A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People With Multiple Sclerosis (MS)
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)
Study Start (Actual) 2022-07-01
Primary Completion (Estimated) 2023-12
Study Completion (Estimated) 2024-07
Enrollment (Estimated) 50
Study Type OBSERVATIONAL
Phase N/A
Locations:
📍 Atlanta, Georgia, United States
📍 Boston, Massachusetts, United States
📍 Foxboro, Massachusetts, United States
📍 New York, New York, United States
📍 Portland, Oregon, United States

Eligibility Criteria

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").
Ages Eligible for Study: 22 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

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 Registration Dates

  • First Submitted2022-06-17
  • First Submitted that Met QC Criteria2022-06-23
  • First Posted2022-06-29

Study Record Updates

  • Last Update Submitted that Met QC Criteria2023-03-02
  • Last Update Posted2023-03-03
  • Last Verified2023-03