Multifocal HD-tDCS and Motor Function

University of Michigan

Status: Not yet enrolling

Conditions: Healthy

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06561165

HUM00250171

5P2CHD086844-10 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

HD-tDCS with standard intervention

Experimental group

Description:

Participants will have three daily sessions.

Treatment:

Device: Functional Magnetic Resonance Imaging (fMRI)

Device: Standard HD-tDCS intervention

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

Experimental group

Description:

Participants will have three daily sessions.

Treatment:

Device: Multifocal network targeted HD-tDCS intervention

Device: Functional Magnetic Resonance Imaging (fMRI)