Noninvasive stimulation of the vagus nerve to improve motor learning after stroke
Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms
This study is testing if a new way to stimulate the vagus nerve through the ear can help people who have had a stroke improve their motor skills and learn better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06282406 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on motor learning in individuals who have experienced a stroke. By applying electrical current to specific areas of the external ear, the study aims to activate neural pathways that may enhance learning and rehabilitation outcomes. The research focuses on understanding the physiological mechanisms involved in this process, particularly how taVNS influences brain states associated with learning. Participants will be compared against a sham stimulation group to assess the efficacy of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 who have experienced a single stroke resulting in hand impairment at least six months prior to participation.
Not a fit: Patients with neurological disorders other than stroke, vestibular disorders, or those with certain medical implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for stroke patients by improving motor learning capabilities.
How similar studies have performed: Previous studies have shown promise in using vagus nerve stimulation for enhancing rehabilitation, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ALL PROSPECTIVE SUBJECTS: 1. 18-75 years of age PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE: 2. Diagnosis of a single stroke resulting in hand impairment 3. Diagnosis of stroke at least six months prior to the time of participation Exclusion Criteria: ALL PROSPECTIVE SUBJECTS: 1. History of vestibular disorders or dizziness 2. Difficulty maintaining alertness and/or remaining still 3. Pregnant or expecting to become pregnant 4. Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement 5. Ocular disease and/or impairment in more than one eye 6. History of seizure and/or epilepsy 7. Implants, devices, or foreign objects in the brain/body that are incompatible with MRI 8. Body size that is incompatible with MRI scanner dimensions 9. Anyone already enrolled and actively participating in another greater than minimal risk study. PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE: 10. Other impairments secondary to stroke (e.g., attention, cognition, etc.) that would interfere with the ability to understand study goals or follow simple instructions, as judged by the investigators.
Where this trial is running
Pittsburgh, Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Michael A. Urbin, PhD — VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- Study coordinator: Michael A Urbin, PhD
- Email: Michael.Urbin@va.gov
- Phone: (412) 688-6000
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.