Clinical trial NCT05437276: A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People With Multiple Sclerosis (MS)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)
Keywords: Gait, rehabilitation, PoNS, device, therapy, adherence, outcome
Lead sponsor: Helius Medical Inc
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 43
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 50 subjects across 10-12 clinical sites in the U.S. will participate in this study. Candidates with scores \< 6.5 on the Kurtzke Expanded Disability Status Scale (EDSS) (from mild impairment up to use of an assistive device) will be considered for participation. Subjects will have no major co-morbidities (e.g., neurological disorders, uncontrolled pain, hypertension, or diabetes). All subjects, if on medications, will not have had any major changes in type or dosage of medication within three months of enrollment. Subjects with oral health problems or neurological disorders other than those attributed to their primary diagnosis will be excluded.

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.

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.

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").

Primary outcomes:
measure: Measure subjects' adherence to PoNS therapy (device + physical therapy)
timeFrame: 14 weeks
Secondary outcomes:
measure: 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
timeFrame: 14 weeks
measure: 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
timeFrame: 14 weeks
measure: 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
timeFrame: 14 weeks
measure: Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:
timeFrame: 14 weeks
measure: Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:
timeFrame: 14 weeks
measure: 3) Association between likelihood of second course of therapy and magnitudes of improvement with adherence during the initial therapy
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Boston
country: United States
facility: MGH Institute of Health Professions
state: Massachusetts
city: Foxboro
country: United States
facility: Neurology Center of New England, P.C.
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health, NYU Grossman School of Medicine
state: New York
city: Portland
country: United States
facility: Oregon Health and Science university (OHSU)
state: Oregon
Study officials:
affiliation: Helius Medical Inc
name: Antonella Favit-VanPelt
role: STUDY_DIRECTOR
References: