Multifocal HD-tDCS and Motor Function

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Device: Multifocal network targeted HD-tDCS intervention; Device: Standard HD-tDCS intervention; Device: Functional Magnetic Resonance Imaging (fMRI)

• Registration Number: NCT06561165
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-19
• Study Start: 2025-02-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized dose-controlled multifocal network-targeted HD-tDCS.	Multifocal network targeted HD-tDCS intervention	Participants will have three daily sessions.
Personalized dose-controlled multifocal network-targeted HD-tDCS.	Functional Magnetic Resonance Imaging (fMRI)	Participants will have three daily sessions.
HD-tDCS with standard intervention	Standard HD-tDCS intervention	Participants will have three daily sessions.
HD-tDCS with standard intervention	Functional Magnetic Resonance Imaging (fMRI)	Participants will have three daily sessions.

Primary Outcome Measures

Name	Time	Method
Percentage change in the time to complete the nine-hole peg test (9-HPT)	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).
Percent change in precision force-tracking task	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).

Secondary Outcome Measures

Name	Time	Method
Percentage change in the mean choice reaction time	Baseline and 24 hours after the third sessions are completed	Mean reaction time for subjects responding in the 2-choice reaction time control task, for correct responses

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States