PoNS Device

The Portable Neuromodulation Stimulator, or PoNS, is a non-invasive medical device developed and marketed by Helius Medical Technologies for the treatment of walking difficulties associated with multiple sclerosis (MS).

The PoNS device, in combination with supervised therapeutic exercise programs, was approved in the U.S. in March 2021 as a short-term treatment for MS-related walking problems in patients ages 22 and older.

In Canada, the device has been available since March 2020, for use on a short-term basis (14-week treatment) for patients with mild and moderate MS symptoms and in combination with physical therapy.

PoNS is currently under regulatory review for market authorization in Australia.

How PoNS works

The device, containing more than 100 gold-plated electrodes, is placed on top of the tongue, and connected, via a cord, to a controller that is worn around the neck. It works by sending mild electrical signals to the brain through two major cranial nerves that innervate — or supply nerves to — the tongue: the trigeminal and the facial nerves.

The trigeminal nerve is responsible for biting, chewing, and swallowing, as well as face sensations, while the facial nerve controls most of the muscles involved in facial expression. These nerves directly connect with the brainstem — a control center for functions such as sensory perception and movement — which in turn communicates with other parts of the brain.

By sending electrical impulses to the brainstem, PoNS is thought to promote a natural flow of stimuli throughout the brain that promote neuroplasticity — the brain’s ability to adapt or rewire itself in response to new experiences.

The device, when combined with targeted physical training, is expected to promote both the development and strengthening of neuronal circuits related to a given task, retraining mind-body connections and boosting the benefits of rehabilitation in MS patients.

Notably, the electrical impulses produced by PoNS to the tongue are not harmful and may be perceived by the patient as a “buzzing” or “champagne bubble” sensation, according to the device’s developer.

PoNS in clinical trials

The safety and effectiveness of PoNS, in combination with targeted physical therapy, were assessed in two clinical trials. Those trials investigated the device for its ability to lessen walking difficulties in MS patients.

The first study (NCT04498039), sponsored by the University of Wisconsin, recruited 20 adults with MS-related gait problems who were still able to walk 20 minutes on a treadmill without rest.

The participants were randomly assigned to use either PoNS or a sham device — providing very low, non-perceivable stimulation — during training sessions over a 14-week intense exercise program that included gait, balance, and relaxation training.

The program consisted of two weeks of twice-daily sessions in the laboratory, followed by 12 weeks (about three months) of the same daily routine at home.

The results showed that patients using PoNS experienced a statistically and clinically significant improvement in walking skills — as assessed with the Dynamic Gait Index (DGI) — after six weeks, which was sustained through 14 weeks. No such gains were observed in the sham group.

A second trial (NCT04496531), sponsored by Helius, had a similar design, with 14 adult MS patients using either PoNS or a sham device while undergoing intensive physical and cognitive training for 14 weeks, or about 3.5 months.

The physical program, conducted in the lab for the first two weeks and at home thereafter, included twice-daily balance, gait, motor control, and breathing and awareness training, with an extra session of breathing and awareness before bedtime. Cognitive and working memory training was completed four times a week for 10 weeks.

At the end of the study, five of the seven participants assigned to the sham group chose to subsequently complete the training program with PoNS (rollover group).

Data demonstrated that the PoNS group, but not the sham group, showed statistically significant improvements in balance — as assessed with the sensory organization task — after 14 weeks. Patients in the rollover group also exhibited steady balance gains with the PoNS-training combined intervention.

Compared with the sham device, PoNS also was associated with a trend of greater improvement in DGI scores and in cognitive function, although the group differences did not reach statistical significance.

Moreover, brain imaging during walking and cognitive tasks showed that brain regions linked to such functions were significantly activated only among patients who received the electrical stimulation. The sham group showed a different pattern of motor region activation and no greater activation of cognitive regions.

PoNS was generally well-tolerated in both trials, with no reports of serious adverse events.

Other information

In the U.S., the device is not recommended for pregnant women and individuals younger than 22, as it has not been tested in these patient groups.

Also, PoNS should not be used by people with certain health conditions, including penetrating brain injuries, oral health problems and tumors, other neurodegenerative diseases, chronic infections, unmanaged high blood pressure or diabetes, and those using pacemakers or with a history of seizures. People who are sensitive to certain metals (specifically nickel, gold, or copper) should not use the device. 

 

Last updated: Oct. 11, 2021

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Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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