tVNS During Motor Training in Older Adults

NCT ID: NCT06323954

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-27
• Study Completion Date: 2026-07-31

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.

Detailed Description

The participants will be randomly assigned to a tVNS or control group. They will visit the lab for four sessions. The main motor task is to trace target trajectories with finger forces. As the pre- and post-tests, all participants will be tested on a force tracing motor task with the left hand. There will be no electrical stimulation during the tests. During the training sessions, all participants will wear surface electrodes on the outer ear. The attachment sites are the tragus or cymba concha (depending on the shape and size of the ear) for the tVNS group and the earlobe for the sham group. The participants will perform finger training to trace target trajectories with their left finger forces. Participants in the tVNS and sham group will receive tVNS and sham stimulation, respectively, after successful finger trials.

Conditions

Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

tVNS stimulation

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.

Group Type: EXPERIMENTAL

tVNS stimulation

Intervention Type: PROCEDURE

Electrical stimulation to the vagus nerve area.

Sham stimulation

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

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: PROCEDURE

Electrical stimulation to the non-vagus nerve area.

Interventions

tVNS stimulation

Electrical stimulation to the vagus nerve area.

Intervention Type: PROCEDURE

Sham stimulation

Electrical stimulation to the non-vagus nerve area.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 65-84 years old across all races, genders, and ethnicities.
• Right-handed
• Physically and cognitively healthy

Exclusion Criteria

• 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)
• Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion
• Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia)
• Suspected of pregnancy
• Pregnant
• Cognitive status issues as confirmed with the Mini-Mental State Exam (MMSE <26)
• Musculoskeletal condition or injury that would limit hand range of motion

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: collaborator

Georgia Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minoru Shinohara, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia Institute of Technology

Locations

Human Neuromuscular Physiology Lab

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Minoru Shinohara, PhD

Role: CONTACT

shinohara@gatech.edu

4048941030

Facility Contacts

Minoru Shinohara, Ph.D.

Role: primary

shinohara@gatech.edu

404-894-1030

Other Identifiers

H24110

Identifier Type: -

Identifier Source: org_study_id