HealthyNCT06561165
Multifocal HD-tDCS and Motor Function
A study testing Standard HD-tDCS intervention, Multifocal network targeted HD-tDCS intervention and Functional Magnetic Resonance Imaging (fMRI) in people with Healthy, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to understand how the brain controls movement and how Non-invasive Brain Stimulation (NIBS) with a technique called High-density transcranial direct current stimulation (HD-tDCS) can alter brain processes to improve behavior. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Standard HD-tDCS intervention, Multifocal network targeted HD-tDCS intervention and Functional Magnetic Resonance Imaging (fMRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 25 Jan 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 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants should be in good health with normal or corrected-to-normal visual acuity
- Right handed
- No history of neurological disorder
- English speaker
- Able to provide written consent prior to admission
Who cannot join
- Left-handed
- Participants are pregnant, suspect pregnancy or are attempting to become pregnant
- Have a pacemaker, intracardiac lines or any other medically implanted device or medicine pump
- Have cochlear hearing implants
- Taking drugs known to influence neural receptors that facilitate neuroplasticity (see protocol)
- Have non removable body piercings or have foreign objects in body
Show all 23Show fewer
- Have metal anywhere in the head that could increase risk of serious injury (not including braces, dental fillings, etc.) (see protocol)
- Have a personal or family history of seizure/epilepsy
- Taking prescription drugs that lower the threshold for seizures
- Recent history of excessive alcohol consumption
- History of alcohol addiction/dependence
- Recent history of recreational drug use
- History of drug addiction/dependence
- Recent history of recreational drug use
- History of drug addiction/dependence
- Diagnosed with a stroke, brain hemorrhage, brain tumor, encephalitis.
- Diagnosed with multiple sclerosis
- Diagnosed with Parkinson's disease or Alzheimer's disease
- Diagnosed with depression in the past 6 months
- Diagnosed with attention deficit disorder, schizophrenia, manic depressive (bipolar) disorder
- Diagnosed with normal pressure hydrocephalus or increased intra-cranial pressure
- Diabetes requiring insulin treatment
- Any serious heart disorder or liver disease
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
University of Michigan
Ann Arbor, Michigan, 48109
Michael Vesia, PhD, 734-764-5237, mvesia@umich.edu
Michael Vesia, PhD
About this study
Official title: Personalizing Multifocal Transcranial Direct Stimulation Dose to Target the Motor Network in Older Adults
The purpose of this study is to understand how the brain controls movement and how Non-invasive Brain Stimulation (NIBS) with a technique called High-density transcranial direct current stimulation (HD-tDCS) can alter brain processes to improve behavior. Participants in this study will be randomized to either HD-tDCS with standard intervention or personalized dose-controlled multifocal network-targeted HD-tDCS.
The hypothesis is that dexterous hand function will improve after a standard HD-tDCS dose and increase even more after personalized dose-controlled multifocal network-targeted HD-tDCS.
Read the detailed description
This project is the first of two projects. The second project will be registered as a separate project in the future and enroll participants from this project.
- Conditions
- Healthy
- Being tested
- Standard HD-tDCS intervention, Multifocal network targeted HD-tDCS intervention, Functional Magnetic Resonance Imaging (fMRI)
- Keywords
- Functional Magnetic Resonance Imaging (fMRI), High-density transcranial direct current stimulation, manual dexterity, Non-invasive brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard HD-tDCS interventionDevice
Participants will have three sessions along with behavioral assessments.
Multifocal network targeted HD-tDCS interventionDevice
Participants will have three sessions along with behavioral assessments.
Functional Magnetic Resonance Imaging (fMRI)Device
Participants will have an MRI before or after having HD-tDCS intervention.
| Study group | Role | What they receive |
|---|---|---|
| HD-tDCS with standard intervention | Experimental | Participants will have three daily sessions. Receives: Device: Standard HD-tDCS intervention; Device: Functional Magnetic Resonance Imaging (fMRI) |
| Personalized dose-controlled multifocal network-targeted HD-tDCS. | Experimental | Participants will have three daily sessions. Receives: Device: Multifocal network targeted HD-tDCS intervention; Device: Functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in precision force-tracking task
Squared distance (error) from the cursor to the target in precision force-tracking task, estimated as the root mean squared error (RMSE).
Measured: Baseline and 24 hours after the third sessions are completed
Percentage change in the time to complete the nine-hole peg test (9-HPT)
9-hole peg test is a manual dexterity measure, estimated as the time required to complete the task (seconds).
Measured: Baseline and 24 hours after the third sessions are completed
Secondary outcomes (1)
Percentage change in the mean choice reaction time
Mean reaction time for subjects responding in the 2-choice reaction time control task, for correct responses
Measured: Baseline and 24 hours after the third sessions are completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start25 Feb 2025
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomized and counterbalanced to arm 1 or arm 2.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michael Vesia, PhD, University of Michigan
- Investigators
- Michael Vesia, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561165
- Sponsor's protocol ID
- HUM00250171
- Other IDs
- 5P2CHD086844-10
- Status last verified
- Feb 2026
- First submitted
- 16 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Multifocal Transcranial Direct Stimulation Dose to Target the Motor Network in Older Adults
- ClinicalTrials.gov ID
- NCT06561165
- Acronym / sponsor ID
- HUM00250171
- Conditions
- Healthy
- Keywords
- Functional Magnetic Resonance Imaging (fMRI), High-density transcranial direct current stimulation, manual dexterity, Non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 19 Aug 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 purpose of this study is to understand how the brain controls movement and how Non-invasive Brain Stimulation (NIBS) with a technique called High-density transcranial direct current stimulation (HD-tDCS) can alter brain processes to improve behavior. Participants in this study will be randomized to either HD-tDCS with standard intervention or personalized dose-controlled multifocal network-targeted HD-tDCS.
The hypothesis is that dexterous hand function will improve after a standard HD-tDCS dose and increase even more after personalized dose-controlled multifocal network-targeted HD-tDCS.
Detailed description
This project is the first of two projects. The second project will be registered as a separate project in the future and enroll participants from this project.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized and counterbalanced to arm 1 or arm 2.
| Arm | Type | Receives |
|---|---|---|
| HD-tDCS with standard intervention | Experimental | Device: Standard HD-tDCS intervention, Device: Functional Magnetic Resonance Imaging (fMRI)Participants will have three daily sessions. |
| Personalized dose-controlled multifocal network-targeted HD-tDCS. | Experimental | Device: Multifocal network targeted HD-tDCS intervention, Device: Functional Magnetic Resonance Imaging (fMRI)Participants will have three daily sessions. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Participants should be in good health with normal or corrected-to-normal visual acuity
- Right handed
- No history of neurological disorder
- English speaker
- Able to provide written consent prior to admission
Key exclusion criteria (23 listed)
- Left-handed
- Participants are pregnant, suspect pregnancy or are attempting to become pregnant
- Have a pacemaker, intracardiac lines or any other medically implanted device or medicine pump
- Have cochlear hearing implants
- Taking drugs known to influence neural receptors that facilitate neuroplasticity (see protocol)
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 |
|---|---|---|
| Standard HD-tDCS interventionParticipants will have three sessions along with behavioral assessments. | Device | HD-tDCS with standard intervention |
| Multifocal network targeted HD-tDCS interventionParticipants will have three sessions along with behavioral assessments. | Device | Personalized dose-controlled multifocal network-targeted HD-tDCS. |
| Functional Magnetic Resonance Imaging (fMRI)Participants will have an MRI before or after having HD-tDCS intervention. | Device | HD-tDCS with standard intervention, Personalized dose-controlled multifocal network-targeted HD-tDCS. |
Primary outcome
Percent change in precision force-tracking task
Time frame: Baseline and 24 hours after the third sessions are completed
Squared distance (error) from the cursor to the target in precision force-tracking task, estimated as the root mean squared error (RMSE).
Percentage change in the time to complete the nine-hole peg test (9-HPT)
Time frame: Baseline and 24 hours after the third sessions are completed
9-hole peg test is a manual dexterity measure, estimated as the time required to complete the task (seconds).
1 secondary outcome
Percentage change in the mean choice reaction time
Time frame: Baseline and 24 hours after the third sessions are completed
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Michael Vesia, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard HD-tDCS intervention, Multifocal network targeted HD-tDCS intervention and Functional Magnetic Resonance Imaging (fMRI) in people with Healthy, run by University of Michigan 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 5 inclusion and 23 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 20 Oct 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. 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 Michael Vesia, PhD (734-764-5237, mvesia@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in precision force-tracking task (time frame: Baseline and 24 hours after the third sessions are completed). The study lists 2 primary outcomes in all. 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 20 Oct 2026.