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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.
This study seeks to advance prior research conducted here at MUSC exploring the use of transcutaneous auricular vagus nerve stimulation (taVNS) paired with motor rehabilitation to improve motor function post-stroke. Early evidence from a recently completed NIH-funded, clinical trial suggests that our new approach of delivering electrical stimulation to the ear at the same time as motor rehabilitation double the clinical benefits of motor rehabilitation. These benefits are due in part to a facilitation of neuroplasticity caused by activating the auricular branch of the vagus nerve.
This project takes this approach one step further, moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas. In order to accomplish this, investigators will a) conduct lab-based testing and validation of the stimulation triggering sensors for at-home use, and b) determine the safety, feasibility, and acceptability of at-home taVNS in five stroke survivors with unilateral upper limb motor deficits.
Investigators hypothesize that our lab-based validation will facilitate an optimized home intervention. Furthermore, investigators hypothesize taVNS will be safe and feasible to self-administer in the at-home setting. Lastly, investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training | Experimental | Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training | Device | Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility through dropout rates | Dropout rates will be assessed over the course of the study. | 2 weeks |
| Safety of stimulation | Any side effects or adverse events will be assessed. | 2 weeks |
| Compliance | Compliance with study procedures will be assessed every study visit. | 2 weeks |
| Subjective ratings of feasibility. | Feasibility will be assessed with subjective ratings on subject's ability to complete study procedures at home. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with at-home sessions | The total number of completed at-home sessions will be measured. The total stimulation duration completed within each session. Benchmarks of >80% total motor rehabilitation sessions completed, and 45 minute in-session duration will be the feasibility cutoffs for the analysis. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Tucker | Contact | 843-792-9502 | tuckekat@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bashar Badran, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37209010 | Background | Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2026 | Jun 5, 2026 | 4 | ||
| Jun 15, 2026 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Motor Function |
Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Fugl-Meyer Assessment (FMA). |
| 2 weeks |
| Jul 9, 2026 |
| 5 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |