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

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

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.

Study Overview

• Status: Completed
• Conditions: Gait Impairment Due to Mild/moderate Multiple Sclerosis (MS)
• Intervention / Treatment: Device: PoNS®

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • MGH Institute of Health Professions
    • Foxboro, Massachusetts, United States, 02035
      • Neurology Center of New England, P.C.
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health, NYU Grossman School of Medicine
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University (OHSU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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").

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helius Medical Inc
• Investigators: Study Director: Antonella Favit-VanPelt, Helius Medical Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Gait, rehabilitation, PoNS, device, therapy, adherence, outcome
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: HMI-MS-PoNS-TE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All participating investigators will have access to deidentified individual patient data
• IPD Sharing Time Frame: Study duration
• IPD Sharing Access Criteria: Participant investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No