NCT06470009Active, not recruiting
Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Randomized Controlled Trial.
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
Double blind, randomized, placebo controlled, interventional clinical trial investigating the efficacy and safety of PoNS therapy on improving dynamic gait and balance deficits in chronic stroke survivors.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 17 Jun 2024
- Start date
- 12 Jun 2024
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- Helius Medical Inc
- Diseases
- Stroke
- NCT number
- NCT06470009
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 12 Jun 2024 to the primary completion date, 30 Jul 2025
- 3 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 (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Synaptic Health Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Neuphysio Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Neuro-Concept Coordinator of this site? Confirm its status | Verdun | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.