Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning

Not Applicable

Terminated

• Conditions: Motor Disorders; Neurological Injury; Paresis
• Interventions: Other: Transcutaneous Vagus Nerve Stimulation

• Registration Number: NCT05316519
• Lead Sponsor: VA Pittsburgh Healthcare System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2022-06-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

(For prospective subjects diagnosed with stroke)

• Confirmed diagnosis of a single stroke at least six months prior to participation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous Vagus Nerve Stimulation	Transcutaneous Vagus Nerve Stimulation	Transcutaneous vagus nerve stimulation paired with visuomotor task training
Transcutaneous Stimulation (Sham)	Transcutaneous Vagus Nerve Stimulation	Transcutaneous stimulation paired with visuomotor task training

Primary Outcome Measures

Name	Time	Method
Precision grip stability (coefficient of variation or root-mean-square error)	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 Outcome Measures

Name	Time	Method
Force signal composition (Fourier transform)	1 month post training	The force signal oscillates at various frequencies and will be decomposed with a Fourier transform to quantify the relative contribution of higher frequencies.

Trial Locations

Locations (1)

Human Engineering Research Laboratories; 🇺🇸 Pittsburgh, Pennsylvania, United States