Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Precision grip stability (coefficient of variation or root-mean-square error)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Masking Description
Single-blind
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Precision grip stability (coefficient of variation or root-mean-square error)
Time Frame: 1 month post training
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.
Secondary Outcomes
- Force signal composition (Fourier transform)(1 month post training)
Investigators
Michael A. Urbin
Scientist
VA Pittsburgh Healthcare System