Status:
COMPLETED
A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People With Multiple Sclerosis (MS)
Lead Sponsor:
Helius Medical Inc
Conditions:
Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)
Eligibility:
All Genders
22+ years
Brief Summary
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-cente...
Detailed Description
Study participants will undergo fourteen weeks of on-label PoNS therapy and, specifically, two weeks in-clinic PoNS therapy directly supervised by a physical therapist who has been trained on PoNS the...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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").
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05437276
Start Date
July 1 2022
End Date
December 31 2024
Last Update
March 28 2025
Active Locations (5)
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1
Shepherd Center
Atlanta, Georgia, United States, 30309
2
MGH Institute of Health Professions
Boston, Massachusetts, United States, 02129
3
Neurology Center of New England, P.C.
Foxborough, Massachusetts, United States, 02035
4
NYU Langone Health, NYU Grossman School of Medicine
New York, New York, United States, 10016