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NCT Number: NCT06323954

tVNS During Motor Training in Older Adults

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.

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Key information

Conditions

Age range

65 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Neuromuscular Physiology Lab

Atlanta, Georgia, 30332, United States

Location status: Recruiting

Location contact

Minoru Shinohara, Ph.D.

CONTACT

[email protected]

404-894-1030

Minoru Shinohara, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 65-84 years old across all races, genders, and ethnicities.
  • 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

Treatment and study plan

tVNS stimulation

Procedure

Electrical stimulation to the vagus nerve area.

Sham stimulation

Procedure

Electrical stimulation to the non-vagus nerve area.

Primary outcomes

  1. Rate of error reduction

    Time frame: 2 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Minoru Shinohara, PhD

CONTACT

[email protected]

4048941030

Sponsors and collaborators

Lead sponsor

Georgia Institute of Technology

Other

Collaborators

  • University of Florida

Registry information

Official study title

Pairing tVNS With Motor Skill Training in Older Adults

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 21, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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