Motor Disorders Clinical Trial
Official title:
Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential
NCT number | NCT05316519 |
Other study ID # | 1619399 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | December 31, 2023 |
Verified date | May 2024 |
Source | VA Pittsburgh Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: (For prospective subjects diagnosed with stroke) - Confirmed diagnosis of a single stroke at least six months prior to participation Exclusion Criteria: - History of vestibular disorders or dizziness - Diagnosis of neurological disorders affecting movement - Ocular disease and/or impairment in more than one eye - Pregnant or expecting to become pregnant - Difficulty maintaining alertness and/or remaining still |
Country | Name | City | State |
---|---|---|---|
United States | Human Engineering Research Laboratories | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
VA Pittsburgh Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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