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| ID | Type | Description | Link |
|---|---|---|---|
| 09-N-0196 |
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Background:
Objectives:
Eligibility:
- Healthy, right-handed adults, ages 18 and older, who have no history of neurological or psychiatric illnesses.
Design:
Objective:
The principal objectives are: 1) to explore the effectiveness of anodal high-density direct current (HDDC) stimulation of the brain; and 2) test the focality of the technique.
Study Population:
Up to 81 healthy volunteers over the age of 18 will be enrolled.
Design:
We will perform three studies:
Outcome Measures:
The primary outcome measures are the effect of anodal HDDC (relative to sham) on category verbal fluency, and the decay in the HDDC-induced change in corticospinal output excitability with distance from the active electrode. Performance on the California Computerized Assessment Package is included as a secondary safety outcome.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC Brain Polarization | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal fluency; focality of effect on MEP (exploratory) |
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Healthy volunteers over age 18
EXCLUSION CRITERIA:
Any history of central nervous system illness or behavioral disorder
Broken skin or other lesions in the area of the electrodes
Uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation or potentially worsen the outcome of a burn
Presence of metal in the cranial cavity
Holes in the skull made by trauma or surgery
Pacemakers, medication pumps, and other implanted electronic hardware
Pregnancy (female volunteers who have the potential to become pregnant will have urine pregnancy test performed within 24 hours of participation)
Left handers will be excluded from Experiment 1
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| Name | Affiliation | Role |
|---|---|---|
| William H Theodore, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17946911 | Background | Bikson M, Radman T, Datta A. Rational modulation of neuronal processing with applied electric fields. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:1616-9. doi: 10.1109/IEMBS.2006.259548. | |
| 13968314 | Background | BINDMAN LJ, LIPPOLD OC, REDFEARN JW. Long-lasting changes in the level of the electrical activity of the cerebral cortex produced bypolarizing currents. Nature. 1962 Nov 10;196:584-5. doi: 10.1038/196584a0. No abstract available. |
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| 13882165 | Background | CREUTZFELDT OD, FROMM GH, KAPP H. Influence of transcortical d-c currents on cortical neuronal activity. Exp Neurol. 1962 Jun;5:436-52. doi: 10.1016/0014-4886(62)90056-0. No abstract available. |