Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048698
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-11-05
Brief Title:
Effects of Direct Current Brain Stimulation on Cognition
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Trial of Focal DC Brain Polarization
Status:
COMPLETED
Status Verified Date:
2005-10
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 examine the effects of direct current DC electrical polarization of the brain on thinking speed reaction time mood and brain waves in healthy individuals The results will provide information for designing further studies to examine the safety and effectiveness of this technique in treating certain brain diseases involving impaired cognition thought processing The study consists of three experiments participants will take part in either one or two of the experiments
Healthy right-handed volunteers between 18 and 80 years of age with 12 or more years of education may be eligible for this study Candidates will be screened with a medical and educational history and a brief neurological examination Participants in experiments 2 and 3 will also be screened with a verbal fluency test in which they will be asked to say as many words beginning with certain letters as they can in 1 minute
Participants will undergo the following procedures for the experiments in which they participate
Experiment 1
While resting quietly subjects receive 20 minutes of weak electrical current stimulation or sham stimulation with no current For the stimulation two gauze pads soaked with a conducting salt solution are placed on the head-one on the left side and one above the right eye The current is passed between the pads and may cause an itching or tingling sensation under the electrodes Before and after the stimulation the participants reaction time-tested by moving a finger as fast as possible at the sound of a tone-and mood are evaluated Some participants also have an electroencephalogram or EEG brain wave recording during the experiment After the stimulation participants take two brief tests of thinking speed and the mood and reaction time tests are repeated
Experiment 2
The participant sits in a chair with electrodes attached to the muscles that control movement in a finger on the right hand Reaction time is tested as described in experiment 1 Then transcranial magnetic stimulation TMS is used to test the activity of the brains motor cortex the part of the brain that controls movement For TMS an insulated wire coil is placed on the subjects scalp A brief electrical current is passed through the coil creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the brain cortex The stimulation may cause twitching of the right hand or arm or produce a mild snapping sensation on the scalp During the stimulation the electrical activity of muscles in the right hand is recorded on a computer Following the TMS DC stimulation is applied as described in experiment 1 The stimulation begins at a low level and is followed by repeat TMS and DC stimulation at increasingly higher levels This continues until there is a clear effect on the muscle response to the magnetic pulses or until the stimulation becomes uncomfortable At the end of the electrical stimulation reaction time is tested again
Experiment 3
This experiment uses the average DC level that produced a change in the size of the responses to magnetic stimulation in experiment 2 Thinking speed and reaction time are tested during the DC stimulation and the mood test is given before and during the stimulation This test does not use TMS or EEG recording
Healthy right-handed volunteers between 18 and 80 years of age with 12 or more years of education may be eligible for this study Candidates will be screened with a medical and educational history and a brief neurological examination Participants in experiments 2 and 3 will also be screened with a verbal fluency test in which they will be asked to say as many words beginning with certain letters as they can in 1 minute
Participants will undergo the following procedures for the experiments in which they participate
Experiment 1
While resting quietly subjects receive 20 minutes of weak electrical current stimulation or sham stimulation with no current For the stimulation two gauze pads soaked with a conducting salt solution are placed on the head-one on the left side and one above the right eye The current is passed between the pads and may cause an itching or tingling sensation under the electrodes Before and after the stimulation the participants reaction time-tested by moving a finger as fast as possible at the sound of a tone-and mood are evaluated Some participants also have an electroencephalogram or EEG brain wave recording during the experiment After the stimulation participants take two brief tests of thinking speed and the mood and reaction time tests are repeated
Experiment 2
The participant sits in a chair with electrodes attached to the muscles that control movement in a finger on the right hand Reaction time is tested as described in experiment 1 Then transcranial magnetic stimulation TMS is used to test the activity of the brains motor cortex the part of the brain that controls movement For TMS an insulated wire coil is placed on the subjects scalp A brief electrical current is passed through the coil creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the brain cortex The stimulation may cause twitching of the right hand or arm or produce a mild snapping sensation on the scalp During the stimulation the electrical activity of muscles in the right hand is recorded on a computer Following the TMS DC stimulation is applied as described in experiment 1 The stimulation begins at a low level and is followed by repeat TMS and DC stimulation at increasingly higher levels This continues until there is a clear effect on the muscle response to the magnetic pulses or until the stimulation becomes uncomfortable At the end of the electrical stimulation reaction time is tested again
Experiment 3
This experiment uses the average DC level that produced a change in the size of the responses to magnetic stimulation in experiment 2 Thinking speed and reaction time are tested during the DC stimulation and the mood test is given before and during the stimulation This test does not use TMS or EEG recording
Detailed Description:
The passage of weak DC currents across the head DC polarization has been done for centuries with various effects reported Many of the reports and studies of DC effects in humans are however archaic anecdotal uncontrolled or scientifically baseless Recently it has been shown by objective means in controlled experiments that this type of treatment has robust and lasting effects on the excitability of the motor cortex in healthy humans In vitro and animal experiments have revealed little about the mechanism of this effect but neither has convincing evidence of toxicity been found at moderate doses Therefore we are becoming interested in whether this type of treatment can be used to improve cognitive processing in individuals with brain lesions particularly of the prefrontal cortex The purpose of this project is to prepare the way for clinical trials by beginning to establish the safety of this technique in humans and then to look for preliminary evidence of potentially useful effects on cognition when moderate doses are applied to the prefrontal cortex First we propose to test the safety of 20 min of anodal and cathodal DC applied the left prefrontal area at 1 mV by looking for clinical-level effects on verbal fluency cognitive processing speed EEG mood or motor reaction speed after exposure The duration of exposure in this study will match the time required to gather preliminary efficacy data in healthy controls and patients Then in a dose-finding study we propose to find the anodal DC amperage necessary for producing a clear effect on excitability as measured by an increase in the amplitude of the motor evoked potential to transcranial magnetic stimulation Then if no significant adverse effects are in the first two studies a preliminary efficacy study will look for differences in these measures between groups receiving anodal cathodal and sham DC of the left prefrontal cortex during stimulation
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 |
|---|---|---|---|
| 03-N-0017 | None | None | None |