CompletedNot Applicable

Neuromodulation and Dynamic Balance in Stroke

United States53 participantsStarted 2023-08-28

Plain-language summary

Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke.

Who can participate

Age range22 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least six months since the onset of Ischemic or hemorrhagic stroke. * Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score \< 34). * Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study. * Can walk at least 10 feet with and without assistive device. * Functional Gait Assessment score \<22. Exclusion Criteria: * Pre-existing neurological disorders. * Previous stroke affecting the other hemisphere . * Severe arthritis or orthopedic problems that limit passive range of motion. * Areas of recent bleeding or open wounds. * Lack normal sensation on the tongue. * Received treatment for cancer within the past year. * Non-removable metal orthodontic devices. * Oral health problems. * Are sensitive to nickel, gold or copper. * Chronic infectious diseases. * Are pregnant. * Have dementia

What they're measuring

Change in gait speed

Timeframe: Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks

Change in balance

Timeframe: Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeks

Trial details

NCT IDNCT05135533

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-24