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A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People With Multiple Sclerosis (MS)

CompletedN/A

Sponsor: Helius Medical Inc

Conditions: Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)

Interventions: PoNS®

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Men and women ≥ 22 years of age with a diagnosis of MS.
2. EDSS scores \< 6.5 at screening; a demonstrated gait deficit.
3. Can walk at least 10 meters with or without the use of walking aids.
4. Participants must be stable without relapse for at least 60 days and agree to PoNS therapy regimen.

Exclusion Criteria:

1. Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
2. Dementia.
3. Subjects who are currently attending physical rehabilitation and are unwilling to switch to PoNS-specific physical therapy regimen.
4. Subjects who are already functional community ambulators (gait speed\>120cm/s43).
5. 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").

Locations (5)

Atlanta, Georgia, United States
Boston, Massachusetts, United States
Foxborough, Massachusetts, United States
New York, New York, United States
Portland, Oregon, United States