Protocol Number: 09-N-0196

Title:

High-Density Direct Current Brain Polarization

Number:

09-N-0196

Summary:

Background:

- Direct current (DC) brain polarization is a technique in which very weak electricity is applied to the head. Doctors have used DC polarization for many years on patients and healthy people with no known serious side effects. Earlier, researchers found that DC polarization can temporarily improve the ability of healthy people to think of certain words.

- A disadvantage of existing methods of DC polarization is that they use large electrodes and the current spreads over a large area of the brain. This makes it difficult to target particular brain areas. High-density DC polarization uses several small electrodes to focus the current in a small area of the brain. This study will test high-density DC polarization for the first time in humans.

Objectives:

- To see how well high-density direct current polarization works in the brain.

- To test a new method of performing direct current brain polarization.

Eligibility:

- Healthy, right-handed adults, ages 18 and older, who have no history of neurological or psychiatric illnesses.

Design:

- After an initial screening visit with clinical examination, participants may be assigned to one or both experiments of the study.

- Experiment 1: Participants will have electrodes placed on the left side of their heads, and will be asked to say aloud as many words as they can think of that begin with certain letters. After the high-density DC polarization current is turned on and run for 10 minutes, participants will say words beginning with a different set of letters and perform reaction time and thinking speed tests. Some participants will receive real polarization and others will not, although all participants will be told that they are receiving the polarization.

- Experiment 2: Participants will have DC brain polarization performed with transcranial magnetic stimulation (TMS), which uses magnetic pulses to activate nerve cells in the brain. We will use TMS to help us understand how far the effect of DC polarization spreads in the brain. After attaching electrodes to a point on the scalp above the ear, researchers will give about 50 TMS pulses to five different places near this area. These pulses will produce some painless muscle twitches in the hand or arm. The TMS pulses will be followed by the DC brain polarization, and then by another set of TMS pulses to see if there are any differences in muscle response.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Healthy volunteers over age 18

EXCLUSION CRITERIA:

Any history of central nervous system illness or behavioral disorder

Broken skin or other lesions in the area of the electrodes

Uncontrolled medical problems, such as diabetes mellitius, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that posses a risk for the subject during participation or potentially worsen the outcome of a burn

Presence of metal in the cranial cavity

Holes in the skull made by trauma or surgery

Pacemakers, medication pumps, and other implanted electronic hardware

Pregnancy (female volunteers who have the potential to become pregnant will have urine pregnancy test performed within 24 hours or participation)

Left handers will be excluded from Experiment 1

Special Instructions:

Currently Not Provided

Keywords:

Cerebral Cortex

Cognition

Motor Cortex

Cognitive Enhancement

Prefrontal Cortex

Recruitment Keyword(s):

Healthy Volunteer

Condition(s):

Healthy Volunteer

HV

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Device: DC Brain Polarization

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Bikson M, Radman T, Datta A. Rational modulation of neuronal processing with applied electric fields. Conf Proc IEEE Eng Med Biol Soc. 2006;1:1616-9.

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.

Creutzfeldt OD, Fromm GH, Kapp H. Influence of transcortical d-c currents on cortical neuronal activity. Exp Neurol. 1962 Jun;5:436-52.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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