Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning

NCT ID: NCT05316519

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neurological Injury Motor Disorders Paresis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sham-controlled
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Single-blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transcutaneous Vagus Nerve Stimulation

Transcutaneous vagus nerve stimulation paired with visuomotor task training

Group Type EXPERIMENTAL

Transcutaneous Vagus Nerve Stimulation

Intervention Type OTHER

Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker

Transcutaneous Stimulation (Sham)

Transcutaneous stimulation paired with visuomotor task training

Group Type PLACEBO_COMPARATOR

Transcutaneous Vagus Nerve Stimulation

Intervention Type OTHER

Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcutaneous Vagus Nerve Stimulation

Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Pittsburgh Healthcare System

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael A. Urbin

Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1619399

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Transauricular Vagus Nerve Stimulation in Children
NCT06168071 ENROLLING_BY_INVITATION NA
taVNS Treatment for Fibromyalgia
NCT04777500 NOT_YET_RECRUITING NA
Mapping Auricular Vagus Nerve Circuitry
NCT00200889 RECRUITING EARLY_PHASE1