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Pilot protocol terminated to begin trial.
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Vagus nerve stimulation (VNS) activates neural pathways leading to the release of chemicals that promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear activates neural pathways implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms that are modulated by auricular stimulation and its potential to enhance motor learning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Experimental | Transcutaneous vagus nerve stimulation paired with visuomotor task training |
|
| Transcutaneous Stimulation (Sham) | Placebo Comparator | Transcutaneous stimulation paired with visuomotor task training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Other | Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Precision grip stability (coefficient of variation or root-mean-square error) | The ability to stabilize precision grip according to target force and/or preload force will be quantified by calculating coefficient of variation (CV) or root-mean-square error (RMSE) which characterize variability in relation to mean force or target force. | 1 month post training |
| Measure | Description | Time Frame |
|---|---|---|
| Force signal composition (Fourier transform) | The force signal oscillates at various frequencies and will be decomposed with a Fourier transform to quantify the relative contribution of higher frequencies. | 1 month post training |
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Inclusion Criteria:
(For prospective subjects diagnosed with stroke)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Engineering Research Laboratories | Pittsburgh | Pennsylvania | 15206 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 16, 2025 | |
| Reset | May 5, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 16, 2025 | May 5, 2025 |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D000068079 | Motor Disorders |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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Sham-controlled
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Single-blind
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |