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RecruitingNCT06323954Updated Jul 22, 2026

tVNS During Motor Training in Older Adults

An interventional study of tVNS stimulation and Sham stimulation in Older Adults, sponsored by Georgia Institute of Technology. Recruiting at 1 site in United States. Open to participants aged 65 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Georgia Institute of Technology · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
65 Years to 84 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Older Adults
03

In context

Lead sponsor

Georgia Institute of Technology is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: tVNS stimulation

  • Sham comparator
    Sham stimulation

    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

  • ProceduretVNS stimulation

    Electrical stimulation to the vagus nerve area.

  • ProcedureSham stimulation

    Electrical stimulation to the non-vagus nerve area.

06

What researchers measure

Primary outcomes

  1. Rate of error reduction

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

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Human Neuromuscular Physiology Lab
    Atlanta, Georgia 30332, United States
    • Minoru Shinohara, Ph.D. · Contact · shinohara@gatech.edu · 404-894-1030
    • Minoru Shinohara, Ph.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06323954
Lead sponsor
Georgia Institute of Technology
Collaborators
University of Florida
Responsible party
Sponsor
First posted
Mar 21, 2024
Start date
May 27, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Jul 22, 2026

Study contacts

Minoru Shinohara, PhD
Contact
shinohara@gatech.edu
4048941030
Minoru Shinohara, PhD
principal investigator · Georgia Institute of Technology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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