- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06561165
Multifocal HD-tDCS and Motor Function
Personalizing Multifocal Transcranial Direct Stimulation Dose to Target the Motor Network in Older Adults
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael Vesia, PhD
- Phone Number: 734-764-5237
- Email: mvesia@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Michael Vesia, PhD
- Phone Number: 734-764-5237
- Email: mvesia@umich.edu
-
Principal Investigator:
- Michael Vesia, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HD-tDCS with standard intervention
Participants will have three daily sessions.
|
Participants will have three sessions along with behavioral assessments.
Participants will have an MRI before or after having HD-tDCS intervention.
|
|
Experimental: Personalized dose-controlled multifocal network-targeted HD-tDCS.
Participants will have three daily sessions.
|
Participants will have an MRI before or after having HD-tDCS intervention.
Participants will have three sessions along with behavioral assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent change in precision force-tracking task
Time Frame: 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).
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage change in the mean choice reaction time
Time Frame: 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
|
Baseline and 24 hours after the third sessions are completed
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Vesia, PhD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00250171
- 5P2CHD086844-10 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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