Multifocal HD-tDCS and Motor Function

NCT ID: NCT06561165

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2026-01-25

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized and counterbalanced to arm 1 or arm 2.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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HD-tDCS with standard intervention

Participants will have three daily sessions.

Group Type EXPERIMENTAL

Standard HD-tDCS intervention

Intervention Type DEVICE

Participants will have three sessions along with behavioral assessments.

Functional Magnetic Resonance Imaging (fMRI)

Intervention Type DEVICE

Participants will have an MRI before or after having HD-tDCS intervention.

Personalized dose-controlled multifocal network-targeted HD-tDCS.

Participants will have three daily sessions.

Group Type EXPERIMENTAL

Multifocal network targeted HD-tDCS intervention

Intervention Type DEVICE

Participants will have three sessions along with behavioral assessments.

Functional Magnetic Resonance Imaging (fMRI)

Intervention Type DEVICE

Participants will have an MRI before or after having HD-tDCS intervention.

Interventions

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Standard HD-tDCS intervention

Participants will have three sessions along with behavioral assessments.

Intervention Type DEVICE

Multifocal network targeted HD-tDCS intervention

Participants will have three sessions along with behavioral assessments.

Intervention Type DEVICE

Functional Magnetic Resonance Imaging (fMRI)

Participants will have an MRI before or after having HD-tDCS intervention.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Michael Vesia, PhD

Assistant Professor of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Vesia, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Vesia, PhD

Role: CONTACT

734-764-5237

Facility Contacts

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Michael Vesia, PhD

Role: primary

734-764-5237

Other Identifiers

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5P2CHD086844-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00250171

Identifier Type: -

Identifier Source: org_study_id

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