A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People With Multiple Sclerosis (MS)
Completed
Conditions studied: Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)
In brief
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.
Key facts
- Study ID
- NCT05437276
- Run by
- Helius Medical Inc
- People needed
- 43
- Starts
- 2022-07-01
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2025-03-28
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
- Dementia.
- Subjects who are currently attending physical rehabilitation and are unwilling to switch to PoNS-specific physical therapy regimen.
- Subjects who are already functional community ambulators (gait speed>120cm/s43).
- 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").
Where it is running
- Shepherd Center — Atlanta, Georgia, United States
- MGH Institute of Health Professions — Boston, Massachusetts, United States
- Neurology Center of New England, P.C. — Foxborough, Massachusetts, United States
- NYU Langone Health, NYU Grossman School of Medicine — New York, New York, United States
- Oregon Health and Science university (OHSU) — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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