Effect of Direct Current Polarization on Brain Function
Measuring the Brain Effects of DC Polarization With O-15 PET
2 other identifiers
observational
20
1 country
1
Brief Summary
This study will test a new electrical technique called direct current (DC) polarization that is able to change brain activity in subtle ways for a short time. A recent study showed that, depending on its direction, the current could make people perform a little better or perhaps slightly worse on a test of the function of the brain's frontal lobe. This study will use positron emission tomography (PET) scanning to examine how DC polarization affects brain activity. Healthy volunteers between 20 and 70 years of age who are right handed and who are not taking any medications that affect the brain may be eligible for this study. Candidates are screened with a brief medical history and neurological evaluation. Participants have a PET scan on three different days at least 3 days apart. Each scanning session takes 2-1/2 to 3 hours. For the scan, radioactive water is injected into the body through a vein. Subjects lie on a bed that slides in and out of the doughnut-shaped scanner, with their head held from the back by a padded holder and in front by a custom-molded plastic mask with holes for the eyes, nose, and mouth. DC electrodes made of wet sponges are placed on the right side of the head and over the left eye and are held in place with elastic bandages. Three kinds of DC polarization are tested. In two tests the current is the same, but in opposite directions. The third is a sham (placebo) condition with no current delivered. Each of the three scans is separated by at least 3 days. On each day, a series of scans is done in a single session. Before each injection of tracer, the DC current is turned on. This may cause a tingling or slight burning on the skin under the electrodes, which disappears when the current is turned off. In each session, the subject receives 16 injections of tracer about 8 minutes apart, with DC polarization turned on for 4 out of the 8 minutes. During most of the 8-minute periods, subjects are shown a pattern of dots about every 2 seconds. Sometimes the subject just looks at the patterns, and sometimes subjects are asked to push a button corresponding to the pattern they saw just before the current one. Sometimes they will be asked to push a button corresponding to the pattern that came before that one and so on, up to three patterns before the current one. The task lasts for about 2 minutes each time, with time to relax in between.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 29, 2004
CompletedFirst Posted
Study publicly available on registry
July 30, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedMarch 4, 2008
June 1, 2006
July 29, 2004
March 3, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Participants will be right-handed volunteers, aged 20 to 70, without history of any disorder of the central nervous system.
You may not qualify if:
- Current serious medical or psychiatric condition of any kind.
- History of any significant trauma or medical condition affecting the brain or skull.
- History of epileptic seizure.
- Current use of neuroactive medications, medications affecting the cerebral circulation, or recreational drugs.
- Presence of metal in the head (other than dental hardware) or body, such as pacemakers, aneurysm clips, metallic prostheses (including heart valves or cochlear implants), patches with metallic foil backing, such as nicotine patches, permanent eyeliner or shrapnel fragments.
- History of welding or metal work.
- Broken skin in the area of the stimulating electrodes.
- Pregnancy/breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892, United States
Related Publications (3)
Antal A, Kincses TZ, Nitsche MA, Paulus W. Modulation of moving phosphene thresholds by transcranial direct current stimulation of V1 in human. Neuropsychologia. 2003;41(13):1802-7. doi: 10.1016/s0028-3932(03)00181-7.
PMID: 14527543BACKGROUNDAntal A, Kincses TZ, Nitsche MA, Paulus W. Manipulation of phosphene thresholds by transcranial direct current stimulation in man. Exp Brain Res. 2003 Jun;150(3):375-8. doi: 10.1007/s00221-003-1459-8. Epub 2003 Apr 16.
PMID: 12698316BACKGROUNDAntal A, Kincses TZ, Nitsche MA, Bartfai O, Paulus W. Excitability changes induced in the human primary visual cortex by transcranial direct current stimulation: direct electrophysiological evidence. Invest Ophthalmol Vis Sci. 2004 Feb;45(2):702-7. doi: 10.1167/iovs.03-0688.
PMID: 14744917BACKGROUND
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 29, 2004
First Posted
July 30, 2004
Study Start
July 1, 2004
Study Completion
June 1, 2006
Last Updated
March 4, 2008
Record last verified: 2006-06