PoNS Device Improves Walking Skills Early-on, New Data Show
Using the portable neuromodulation stimulator (PoNS) device during a targeted exercise program significantly improves walking skills in people with multiple sclerosis (MS), according to recent real-word data.
Notably, significant improvements were observed from the second week onward, and more than half of the 42 patients patients experienced clinically meaningful gains at the end of the 3.5-month intervention.
These findings add to data from previous PoNS clinical trials, further supporting the device’s potential to ease walking problems commonly experienced by MS patients.
The results were presented in the poster, “Translingual Neurostimulation by Portable Neuromodulation Stimulator System as a New Rehabilitation Therapy for Improving Gait in People With Multiple Sclerosis,” at the 2022 Consortium of Multiple Sclerosis Centers Annual Meeting, held in Maryland, June 1–4.
The poster was one of 10 rehabilitation research presentations nominated for the Labe C. Scheinberg Award, which recognizes the platform or poster with the greatest impact in advancing MS care.
“We are delighted to share the benefits of our innovative PoNS device and to be part of the community that is working to bring cutting edge interventions to improve gait deficits in patients with MS,” Antonella Favit-VanPelt, MD, PhD, chief medical officer of Helius Medical Technologies, the therapy’s developer, said in a press release.
“It is especially gratifying that our poster was selected out of 150 to receive a prestigious award nomination,” Favit-VanPelt added.
PoNS is an innovative, non-invasive portable device consisting of a mouthpiece that is connected via a cord to a controller worn around the neck. When placed on the tongue, the mouthpiece delivers a light electrical stimulation to two nerves that innervate the tongue and connect with a brain region that works as a motor control center.
This stimulation, 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 increasing rehabilitation’s benefits in MS patients.
This is based on a natural phenomenon called neuroplasticity, in which the brain adapts and rewires in response to new experiences.
In the U.S., PoNS is approved, in combination with supervised therapeutic exercise programs, as a short-term treatment for mild-to-moderate MS-associated gait issues in patients 22 and older. The device also is available in Canada and Australia for similar indications.
Regulatory approvals were based on positive data from two clinical trial trials (NCT04498039; NCT04496531) that involved 34 adults with MS-related walking problems. Results showed that 14 weeks of combined intervention with PoNS, plus an exercise program, significantly improved patients’ walking skills and balance over using a sham device plus exercise.
Newly presented data concerned real-world findings from 42 MS patients (28 women and 14 men) who underwent the PoNS therapy rehabilitation program in four Canadian rehabilitation clinics from March to December 2019.
The program, conducted in the lab for the first two weeks and at home thereafter, included once-a-day warm-up and motor control sessions without PoNS, and twice-daily balance, gait, and breathing and awareness training using the device.
Patients’ mean age was 55.4 years and they had been living with the disease for a mean of 18.6 years (73.8% with a disease duration superior to 10 years. More than 90% had moderate-to-severe disability, as assessed with the Expanded Disability Status Scale (EDSS).
Walking skills were assessed with the 10-item Functional Gait Assessment (FGA) scale, with scores ranging from 0–30 and lower scores indicating greater impairment.
Results showed that PoNS significantly improved walking at all follow-up time points — starting from week 2 and up to week 14 — with a mean increase of 4.75 points in the FGA score at the end of the program.
Notably, 58.3% of patients showed an FGA improvement of 4 or more points, which is greater than the minimum detectable change and minimum clinically important difference determined for older adults and people with other neurological diseases.
Patients with more severe disability showed smaller FGA gains than less-disabled patients (mean of 2.33 vs. 5.75 points), but differences between study start and the end of the intervention were statistically significant for both groups.
In addition, a pooled analysis of real-word and clinical trial data resulted in similar findings.
Specifically, the intervention was associated with a 4.58-point increase in an adjusted 7-item Dynamic Gait Index (DGI) and 55% of the 53 patients who completed 14-week assessments experienced a 4-point or greater increase in the adjusted DGI since study start. DGI is an eight-item gait measure that was used in PoNS trials and that shares seven tasks with FGA.
Combined findings also supported the device’s favorable safety profile, with only minimal adverse side effects being reported, and no serious adverse event being deemed related to the intervention.
“This latest dataset provides key real-world evidence of our therapy’s clinical benefits, which can be seen at two weeks from beginning rehabilitation treatment with PoNS.” Favit-VanPelt said. “We look forward to continuing to gather real-world evidence through our Therapeutic Experience Program (TEP) [and] the recently announced Patient Therapy Access Program.”
TEP is meant for Helius to partner with neurologists and neurorehabilitation therapists at 10 to 12 U.S. centers of excellence who express an interest in becoming early adopters of PoNS. PTAP, expected to run through Dec. 31, is designed to provide MS patients in the U.S. access to the device at a greatly reduced price.
PTAP’s participants also will be invited to join the company’s upcoming registry program, which will collect important health economic information to establish PoNS’ value on key therapeutic outcomes and will complement the data gathered through TEP.