Portable Neuromodulation Stimulator (PoNS): The PoNS device does not deliver stimulation produced by amplitude-controlled, biphasic pulses to the anterior superior surface of the tongue through gold-plated electrodes plus physical therapy.
Portable Neuromodulation Stimulator (PoNS): The PoNS device delivers stimulation produced by amplitude-controlled, biphasic pulses to the anterior superior surface of the tongue through gold-plated electrodes plus physical therapy.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Men and women ≥ 18 and \< 85 years of age with a diagnosis ischemic or hemorrhagic stroke at \> 6 months since stroke onset event.
2. FMA-LE scores \< 34 at screening with residual paresis in the lower extremity.
3. Able to walk at least 10 feet with or without assistive device.
4. FGA score \< 23 at screening.
5. Montreal Cognitive Assessment 5-min (MoCA 5-min) ≥ 6
6. Able to understand, learn and apply instructions on how to operate the PoNS device and perform the rehabilitation exercise program.
Exclusion Criteria:
1. Pre-existing neurological disorders or previous stroke affecting the other hemisphere.
2. Severe arthritis or orthopedic problems that limit passive range of motion.
3. Areas of recent bleeding or open wounds; or areas that lack normal sensation on the tongue.
4. Diagnosis of dementia or mild cognitive impairment
5. Concurrent daily use of transcutaneous electric nerve stimulation (TENS) and/or other peripheral stimulation devices (i.e. Bioness®)
6. Neurostimulation therapy over the previous 6 months
7. Cancer treatment within the past year.
8. Nonremovable metal orthodontic devices.
9. Oral health problems.
10. Chronic infectious diseases.
11. Pregnancy.
12. Sensitivity to nickel, gold or copper.
Primary outcome measure(s)
Primary safety endpoints — 12 week treatment - related serious adverse events (SAE) over 12 week treatment
Trial sites (3)
Facility
City
Region
Status
Synaptic Health
Calgary
Alberta
Neuphysio
London
Ontario
Neuro-Concept
Verdun
Quebec
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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