Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)PoNSTEPNCT05437276
A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People With Multiple Sclerosis (MS)
An observational study of Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS), run by Helius Medical Inc at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)
- What is being tested?
- PoNS®
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jul 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
- Dementia.
- 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").
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Shepherd Center
Atlanta, Georgia, 30309
MGH Institute of Health Professions
Boston, Massachusetts, 02129
Neurology Center of New England, P.C.
Foxborough, Massachusetts, 02035
NYU Langone Health, NYU Grossman School of Medicine
New York, New York, 10016
Oregon Health and Science university (OHSU)
Portland, Oregon, 97239
About this study
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
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.
Read the 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.
- Being tested
- PoNS®
- Keywords
- Gait, rehabilitation, PoNS, device, therapy, adherence, outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoNS®Device
The PoNS device used in conjunction with rehabilitative physical therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PoNS® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 weeks
Secondary outcomes (6)
1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
- subject's improvement of gait as measured by the Timed 25-foot Walk Test
Measured: 14 weeks
1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
- balance deficits as measured by the Timed Up and Go Cognitive (TUG-Cog) Test,
Measured: 14 weeks
1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
- investigator's impression of clinical improvement as measured by the Clinical Global Impression (CGI)
Measured: 14 weeks
Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:
- the rate and timing of investigator initiated second course of therapy
Measured: 14 weeks
Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:
- the magnitudes of improvements in gait and balance deficits during the second course of therapy
Measured: 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
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helius Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonella Favit-VanPelt, Study director, Helius Medical Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437276
- Sponsor's protocol ID
- HMI-MS-PoNS-TE001
- Acronym
- PoNSTEP
- Status last verified
- Mar 2025
- First submitted
- 17 Jun 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All participating investigators will have access to deidentified individual patient data
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05437276
- Acronym / sponsor ID
- PoNSTEP / HMI-MS-PoNS-TE001
- Keywords
- Gait, rehabilitation, PoNS, device, therapy, adherence, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Helius Medical IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with mild to moderate Multiple Sclerosis and gait deficit | – | Device: PoNS®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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
- Dementia.
- 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").
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PoNS®The PoNS device used in conjunction with rehabilitative physical therapy | Device | People with mild to moderate Multiple Sclerosis and gait deficit |
Primary outcome
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).
6 secondary outcomes
1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
Time frame: 14 weeks
1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
Time frame: 14 weeks
1) Clinical improvement and its relationship to adherence over the 14-week course of PoNS therapy by evaluating
Time frame: 14 weeks
Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:
Time frame: 14 weeks
Clinical improvement among subjects receiving a second course of PoNS therapy as measured by:
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Yes. All participating investigators will have access to deidentified individual patient data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonella Favit-VanPelt study director
Helius Medical Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Impairment Due to Mild/Moderate Multiple Sclerosis (MS), run by Helius Medical Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure subjects' adherence to PoNS therapy (device + physical therapy) (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.