A Phase 1/2 interventional study of DC brain polarization in Healthy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-24.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Phase 1/2, Interventional, and Treatment
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.
National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 592 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Device: DC brain polarization
0.08 mA/cm2
Device: DC brain polarization
0.08 mA/cm2
Device: DC brain polarization
0.08 mA/cm2
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).
Time frame: 24 hours
Healthy subjects were recruited through the NIH Clinical Research Volunteer Program
| Milestone | Anodal TDCS | Cathodal TDCS | Sham TDCS |
|---|---|---|---|
| Started | 15 | 15 | 15 |
| Completed | 12 | 14 | 12 |
| Not completed | 3 | 1 | 3 |
| Withdrew: Technical problems/data loss | 3 | 1 | 3 |
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).
| Words recalled | Left Prefrontal Anodal TDCS | Left Prefrontal Cathodal TDCS | Sham TDCS |
|---|---|---|---|
| Verbal Memory | 8.625 ± 1.768 | 9 ± 1.604 | 8 ± 2.828 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anodal TDCS | — | 1/12 (8.3%) | 0/12 (0%) |
| Cathodal TDCS | — | 0/14 (0%) | 0/14 (0%) |
| Sham TDCS | — | 0/12 (0%) | 0/12 (0%) |
| Event | Anodal TDCS | Cathodal TDCS | Sham TDCS |
|---|---|---|---|
| BurnSkin and subcutaneous tissue disorders | 1/12 | 0/14 | 0/12 |
| Age, Continuous(years) | Anodal TDCS | Cathodal TDCS | Sham TDCS | Total |
|---|---|---|---|---|
| Mean | 26.5 ± 8.06 | 32.4 ± 14.05 | 32.5 ± 11.29 | 30.57 ± 11.60 |
| Sex: Female, Male(Participants) | Anodal TDCS | Cathodal TDCS | Sham TDCS | Total |
|---|---|---|---|---|
| Female | 5 | 6 | 8 | 19 |
| Male | 7 | 8 | 4 | 19 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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National Institute of Neurological Disorders and Stroke (NINDS)