The American Food & Drug Administration has approved a new device for treating gait deficits in multiple sclerosis (MS) patients.
The Portable Neuromodulation Stimulator (PoNS), generates electrical pulses on the tongue to stimulate trigeminal and facial nerves to treat motor deficits. The FDA said that for it to be available by prescription, must be part of a supervised therapeutic exercise program in MS patients 22 and older. The device was authorised through the FDA’s ‘de novo’ premarket review pathway for new devices which pose do not pose significant risks of adverse effects.
In a statement, Christopher Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said: “MS is one of the most common neurological diseases in young adults. Today’s authorisation 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.”
Onset of MS symptoms, which can include difficulties with walking and balance, typically occurs between 20 and 40, with greater frequency in women.
The PoNS device electrical stimulates the dorsal surface of the patient’s tongue. A control unit is worn around the neck which sends signals to a mouthpiece which the patient keeps in place with lips and teeth. Later, usage data can be viewed by a therapist to spot “potential areas of missed or shortened sessions,” the FDA noted.
The FDA gave their approval based on two clinical studies. One involved 20 MS patients with gait deficits (half with PoNS; half with a sham device). Th FDA said that the PoNS group showed “statistically significant and clinically significant” improvement in Dynamic Gait Index (DGI) scores at 14 weeks not seen in the sham device group.
The other study, with 14 patients, showed improvements from baseline in sensory organisation task scores (but not in DGI scores) at 14 weeks. There were no serious safety or adverse effects reported.
Among the FDA’s cautions, the FDA stated that 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, or a history of seizures.
Source: MedPage Today
