Multifocal HD-tDCS and Motor Function

NCT06561165 | Recruiting FDA Device

• 2 other identifiers: HUM002501715P2CHD086844-10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Keywords

Functional Magnetic Resonance Imaging (fMRI); High-density transcranial direct current stimulation; manual dexterity; Non-invasive brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline and 24 hours after the third sessions are completed

Secondary Outcomes (1)

• Percentage change in the mean choice reaction time

  Baseline and 24 hours after the third sessions are completed

Study Arms (2)

HD-tDCS with standard intervention

EXPERIMENTAL

Participants will have three daily sessions.

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.

Device: Multifocal network targeted HD-tDCS intervention; Device: Functional Magnetic Resonance Imaging (fMRI)

Interventions

Standard HD-tDCS intervention DEVICE

Participants will have three sessions along with behavioral assessments.

HD-tDCS with standard intervention

Multifocal network targeted HD-tDCS intervention DEVICE

Participants will have three sessions along with behavioral assessments.

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

Functional Magnetic Resonance Imaging (fMRI) DEVICE

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

HD-tDCS with standard intervention; Personalized dose-controlled multifocal network-targeted HD-tDCS.

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Medical University of South Carolina: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Michael Vesia, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Vesia, PhD

CONTACT

734-764-5237; mvesia@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Kinesiology

Model Details: Participants will be randomized and counterbalanced to arm 1 or arm 2.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 19, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): January 25, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)