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

March 2, 2023 updated by: Helius Medical Inc

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

Recruiting

Conditions

Intervention / Treatment

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 (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Shepherd Center
        • Contact:
        • Principal Investigator:
          • Deborah Backus, PT,Ph.D, FACRM
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Recruiting
        • MGH Institute of Health Professions
        • Contact:
        • Principal Investigator:
          • Prudence Plummer, PhD, PT, MSCS
      • Foxboro, Massachusetts, United States, 02035
        • Recruiting
        • Neurology Center of New England, P.C.
        • Contact:
        • Principal Investigator:
          • Salvatore Napoli, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health, NYU Grossman School of Medicine
        • Contact:
        • Principal Investigator:
          • Leigh E Charvet, PhD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University (OHSU)
        • Contact:
        • Principal Investigator:
          • Vijayshree Yadav, MD, MCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 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).
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
Time Frame: 14 weeks
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
Time Frame: 14 weeks
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
Time Frame: 14 weeks
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:
Time Frame: 14 weeks
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:
Time Frame: 14 weeks
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
Time Frame: 14 weeks
adherence during the second course of therapy, and changes in adherence
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helius Medical Inc

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

July 1, 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 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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