Clinical trial NCT06561165: Multifocal HD-tDCS and Motor Function
Official title: Personalizing Multifocal Transcranial Direct Stimulation Dose to Target the Motor Network in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Functional Magnetic Resonance Imaging (fMRI)
High-density transcranial direct current stimulation
manual dexterity
Non-invasive brain stimulation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized and counterbalanced to arm 1 or arm 2.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent change in precision force-tracking task
timeFrame: Baseline and 24 hours after the third sessions are completed
measure: Percentage change in the time to complete the nine-hole peg test (9-HPT)
timeFrame: Baseline and 24 hours after the third sessions are completed
Secondary outcomes:
measure: Percentage change in the mean choice reaction time
timeFrame: Baseline and 24 hours after the third sessions are completed
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michael Vesia, PhD
role: PRINCIPAL_INVESTIGATOR
References: