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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date May 2024
Source VA Pittsburgh Healthcare System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Transcutaneous Vagus Nerve Stimulation
Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker

Locations

Country Name City State
United States Human Engineering Research Laboratories Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

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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