The US FDA has approved the Portable Neuromodulation Stimulator 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.
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.
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.
Source: FDA