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
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
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- 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