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

NCT05437276 | Completed FDA Device

• 1 other identifier: HMI-MS-PoNS-TE001
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Gait, rehabilitation, PoNS, device, therapy, adherence, outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating

  14 weeks

• 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating

  14 weeks

• 1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating

  14 weeks

• Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:

  14 weeks

• Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:

  14 weeks

Study Arms (1)

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®

Interventions

PoNS® DEVICE

The PoNS device used in conjunction with rehabilitative physical therapy

People with mild to moderate Multiple Sclerosis and gait deficit

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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").

Sponsors & Collaborators

• Helius Medical Inc: lead

Study Sites (5)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

MGH Institute of Health Professions

Boston, Massachusetts, 02129, United States

Location

Neurology Center of New England, P.C.

Foxborough, Massachusetts, 02035, United States

Location

NYU Langone Health, NYU Grossman School of Medicine

New York, New York, 10016, United States

Location

Oregon Health and Science university (OHSU)

Portland, Oregon, 97239, United States

Location

Study Officials

• Antonella Favit-VanPelt

  Helius Medical Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 29, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Study duration
• Access Criteria: Participant investigators

Locations

US (5)