Older AdultsNCT06323954
tVNS During Motor Training in Older Adults
A study testing tVNS stimulation in people with Older Adults, run by Georgia Institute of Technology at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- tVNS stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-84 years old across all races, genders, and ethnicities.
- Physically and cognitively healthy
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Human Neuromuscular Physiology Lab
Atlanta, Georgia, 30332
Minoru Shinohara, Ph.D., 404-894-1030, shinohara@gatech.edu
Minoru Shinohara, Ph.D.
About this study
Official title: Pairing tVNS With Motor Skill 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.
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.
- Conditions
- Older Adults
- Being tested
- tVNS stimulation, Sham stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tVNS stimulationProcedure or surgery
Electrical stimulation to the vagus nerve area.
Sham stimulationProcedure or surgery
Electrical stimulation to the non-vagus nerve area.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of error reduction
The slope of the reduction in the root mean square error of finger force
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start27 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Minoru Shinohara, PhD, Principal investigator, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323954
- Sponsor's protocol ID
- H24110
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pairing tVNS With Motor Skill Training in Older Adults
- ClinicalTrials.gov ID
- NCT06323954
- Acronym / sponsor ID
- H24110
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Florida
- Study start
- 27 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tVNS stimulation | Experimental | Procedure: tVNS stimulationBrief 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. |
| Sham stimulation | Sham comparator | Procedure: Sham stimulationBrief electrical current will be applied to the non-vagus nerve area (the earlobe) immediately after successful trials during finger control training. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65-84 years old across all races, genders, and ethnicities.
- Physically and cognitively healthy
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tVNS stimulationElectrical stimulation to the vagus nerve area. | Procedure or surgery | tVNS stimulation |
| Sham stimulationElectrical stimulation to the non-vagus nerve area. | Procedure or surgery | Sham stimulation |
Primary outcome
Rate of error reduction
Time frame: 2 weeks
The slope of the reduction in the root mean square error of finger force
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minoru Shinohara, PhD principal investigator
Georgia Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tVNS stimulation in people with Older Adults, run by Georgia Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minoru Shinohara, PhD (4048941030, shinohara@gatech.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of error reduction (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.