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Recruiting NCT06561165

Multifocal HD-tDCS and Motor Function

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard HD-tDCS intervention, Multifocal network targeted HD-tDCS intervention, Functional Magnetic Resonance Imaging (fMRI).
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 65 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Personalizing Multifocal Transcranial Direct Stimulation Dose to Target the Motor Network in Older Adults

Overview

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.

Interventions

  • Device Standard HD-tDCS intervention
    Participants will have three sessions along with behavioral assessments.
  • Device Multifocal network targeted HD-tDCS intervention
    Participants will have three sessions along with behavioral assessments.
  • Device Functional Magnetic Resonance Imaging (fMRI)
    Participants will have an MRI before or after having HD-tDCS intervention.

Primary outcome measures

  • Percent change in precision force-tracking task [Time frame: Baseline and 24 hours after the third sessions are completed]
  • Percentage change in the time to complete the nine-hole peg test (9-HPT) [Time frame: Baseline and 24 hours after the third sessions are completed]
Secondary outcome measures (1)
  • Percentage change in the mean choice reaction time [Time frame: Baseline and 24 hours after the third sessions are completed]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT06561165 · HUM00250171 · 5P2CHD086844-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗