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| ID | Type | Description | Link |
|---|---|---|---|
| 07-N-0147 |
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This study will test the effect of direct current (DC) brain polarization (the application of a very weak electrical current to the brain) on learning and memory. Earlier studies have shown that DC polarization can temporarily improve the ability of healthy people to think of certain words. This study will explore whether it can also temporarily improve learning and memory.
Healthy people 18 years of age and older may be eligible for this study. Subjects participate in two experimental sessions at the NIH Clinical Center. The first session lasts about 1 hour; the second session, on the next day, takes about 10 minutes.
At the beginning of the first session, electrodes are placed on the subject's head and arm for brain stimulation. The current may be turned on for 25 minutes, or only very briefly (sham stimulation). Subjects are not told which type of stimulation they are receiving. No stimulation is applied in the second session.
During the sessions subjects are asked to complete the following tasks that will help elucidate the effects of polarization:
Subjects may be videotaped for some or all of the time during the sessions.
OBJECTIVE: The principal objective is to establish whether DC polarization of left lateral prefrontal cortex can enhance verbal memory.
STUDY POPULATION: 75 healthy volunteers over the age of 18 will be enrolled.
DESIGN: The study is a double-blind parallel study with three arms: anodal polarization, cathodal polarization, and sham treatment.
OUTCOME MEASURES: The primary outcome measure is performance on the WMS-III Word Lists test. Secondary outcome measures, testing for effects of DC polarization on basic information processing and non-verbal memory, respectively, are the CalCAP and WMS-III Visual Reproduction Test. The Verbal Fluency Test will be administered prior to stimulation and 24 hours post-stimulation to screen for other residual effects of the polarization on the stimulated region.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham TDCS | Sham Comparator |
| |
| Surface-anodal direct current | Experimental | 0.08 mA/cm2 |
|
| Surface-cathodal direct current | Active Comparator | 0.08 mA/cm2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC brain polarization | Device | 0.08 mA/cm2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Memory | The Wechsler Memory Scale (WMS-III) is a neuropsychological test designed to measure different memory functions. The WMS-III Word Lists is a measure of verbal learning ability. The examiner reads a list of 12 semantically unrelated words and the subject immediately recalls as many words as possible. For this study, the primary outcome is a measure of verbal recall performance at 24 hours following presentation of the words under three conditions, i.e., anodal tDCS, cathodal tDCS, and sham. Scores may range from 0 (no words recalled) to 12 (all words recalled). | 24 hours |
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Healthy volunteers over age 18. Pregnancy is not an exclusion.
EXCLUSION CRITERIA:
Any history of a central nervous system illness or other behavioral disorder.
Broken skin in the area of the electrodes.
Uncontrolled medical problems, such as diabetes mellitus, hypertension, airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.
Presence of metal in the cranial cavity.
Holes in the skull made by trauma or surgery.
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| 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 |
|---|---|---|---|
| 14977202 | Background | Herwig U, Satrapi P, Schonfeldt-Lecuona C. Using the international 10-20 EEG system for positioning of transcranial magnetic stimulation. Brain Topogr. 2003 Winter;16(2):95-9. doi: 10.1023/b:brat.0000006333.93597.9d. | |
| 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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Nothing to report
Healthy subjects were recruited through the NIH Clinical Research Volunteer Program
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| ID | Title | Description |
|---|---|---|
| FG000 | Anodal TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks. |
| FG001 | Cathodal TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks. |
| FG002 | Sham TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anodal TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks. |
| BG001 | Cathodal TDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Verbal Memory | The Wechsler Memory Scale (WMS-III) is a neuropsychological test designed to measure different memory functions. The WMS-III Word Lists is a measure of verbal learning ability. The examiner reads a list of 12 semantically unrelated words and the subject immediately recalls as many words as possible. For this study, the primary outcome is a measure of verbal recall performance at 24 hours following presentation of the words under three conditions, i.e., anodal tDCS, cathodal tDCS, and sham. Scores may range from 0 (no words recalled) to 12 (all words recalled). | All subjects in this group for whom data were obtained were analyzed | Posted | Mean | Standard Deviation | Words recalled | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anodal TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burn | Skin and subcutaneous tissue disorders | Punctate burn under reference electrode on arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Wassermann | NIH/NINDS | 301-496-0151 | wassermanne@ninds.nih.gov |
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| ID | Term |
|---|---|
| D007802 | Language |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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. |
Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
| BG002 | Sham TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Left Prefrontal Cathodal TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks. |
| OG002 | Sham TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks. |
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|
|
| 1 |
| 12 |
| 0 |
| 12 |
| EG001 | Cathodal TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks. | 0 | 14 | 0 | 14 |
| EG002 | Sham TDCS | Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks. | 0 | 12 | 0 | 12 |
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| D009422 |
| Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |