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| ID | Type | Description | Link |
|---|---|---|---|
| P2CHD086844 | U.S. NIH Grant/Contract | View source |
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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.
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham stimulation | Sham Comparator |
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| Individualized stimulation | Experimental |
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| 2mA stimulation | Experimental |
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| 4mA stimulation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham transcranial direct current stimulation | Device | Participants will receive 30 seconds of ramp up and down stimulation at the start and end of the 20 minute stimulation period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S George, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2023 | Dec 15, 2023 | ICF_000.pdf |
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| Individualized transcranial direct current stimulation | Device | Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at the individualized dose (maximum of 4mA). |
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| 2mA transcranial direct current stimulation | Device | Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 2mA dose. |
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| 4mA transcranial direct current stimulation | Device | Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 4mA dose. |
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