tVNS During Motor Training in Older Adults

Older Adults Clinical Trial

Official title:

Pairing tVNS With Motor Skill Training in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323954
• Other study ID #: H24110
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Georgia Institute of Technology
• Contact: Minoru Shinohara, PhD
• Phone: 4048941030
• Email: shinohara[@]gatech.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: June 30, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Older Adults

Intervention

Procedure:
• tVNS stimulation
Electrical stimulation to the vagus nerve area.
• Sham stimulation
Electrical stimulation to the non-vagus nerve area.

Locations

Country	Name	City	State
United States	Human Neuromuscular Physiology Lab	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Institute of Technology	University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of error reduction	The slope of the reduction in the root mean square error of finger force	2 weeks