Using a device to improve balance in stroke survivors
Cranial-nerve Non-invasive Neuromodulation and Dynamic Balance in Chronic Stroke Survivors
This study tests if a device called PoNS, used alongside balance training, can help stroke survivors improve their walking and stability.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years to 85 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05135533 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the Portable Neuromodulation Stimulator (PoNS) in conjunction with gait and balance training to enhance postural and walking stability in individuals who have experienced a stroke. Participants will receive either the PoNS therapy or a sham treatment while engaging in balance training exercises. The goal is to gather evidence on how this non-invasive stimulation can aid recovery and improve mobility in stroke survivors. The study focuses on individuals who have residual impairments following their stroke, specifically targeting those with lower extremity weakness.
Who should consider this trial
Good fit: Ideal candidates are individuals who have had a stroke at least six months prior and exhibit residual lower extremity weakness.
Not a fit: Patients with pre-existing neurological disorders or severe orthopedic issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve balance and mobility in stroke survivors, enhancing their quality of life.
How similar studies have performed: While the use of neuromodulation for balance improvement is a growing field, this specific approach with PoNS therapy is relatively novel and has not been extensively tested in stroke populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Shraddha Srivastava, PhD
- Email: srivasts@musc.edu
- Phone: 843-792-6165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.