- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00424216
Direct Current Brain Polarization of the Frontal Lobes
Direct Current Brain Polarization of Bilateral Prefrontal Cortex
This study will explore what effects, if any, direct current (DC) brain polarization may produce on mental processes, such as attention, reaction time, working memory, speed of information processing and mood or emotional states. In DC brain polarization, a very weak electrical current is applied to the head. This technique has been used for many years on patients and healthy people with no known serious side effects. Studies have shown that DC polarization can temporarily improve people's ability to think of certain words. To determine if DC polarization can be used as a treatment for certain types of brain disorders, its possible effects on mood and other mental abilities must be determined.
Healthy normal volunteers over age 18 may be eligible for this study.
In each of three 1.5-hour sessions scheduled a day apart, participants complete the tasks listed below to determine the effects of polarization. For each session, electrodes are placed on the head, arm, and hand. One set of electrodes is for brain stimulation; the second set is used to measure the amount of skin moisture on the hand. The participants' tasks are to:
- Push a button on a keyboard when they see a specific item.
- Circle a number or make a mark on a line to indicate how much they feel a particular emotion or sensation at that time.
- Answer questions about themselves, or their opinions on certain topics.
- Look at several pictures and say how emotional they think they are.
- Read about an imaginary situation and say what they would do in that situation.
- Choose between decks of cards to try to win money.
- Compare the angles of lines.
- Identify smells, using a scratch and sniff test.
- At the end of the session, say how they are feeling.
Participants are called by phone on the day after each session to see how they are feeling.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Healthy volunteers over age 18. Pregnant women are eligible.
EXCLUSION CRITERIA:
Presence of metal in the cranial cavity or any holes in the skull due to trauma or surgery.
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.
Broken skin in the area of the electrodes.
Any history of a neurological or psychiatric disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Measure significant changes in psychomotor and cognitive function with the CalCAP battery or adverse changes in mood as measured by the Profile of Mood States.
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Secondary Outcome Measures
Outcome Measure |
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Screen for other cognitive, emotional, and perceptual changes using standardized and validated neuropsychological tests.
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Bechara A, Tranel D, Damasio H, Damasio AR. Failure to respond autonomically to anticipated future outcomes following damage to prefrontal cortex. Cereb Cortex. 1996 Mar-Apr;6(2):215-25. doi: 10.1093/cercor/6.2.215.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 070066
- 07-N-0066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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