High-Density Direct Current Brain Polarization

NCT00944931 | Completed Phase 1

• 2 other identifiers: 09019609-N-0196
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer; HV

Keywords

Cerebral Cortex; Cognition; Motor Cortex; Cognitive Enhancement; Prefrontal Cortex; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Verbal fluency; focality of effect on MEP (exploratory)

Interventions

DC Brain Polarization DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers over age 18

You may not qualify if:

• 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 mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses 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 of participation)
• Left handers will be excluded from Experiment 1

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bikson M, Radman T, Datta A. Rational modulation of neuronal processing with applied electric fields. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:1616-9. doi: 10.1109/IEMBS.2006.259548.

  PMID: 17946911 BACKGROUND

• 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.

  PMID: 13968314 BACKGROUND

• 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.

  PMID: 13882165 BACKGROUND

Study Officials

• William H Theodore, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: July 20, 2009
• Primary Completion: April 5, 2011
• Study Completion: April 5, 2011
• Last Updated: July 2, 2017

Record last verified: 2012-02-09

Locations

US (1)