Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning

NCT05316519 | Terminated DMC

• 1 other identifier: 1619399
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurological Injury; Motor Disorders; Paresis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Force signal composition (Fourier transform)

  1 month post training

Study Arms (2)

Transcutaneous Vagus Nerve Stimulation

EXPERIMENTAL

Transcutaneous vagus nerve stimulation paired with visuomotor task training

Other: Transcutaneous Vagus Nerve Stimulation

Transcutaneous Stimulation (Sham)

PLACEBO COMPARATOR

Transcutaneous stimulation paired with visuomotor task training

Other: Transcutaneous Vagus Nerve Stimulation

Interventions

Transcutaneous Vagus Nerve Stimulation OTHER

Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker

Transcutaneous Stimulation (Sham); Transcutaneous Vagus Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (For prospective subjects diagnosed with stroke)
• Confirmed diagnosis of a single stroke at least six months prior to participation

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Pittsburgh Healthcare System: lead

Study Sites (1)

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Trauma, Nervous System; Motor Disorders; Paresis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: Sham-controlled

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 7, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

US (1)