote.
In the second study, “the clinicians investigated the effects of the PoNS device with cognitive rehab and physical rehab in 14 patients with MS, who did not know whether they had the PoNS device or the sham control device, in a randomized controlled trial where seven patients used the PoNS device and the other seven used a sham device,” the agency wrote. “Baseline evaluations included sensory organization tasks (SOT) and DGI scores. The PoNS device group showed a statistically significant improvement in SOT scores at 14 weeks compared to the baseline value. Analysis of DGI scores after 14 weeks showed no significant result.”
The device manufacturer also provided the FDA with data from a retrospective analysis of real-world data on MS patients using the PoNS device in a clinical rehabilitation setting. And, the agency added, there were no serious adverse events in the clinical trials or the retrospective analysis.
“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 warned. “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. Electrical stimulation should not be used if there is an active or suspected malignant tumor; in areas of recent bleeding or open wounds; or in areas that lack normal sensation. The PoNS device has not been tested on, and thus should not be used by, individuals under the age of 22 or who are pregnant. The PoNS device should not be used if a patient is sensitive to nickel, gold, or copper.”
The PoNS device is manufactured by Helius Medical, Inc.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 36
Topic ID: 82,36,730,36,192,725,925