PoNS device leads to long-term gait improvements: Real-world study
Patients who adhered to regimen at home saw greater functional gains
A 14-week regimen of physical therapy combined with PoNS — a neurostimulator device used to improve mobility — led to significant gait improvements in people with multiple sclerosis (MS), with evidence that its benefits are sustained over time, according to new data from the real-world PoNSTEP clinical study.
Consistent with earlier data, results from the now-completed study indicated patients who more strictly adhered to the therapeutic regimen during the study’s at-home portion saw greater functional gains.
“We are pleased to report the PoNSTEP study results corroborate the known evidence of PoNS Therapy’s efficacy in improving gait deficit due to MS,” Dane Andreeff, president and CEO of Helius Medical Technologies, the developer of PoNS, said in a company press release. “We look forward to sharing the data to increase awareness on PoNS Therapy at upcoming scientific conferences.”
PoNS is a neurostimulator device intended to improve walking and balance in people with mild or moderate MS. It works by delivering light electrical pulses to the tongue, which are transmitted to the brain via two cranial nerves.
Believed to promote neuroplasticity
This stimulation is believed to promote neuroplasticity, or the brain’s ability to rewire in response to new experiences. When used along with physical therapy, PoNS is expected to help strengthen neuronal circuits related to specific tasks, thereby enhancing the benefits of rehabilitation.
It’s approved in the U.S. for patients 22 and older, to be used short term in combination with supervised physical rehabilitation programs.
The prescribed regimen involves using the PoNS device for 100-120 minutes (1.5-2 hours) daily for 14 weeks (a little over three months). While accumulating evidence has demonstrated the device’s ability to improve walking abilities for MS patients, it’s possible that poor adherence to the regimen during real-world use could curb its therapeutic benefits.
“Like many therapeutics, treatment compliance is key to achieving incremental and lasting therapeutic beneficial effects with PoNS Therapy,” Andreeff noted.
Helius launched the PoNSTEP study (NCT05437276) to investigate how treatment adherence would influence gait improvements for patients using PoNS in a real-world setting.
The study enrolled 41 people with mild-to-moderate MS and walking difficulties who started a 14-week regimen of PoNS along with physical rehabilitation. This included two weeks of in-clinic treatment supervised by a physical therapist, followed by 12 weeks of unsupervised at-home therapy. Participants were then followed for six months in a post-treatment observation period.
The study’s main goal was to evaluate changes in dynamic gait index (DGI), which assesses a person’s ability to maintain balance during various physical tasks. Patients who experienced at least a 30% decline in DGI performance after the six-month observation period were eligible for an additional 12 weeks of therapy.
Significant improvement in dynamic gait index at week 14
Results indicated a statistically significant improvement in DGI at week 14 among the 38 participants who completed the treatment protocol, according to Helius. Specifically, the mean DGI improved by 5 points over the treatment period.
During the in-clinic part of the regimen, adherence to the treatment regimen was 89.5%, and there was a mean 2.5-point improvement in DGI over those two weeks.
In the at-home part, average therapy adherence was 71%, and gait improvements during this phase correlated with adherence to the treatment regimen. Patients who had at least 85% adherence to the regimen exhibited a significantly greater mean improvement in DGI scores than those with less than 85% adherence (3.7 vs. 2 points).
Among 28 patients who completed treatment and were reassessed after the six-month observation period, one person experienced a 30% or greater decline in DGI. The mean DGI decline across all participants was 4.1.
Helius indicated these findings support the long-term benefits of PoNS therapy, and are in line with data from clinical trials involving people with balance issues due to traumatic brain injury.
“The results from this study validate existing evidence of the efficacy of PoNS across clinical data and real-world utilization of the therapy by demonstrating durability of effect as further evidence of its long-term therapeutic benefits,” said Antonella Favit-Van Pelt, MD, PhD, chief medical officer of Helius.
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