PoNS TEP: A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People With Multiple Sclerosis (MS)
Study Details
Study Description
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-center study investigating the relationship between subject's adherence to PoNS therapy and therapeutic outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| People with mild to moderate Multiple Sclerosis and gait deficit 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®
The PoNS device used in conjunction with rehabilitative physical therapy
|
Outcome Measures
Primary Outcome Measures
- Measure subjects' adherence to PoNS therapy (device + physical therapy) [14 weeks]
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).
Secondary Outcome Measures
- 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating [14 weeks]
a. subject's improvement of gait as measured by the Timed 25-foot Walk Test
- 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating [14 weeks]
b. balance deficits as measured by the Timed Up and Go Cognitive (TUG-Cog) Test,
- 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating [14 weeks]
c. investigator's impression of clinical improvement as measured by the Clinical Global Impression (CGI)
- Clinical improvement among subjects receiving a second course of PoNS therapy as measured by: [14 weeks]
a. the rate and timing of investigator initiated second course of therapy
- Clinical improvement among subjects receiving a second course of PoNS therapy as measured by: [14 weeks]
b. the magnitudes of improvements in gait and balance deficits during the second course of therapy
- 3) Association between likelihood of second course of therapy and magnitudes of improvement with adherence during the initial therapy [14 weeks]
adherence during the second course of therapy, and changes in adherence
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women ≥ 22 years of age with a diagnosis of MS.
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EDSS scores < 6.5 at screening; a demonstrated gait deficit.
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Can walk at least 10 meters with or without the use of walking aids.
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Participants must be stable without relapse for at least 60 days and agree to PoNS therapy regimen.
Exclusion Criteria:
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Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
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Dementia.
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Subjects who are currently attending physical rehabilitation and are unwilling to switch to PoNS-specific physical therapy regimen.
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Subjects who are already functional community ambulators (gait speed>120cm/s43).
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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").
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Helius Medical Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HMI-MS-PoNS-TE001