tDCSNCT04742439
Individualizing tDCS Dose
A study testing Individualized transcranial direct current stimulation, 2mA transcranial direct current stimulation and 4mA transcranial direct current stimulation in people with tDCS and Motor Function, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- tDCS, Motor Function
- What is being tested?
- Individualized transcranial direct current stimulation, 2mA transcranial direct current stimulation and 4mA transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
- Conditions
- tDCS, Motor Function
- Being tested
- Sham transcranial direct current stimulation, Individualized transcranial direct current stimulation, 2mA transcranial direct current stimulation, 4mA transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham transcranial direct current stimulationDevice
Participants will receive 30 seconds of ramp up and down stimulation at the start and end of the 20 minute stimulation period.
Individualized transcranial direct current stimulationDevice
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at the individualized dose (maximum of 4mA).
2mA transcranial direct current stimulationDevice
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 2mA dose.
4mA transcranial direct current stimulationDevice
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 4mA dose.
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation | Sham comparator | Not described Receives: Device: Sham transcranial direct current stimulation |
| Individualized stimulation | Experimental | Not described Receives: Device: Individualized transcranial direct current stimulation |
| 2mA stimulation | Experimental | Not described Receives: Device: 2mA transcranial direct current stimulation |
| 4mA stimulation | Experimental | Not described Receives: Device: 4mA transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Motor Evoked Potential Variance
MEP variance is measured by single pulses of transcranial magnetic stimulation and contralateral hand electrodes.
Measured: 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.
Measured: Baseline and post-stimulation (20 minutes apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start2 Dec 2024
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for tDCSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kevin Caulfield, Medical University of South Carolina
- Investigators
- Mark S George, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742439
- Sponsor's protocol ID
- 00104712
- Other IDs
- P2CHD086844
- Status last verified
- Nov 2025
- First submitted
- 2 Feb 2021
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effects of Individualized and 4mA tDCS
- ClinicalTrials.gov ID
- NCT04742439
- Acronym / sponsor ID
- 00104712
- Conditions
- tDCS, Motor Function
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation | Sham comparator | Device: Sham transcranial direct current stimulation |
| Individualized stimulation | Experimental | Device: Individualized transcranial direct current stimulation |
| 2mA stimulation | Experimental | Device: 2mA transcranial direct current stimulation |
| 4mA stimulation | Experimental | Device: 4mA transcranial direct current stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham transcranial direct current stimulationParticipants will receive 30 seconds of ramp up and down stimulation at the start and end of the 20 minute stimulation period. | Device | Sham stimulation |
| Individualized transcranial direct current stimulationParticipants will receive 20 minutes of transcranial direct current stimulation (tDCS) at the individualized dose (maximum of 4mA). | Device | Individualized stimulation |
| 2mA transcranial direct current stimulationParticipants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 2mA dose. | Device | 2mA stimulation |
| 4mA transcranial direct current stimulationParticipants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 4mA dose. | Device | 4mA stimulation |
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S George, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized transcranial direct current stimulation, 2mA transcranial direct current stimulation and 4mA transcranial direct current stimulation in people with tDCS and Motor Function, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motor Evoked Potential Variance (time frame: Baseline and post-stimulation (20 minutes apart)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.