Multiple SclerosisPoNSREMNCT06930339
Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Helius Medical Inc at 1 site in United States.
Trial summary
The Registry will be designed to gather information over 3 years. This important health economic information will help to establish the value of the PoNS Device on key therapeutic outcomes. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Portable Neuromodulation Stimulator (PoNS)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Apr 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The registry is designed to collect retrospective clinical/medical outcome data on the therapeutic response of MS patients with gait deficit who underwent at least an initial 14-week PoNS Therapy course.
Who may be able to join
- Diagnosis of gait deficit due to MS
Who cannot join
- unable to ambulate with or without an assisting device
Trial locations and contacts
1 site in 1 country.
About this study
The Registry will be designed to gather information over 3 years. This important health economic information will help to establish the value of the PoNS Device on key therapeutic outcomes. These outcomes will include:
disease-associated injury risks (i.e., falls), onset of new comorbidities and/or worsening/improvement of existing medical condition(s) (other than gait deficit/impairment), need for new pharmacological/non-pharmacological intervention or increase/decrease of ongoing pharmacotherapy or other non-pharmacological intervention, increase/decrease of in patient/outpatient hospital and/or office visits or stays, side effects.
By participation in the Registry, patients and physicians will be providing Helius with access to information about medical history, medical diagnoses, clinical symptom presentations, vocational information, medications, pharmacologic and non-pharmacologic prescriptions, hospitalization and healthcare visits, and any reported therapy's adverse events.
- Conditions
- Multiple Sclerosis
- Being tested
- Portable Neuromodulation Stimulator (PoNS)
- Keywords
- Gait deficit, PoNS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Neuromodulation Stimulator (PoNS)Device
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology
Balance and Gait deficit improvement after physical therapy rehabilitation with PoNS device over one or more courses of 14-week therapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 May 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Helius Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930339
- Sponsor's protocol ID
- HMI-MS-PoNS-RE001
- Acronym
- PoNSREM
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06930339
- Acronym / sponsor ID
- PoNSREM / HMI-MS-PoNS-RE001
- Conditions
- Multiple Sclerosis
- Keywords
- Gait deficit, PoNS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Helius Medical IncIndustry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 16 Apr 2025 (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.
The Registry will be designed to gather information over 3 years. This important health economic information will help to establish the value of the PoNS Device on key therapeutic outcomes. These outcomes will include:
disease-associated injury risks (i.e., falls), onset of new comorbidities and/or worsening/improvement of existing medical condition(s) (other than gait deficit/impairment), need for new pharmacological/non-pharmacological intervention or increase/decrease of ongoing pharmacotherapy or other non-pharmacological intervention, increase/decrease of in patient/outpatient hospital and/or office visits or stays, side effects.
By participation in the Registry, patients and physicians will be providing Helius with access to information about medical history, medical diagnoses, clinical symptom presentations, vocational information, medications, pharmacologic and non-pharmacologic prescriptions, hospitalization and healthcare visits, and any reported therapy's adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry is designed to collect retrospective clinical/medical outcome data on the therapeutic response of MS patients with gait deficit who underwent at least an initial 14-week PoNS Therapy course.
Key inclusion criteria (1 listed)
- Diagnosis of gait deficit due to MS
Key exclusion criteria (1 listed)
- unable to ambulate with or without an assisting device
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 |
|---|---|---|
| Portable Neuromodulation Stimulator (PoNS)No intervention | Device | – |
Primary outcome
Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology
Time frame: 3 years
Balance and Gait deficit improvement after physical therapy rehabilitation with PoNS device over one or more courses of 14-week therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Helius Medical Inc at 1 site 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology (time frame: 3 years). 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 16 Apr 2025.