A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People With Multiple Sclerosis (MS) (PoNSTEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05437276|
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : March 3, 2023
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|Condition or disease||Intervention/treatment|
|Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)||Device: PoNS®|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
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.
The PoNS device used in conjunction with rehabilitative physical therapy
- 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).
- 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
- 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,
- 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)
- 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
- 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
- 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
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.
|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|
- 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.
- Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
- 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").
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
|Contact: Antonella Favit-VanPelt, MD, PhDfirstname.lastname@example.org|
|Contact: Allison Pandalenoemail@example.com|
|United States, Georgia|
|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 firstname.lastname@example.org|
|Principal Investigator: Prudence Plummer, PhD, PT, MSCS|
|Neurology Center of New England, P.C.||Recruiting|
|Foxboro, Massachusetts, United States, 02035|
|Contact: Rachel O'Donnell email@example.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 firstname.lastname@example.org|
|Principal Investigator: Vijayshree Yadav, MD, MCR|
|Study Director:||Antonella Favit-VanPelt||Helius Medical Inc|
|Responsible Party:||Helius Medical Inc|
|Other Study ID Numbers:||
|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|
Clinical Study Report (CSR)
|Time Frame:||Study duration|
|Access Criteria:||Participant investigators|
|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|
Gait, rehabilitation, PoNS, device, therapy, adherence, outcome
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