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

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 therapy by Helius Medical and certified as a clinic PoNS trainer (Phase 1) followed by 12 weeks of at-home unsupervised PoNS therapy Once weekly in-clinic PoNS therapy session (Phase 2). Subjects will be then asked to return to the clinic six month after the end of the study Phase 2 to assess maintenance of PoNS therapy effects.

Inclusion criteria

• 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 criteria

• 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").