FDA Approves Portable Nerve Stimulator for Use During Physical Therapy to Treat Walking Problems in People with MS
April 7, 2021
The U.S. Food and Drug Administration has approved a device that provides electrical pulses to the tongue for use along with physical therapy as a short-term treatment for mild to moderate walking (gait) problems in people with. The Portable Neuromodulation Stimulator (PoNSTM
Helius Medical Technologies, Inc.) generates electrical pulses to stimulate nerves in the tongue, and in turn the brain, to treat motor deficits.
The device is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program in people aged 22 and older. According to the company, the PoNS™ device will become commercially available in 2022.
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- Difficulty in walking -- also known as problems with gait -- is a common symptom experienced by people living with MS.
- The PoNS device is a non-implantable device that delivers mild electrical stimulation to the tongue, and is used during visits with a physical therapist. It consists of a controller and a mouthpiece that are connected to each other by a cord. The mouthpiece is held in place by the lips and teeth. The control unit is worn around the neck and sends electrical signals to the mouthpiece for approximately 20 minutes, connecting with nerves on the surface of the tongue to send impulses to the brain. These signals are then transmitted to muscles involved in walking. The therapist can connect the control unit to a computer, to provide information on areas for improvement.
- The FDA evaluated the safety and effectiveness of the PoNS device through two small clinical trials and based on data from “real world” use in rehabilitation settings. In one study, 20 people with MS and gait deficits used the PoNS device or a sham device that did not deliver stimulation. Gait measures improved significantly in the PoNS group, but not the control group. In the second study in 14 people with MS, the ability to maintain posture improved significantly in the PoNS group, but not in the sham group.
- People with oral health problems, other neurodegenerative diseases, chronic infectious diseases, unmanaged high blood pressure or diabetes, pacemakers, or who are pregnant should not use the device.