Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study.
Bashar W Badran, Xiaolong Peng, Brenna Baker-Vogel...
https://pubmed.ncbi.nlm.nih.gov/37209010/Actively Recruiting
Led by Medical University of South Carolina · Updated on 2025-05-20
5
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are exploring the use of transcutaneous auricular vagus nerve stimulation taVNS combined with motor rehabilitation to improve upper limb function after stroke. Early studies suggest that applying electrical stimulation to the ear during motor rehabilitation may double the benefits by enhancing brain plasticity. This trial aims to test this innovative approach in a home setting, making the treatment more accessible, especially for those living in rural or remote areas. Participants will receive task-specific training paired with EMG-activated taVNS three times a week for two weeks at home. Before this home intervention, lab-based testing will validate the stimulation sensors to ensure they work properly for at-home use. The study focuses on assessing the safety, feasibility, and acceptability of self-administered taVNS for stroke survivors with unilateral upper limb weakness. During the study, researchers will monitor dropout rates, safety of stimulation, and compliance over the two-week period. Participants subjective ratings of feasibility and motor function improvements will also be evaluated. The trial involves regular assessments to determine how well participants can follow the treatment plan and will help identify any challenges to expanding this technology in future larger trials.
CONDITIONS
At-Home taVNS - Stroke Rehab
K
Katie Tucker
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Medical University of South Carolina
Lead Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | taVNS + task‑specific training | Standard rehabilitation |
|---|---|---|
| What this approach is | Home‑based transcutaneous auricular vagal nerve stimulation paired with task‑specific training for upper‑limb rehabilitation | Multidisciplinary physical rehabilitation including task practice and support from therapists as recommended by current guidelines |
| Role in this trial | Investigational treatment delivered in a single‑group design | Not provided in trial; included for context as current care |
| Primary use | To enhance upper‑limb motor recovery after chronic stroke when paired with training | To improve motor function and independence following stroke as standard therapy |
| How it is delivered | Participants perform task‑specific training at home three times per week for two weeks with paired auricular vagus nerve stimulation | Therapy provided in clinical settings by rehabilitation team, timing and intensity per guideline |
| Evidence status | Early pilot trials and systematic reviews suggest taVNS may improve motor function when paired with rehabilitation, but evidence remains preliminary | Multidisciplinary rehabilitation has strong high‑quality evidence supporting its role in improving function after stroke |
| Important risks | Safety being assessed in trial; earlier studies report minimal risks but device remains investigational | Standard rehabilitation is generally safe but may include risks such as overuse injury or fatigue under clinical supervision |
| Important limitations | Evidence is from small pilot studies and the current trial; long‑term benefits and optimal stimulation parameters are not yet established | Standard rehab outcomes vary by access, intensity, and individual response, and optimal timing or dose may remain uncertain |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 weeks
Participants complete task-specific training paired with transcutaneous auricular vagal nerve stimulation at home.
3 visits per week for 2 weeks (remote sessions)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Bashar W Badran, Xiaolong Peng, Brenna Baker-Vogel...
https://pubmed.ncbi.nlm.nih.gov/37209010/Medical University of South Carolina
Lead Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor