Individualizing tDCS Dose

November 4, 2025 updated by: Kevin Caulfield, Medical University of South Carolina

Testing the Effects of Individualized and 4mA tDCS

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham stimulation
Device: Sham transcranial direct current stimulation
Participants will receive 30 seconds of ramp up and down stimulation at the start and end of the 20 minute stimulation period.
Experimental: Individualized stimulation
Device: Individualized transcranial direct current stimulation
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at the individualized dose (maximum of 4mA).
Experimental: 2mA stimulation
Device: 2mA transcranial direct current stimulation
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 2mA dose.
Experimental: 4mA stimulation
Device: 4mA transcranial direct current stimulation
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 4mA dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Motor Evoked Potential Variance
Time Frame: Baseline and post-stimulation (20 minutes apart)
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
Time Frame: Baseline and post-stimulation (20 minutes apart)
MEP amplitude is measured by single pulses of transcranial magnetic stimulation and contralateral hand electrodes.
Baseline and post-stimulation (20 minutes apart)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Mark S George, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Actual)

December 2, 2024

Study Completion (Actual)

December 2, 2024

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Estimated)

November 6, 2025

Last Update Submitted That Met QC Criteria

November 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 00104712
  • P2CHD086844 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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