NCT05437276Completed
A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People With Multiple Sclerosis (MS)
A Therapeutic Experience Program (TEP) Study Assessing Adherence to On-Label PoNS® Therapy for Improvement of Gait in People With Multiple Sclerosis (MS) in a Real-World Clinical Setting
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
PoNS therapy is a rehabilitation program that uses the PoNS device in conjunction with individualized physical exercise. This is an outcome research open label observational interventional multi-center study investigating the relationship between subject's adherence to PoNS therapy and therapeutic outcomes.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 43 (actual)
- First submitted
- 17 Jun 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Helius Medical Inc
- Diseases
- Multiple sclerosis
- NCT number
- NCT05437276
What you commit to
- Study type: Observational
- Participants enrolled: 43
- From 1 Jul 2022 to the primary completion date, 30 Jun 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who are currently attending physical rehabilitation and are unwilling to switch to PoNS-specific physical therapy regimen.
Other illness
- Dementia.
- Subjects will also be excluded as per the Helius Medical PoNS device indication for usage ("electrical stimulation should not be used: if there is an active or suspected malignant tumor; in areas of recent bleeding or open wounds; in areas that lack normal sensation; in women who are pregnant, or in people with sensitivity to nickel, gold or copper").
Other
- Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
- Subjects who are already functional community ambulators (gait speed\>120cm/s43).
Who the study is looking for
- Men and women ≥ 22 years of age with a diagnosis of MS.
- EDSS scores \< 6.5 at screening; a demonstrated gait deficit.
- Can walk at least 10 meters with or without the use of walking aids.
- Participants must be stable without relapse for at least 60 days and agree to PoNS therapy regimen.
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shepherd Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| MGH Institute of Health Professions Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Neurology Center of New England P.C. Coordinator of this site? Confirm its status | Foxborough | United States | Unknown status |
| NYU Langone Health, NYU Grossman School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oregon Health and Science university (OHSU) Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.