Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning

Motor Disorders Clinical Trial

Official title:

Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05316519
• Other study ID #: 1619399
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Motor Disorders
• Neurological Injury
• Paresis
• Trauma, Nervous System

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