Study Stopped
We currently do not have the time to pursue this research given other ongoing projects. If we restart this project, we will submit a new ClinicalTrials record for the protocol. Thank you.
Individualizing tDCS Dose
Testing the Effects of Individualized and 4mA tDCS
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
Transcranial direct current stimulation (tDCS) is a noninvasive method of modulating brain activity and has therapeutic potential in many neurological and psychiatric conditions. However, unlike every current FDA-approved form of brain stimulation, there is no method of individualizing stimulation dose. In this study, a method of individualizing tDCS dose on behavioral outcomes and whether this could help to improve the consistency and magnitude of the stimulation effects will be tested.
Trial Health
Trial Health Score
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Started Dec 2024
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2021
CompletedStudy Start
First participant enrolled
December 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2024
CompletedNovember 6, 2025
November 1, 2025
Same day
February 2, 2021
November 4, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Motor Evoked Potential Variance
MEP variance is measured by single pulses of transcranial magnetic stimulation and contralateral hand electrodes.
Baseline and post-stimulation (20 minutes apart)
Difference in Motor Evoked Potential Amplitudes from 4mA and 2mA Stimulation
MEP amplitude is measured by single pulses of transcranial magnetic stimulation and contralateral hand electrodes.
Baseline and post-stimulation (20 minutes apart)
Study Arms (4)
Sham stimulation
SHAM COMPARATORIndividualized stimulation
EXPERIMENTAL2mA stimulation
EXPERIMENTAL4mA stimulation
EXPERIMENTALInterventions
Participants will receive 30 seconds of ramp up and down stimulation at the start and end of the 20 minute stimulation period.
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at the individualized dose (maximum of 4mA).
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 2mA dose.
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 4mA dose.
Eligibility Criteria
You may qualify if:
- Healthy volunteers or chronic stroke participants (at least 6 months prior to the study)
- No history of epilepsy
- No metal in the body
- No contraindications for TMS or MRI scanning
- Right handed
- Ability to find motor hotspot and acquire motor evoked potentials
You may not qualify if:
- Metal in the body
- History of epilepsy or claustrophobia
- Alcohol or substance abuse or dependence
- Current treatment for any psychiatric conditions (pharmacological or otherwise)
- Pregnant or actively breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Mark S George, MD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor-Faculty
Study Record Dates
First Submitted
February 2, 2021
First Posted
February 8, 2021
Study Start
December 2, 2024
Primary Completion
December 2, 2024
Study Completion
December 2, 2024
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share