At-home electrical stimulation for stroke rehabilitation
Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation
This study tests whether using a special ear stimulation device at home can help stroke survivors improve their arm movement while they do rehabilitation exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06616831 on ClinicalTrials.gov |
What this trial studies
This study explores the use of transcutaneous auricular vagus nerve stimulation (taVNS) combined with motor rehabilitation for stroke survivors experiencing upper limb motor function deficits. The approach aims to enhance the benefits of rehabilitation by delivering electrical stimulation to the ear while patients perform rehabilitation tasks at home. The study will validate the safety and feasibility of this at-home intervention and assess its acceptability among participants. By making this technology accessible, the study seeks to improve outcomes for individuals in rural and remote areas.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have experienced an ischemic or hemorrhagic stroke at least six months prior and have unilateral limb weakness.
Not a fit: Patients with other neurological disorders affecting motor function or those with a history of significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor function recovery in stroke survivors.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior; * Ability to give consent; * Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks; * active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks; * Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values. Exclusion Criteria: * Other concomitant neurological disorders affecting upper extremity motor function; * Presence of Dysphagia or aspiration difficulties; * Prior injury to vagus nerve; * Pregnancy; * Documented history of dementia before or after stroke; * Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment; * Uncontrolled hypertension; * Botox injections within 4 weeks of the first day of rehabilitation therapy.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Bashar Badran, PhD — Medical University of South Carolina
- Study coordinator: Katie Tucker
- Email: tuckekat@musc.edu
- Phone: 843-792-9502
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.