Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00471107
Status:
COMPLETED
Last Update Posted:
2016-03-24
First Post:
2007-05-08
Brief Title:
Effect of Electrical Stimulation DC Polarization to the Brain on Memory
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of Direct Current Brain Polarization on Verbal Memory
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 subjects 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
Read a list of words and remember them Later they will try to repeat the words from memory
Look at a series of designs and remember them Later they will try to draw the designs from memory
Push a button on a keyboard when they see a specific item for example when the number 7 appears
Generate as many words as they can think of that begin with a particular letter of the alphabet
Subjects may be videotaped for some or all of the time during the sessions
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 subjects 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
Read a list of words and remember them Later they will try to repeat the words from memory
Look at a series of designs and remember them Later they will try to draw the designs from memory
Push a button on a keyboard when they see a specific item for example when the number 7 appears
Generate as many words as they can think of that begin with a particular letter of the alphabet
Subjects may be videotaped for some or all of the time during the sessions
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-N-0147 | None | None | None |