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Clinical Trials/NCT05316519
NCT05316519
Terminated
Not Applicable

Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential

VA Pittsburgh Healthcare System1 site in 1 country4 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurological Injury
Sponsor
VA Pittsburgh Healthcare System
Enrollment
4
Locations
1
Primary Endpoint
Precision grip stability (coefficient of variation or root-mean-square error)
Status
Terminated
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael A. Urbin

Scientist

VA Pittsburgh Healthcare System

Eligibility Criteria

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)

Study Sites (1)

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