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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: PoNS®


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| People with mild to moderate Multiple Sclerosis and gait deficit<br>All enrolled subjects will go through 14 weeks therapy: Phase 1 (2-week in-clinic supervised PoNS therapy) followed by Phase 2 (12-week period of at-home unsupervised - PoNS therapy). Six-Month Observation: subjects will be asked to return to the clinic six months after the end of the 14-week course of therapy for an observation visit. Individual subjects could receive, upon investigator's opinion of need, an ad hoc second 12-week course of PoNS therapy. | Device: PoNS®<br>* The PoNS device used in conjunction with rehabilitative physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure subjects' adherence to PoNS therapy (device + physical therapy) | Subjects' adherence to at-home PoNS therapy (device + physical therapy) over 12 weeks following 2 weeks of supervised PoNS therapy at a physical therapy clinic and the relationship between subject's therapy adherence behavior and therapeutic functional outcomes as measured by the Dynamic Gait Index (DGI). | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating | a. subject's improvement of gait as measured by the Timed 25-foot Walk Test | 14 weeks | 
| 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating | b. balance deficits as measured by the Timed Up and Go Cognitive (TUG-Cog) Test, | 14 weeks | 
| 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating | c. investigator's impression of clinical improvement as measured by the Clinical Global Impression (CGI) | 14 weeks | 
| Clinical improvement among subjects receiving a second course of PoNS therapy as measured by: | a. the rate and timing of investigator initiated second course of therapy | 14 weeks | 
| Clinical improvement among subjects receiving a second course of PoNS therapy as measured by: | b. the magnitudes of improvements in gait and balance deficits during the second course of therapy | 14 weeks | 
| 3) Association between likelihood of second course of therapy and magnitudes of improvement with adherence during the initial therapy | adherence during the second course of therapy, and changes in adherence | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, rehabilitation, PoNS, device, therapy, adherence, outcome