NCT06336720Active, not recruiting
PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study
Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors. Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization. Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 1 May 2024
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Helius Medical Inc
- Diseases
- Stroke
- NCT number
- NCT06336720
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 May 2024 to the primary completion date, 30 Apr 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-existing neurological disorders or previous stroke affecting the other hemisphere.
- Concurrent daily use of transcutaneous electric nerve stimulation (TENS) and/or other peripheral stimulation devices (i.e. Bioness®)
- Neurostimulation therapy over the previous 6 months
Other illness
- Areas of recent bleeding or open wounds; or areas that lack normal sensation on the tongue.
- Diagnosis of dementia or mild cognitive impairment
- Cancer treatment within the past year.
- Chronic infectious diseases.
Other
- Severe arthritis or orthopedic problems that limit passive range of motion.
- Nonremovable metal orthodontic devices.
- Oral health problems.
- Pregnancy.
- Sensitivity to nickel, gold or copper.
Who the study is looking for
- Men and women ≥ 18 and \< 85 years of age with a diagnosis ischemic or hemorrhagic stroke at \> 6 months since stroke onset event.
- FMA-LE scores \< 34 at screening with residual paresis in the lower extremity.
- Able to walk at least 10 feet with or without assistive device.
- FGA score \< 23 at screening.
- Montreal Cognitive Assessment 5-min (MoCA 5-min) ≥ 6
- Able to understand, learn and apply instructions on how to operate the PoNS device and perform the rehabilitation exercise program.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shepherd Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| MGH Institute of Health Professions Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Neurology Center of New England P.C. Coordinator of this site? Confirm its status | Foxborough | United States | Unknown status |
| Brooks Rehabilitation Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Rehabologym Corp Coordinator of this site? Confirm its status | Tarrytown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.