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

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ClinicalTrials.gov Identifier: NCT05437276
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : March 3, 2023
Information provided by (Responsible Party):
Helius Medical Inc

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

  2. 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,

  3. 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)

  4. 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

  5. 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

  6. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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").

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05437276

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Contact: Antonella Favit-VanPelt, MD, PhD 2159446102 afavitvanpelt@heliusmedical.com
Contact: Allison Pandaleno 2159446034 apandaleno@heliusmedical.com

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United States, Georgia
Shepherd Center Recruiting
Atlanta, Georgia, United States, 30309
Contact: Casey Kandilakis       Casey.Kandilakis@shepherd.org   
Principal Investigator: Deborah Backus, PT,Ph.D, FACRM         
United States, Massachusetts
MGH Institute of Health Professions Recruiting
Boston, Massachusetts, United States, 02129
Contact: Prudence Plummer       pplummer@mghihp.edu   
Principal Investigator: Prudence Plummer, PhD, PT, MSCS         
Neurology Center of New England, P.C. Recruiting
Foxboro, Massachusetts, United States, 02035
Contact: Rachel O'Donnell       rodonnell@myneurodr.com   
Principal Investigator: Salvatore Napoli, MD         
United States, New York
NYU Langone Health, NYU Grossman School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Luis Fernandez       Luis.Fernandez2@nyulangone.org   
Principal Investigator: Leigh E Charvet, PhD         
United States, Oregon
Oregon Health and Science university (OHSU) Recruiting
Portland, Oregon, United States, 97239
Contact: Carin Waslo       waslo@ohsu.edu   
Principal Investigator: Vijayshree Yadav, MD, MCR         
Sponsors and Collaborators
Helius Medical Inc
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Study Director: Antonella Favit-VanPelt Helius Medical Inc
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Responsible Party: Helius Medical Inc
ClinicalTrials.gov Identifier: NCT05437276    
Other Study ID Numbers: HMI-MS-PoNS-TE001
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All participating investigators will have access to deidentified individual patient data
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Study duration
Access Criteria: Participant investigators

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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
Keywords provided by Helius Medical Inc:
Gait, rehabilitation, PoNS, device, therapy, adherence, outcome
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases