Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning

April 14, 2023 updated by: Michael A. Urbin, VA Pittsburgh Healthcare System

Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Recruiting
        • Human Engineering Research Laboratories
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Vagus Nerve Stimulation
Transcutaneous vagus nerve stimulation paired with visuomotor task training
Other: Transcutaneous Vagus Nerve Stimulation
Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker
Placebo Comparator: Transcutaneous Stimulation (Sham)
Transcutaneous stimulation paired with visuomotor task training
Other: Transcutaneous Vagus Nerve Stimulation
Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month post training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Force signal composition (Fourier transform)
Time Frame: 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.
1 month post training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Pittsburgh Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1619399

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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