tVNS During Motor Training in Older Adults

NCT06323954 | Recruiting DMC

• 1 other identifier: H24110
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn about the effect of applying transcutaneous vagus nerve stimulation (tVNS) during motor training on motor learning in older adults. The main question it aims to answer is whether applying tVNS after successful motor trials (post-success tVNS) will facilitate the rate of motor learning. Participants will be randomly assigned to tVNS or sham group and receive tVNS or sham, respectively, at the outer ear during finger control training sessions. Finger control performance will be tested before and after the training sessions without outer ear stimulation.

Conditions

Older Adults

Outcome Measures

Primary Outcomes (1)

• Rate of error reduction

  The slope of the reduction in the root mean square error of finger force

  2 weeks

Study Arms (2)

tVNS stimulation

EXPERIMENTAL

Brief electrical current will be applied to the vagus nerve area (the tragus or cymba concha, depending on the shape and size of the ear) immediately after successful trials during finger control training.

Procedure: tVNS stimulation

Sham stimulation

SHAM COMPARATOR

Brief electrical current will be applied to the non-vagus nerve area (the earlobe) immediately after successful trials during finger control training.

Procedure: Sham stimulation

Interventions

tVNS stimulation PROCEDURE

Electrical stimulation to the vagus nerve area.

tVNS stimulation

Sham stimulation PROCEDURE

Electrical stimulation to the non-vagus nerve area.

Sham stimulation

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years old across all races, genders, and ethnicities.
• Right-handed
• Physically and cognitively healthy

You may not qualify if:

• Younger than 65 years old or older than 84 years old
• Current or history of cardiac disease
• Have an implanted device such as a neurostimulator or cochlear implant
• Current or history of tympanic membrane perforation
• Have a musculoskeletal issue that prevents hand function (e.g., arthritis)
• Have a vision problem not corrected by glasses or contact lenses
• Uncorrected auditory impairments
• Had a stroke or lesion (including tumor) in the brain
• Had a head injury or brain surgery
• Suffer from frequent or severe headaches
• Had a fainting spell or syncope
• Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work
• Have any implanted device such as cardiac pacemakers, medical pumps, or intracardiac lines
• Had any brain-related conditions (i.e. multiple sclerosis, Parkinson, Alzheimer)
• Had any illness that caused brain injury (i.e. meningitis, aneurysm, brain tumor)

Sponsors & Collaborators

• Georgia Institute of Technology: lead
• University of Florida: collaborator

Study Sites (1)

Human Neuromuscular Physiology Lab

Atlanta, Georgia, 30332, United States

RECRUITING

Study Officials

• Minoru Shinohara, PhD

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minoru Shinohara, PhD

CONTACT

4048941030; shinohara@gatech.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: May 27, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)