NCT00424216

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2008

Completed
Last Updated

July 2, 2017

Status Verified

December 23, 2008

First QC Date

January 17, 2007

Last Update Submit

June 30, 2017

Conditions

Healthy

Keywords

MoodEmotionJudgmentCortexBrain StimulationHealthy VolunteerHV

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Screen for other cognitive, emotional, and perceptual changes using standardized and validated neuropsychological tests.

Interventions

DC PolarizationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers over age 18. Pregnant women are eligible.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 8670652BACKGROUND

  • 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: 13968314BACKGROUND

  • 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: 13882165BACKGROUND

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

January 17, 2007

First Posted

January 18, 2007

Study Start

January 11, 2007

Study Completion

December 23, 2008

Last Updated

July 2, 2017

Record last verified: 2008-12-23

Locations

US(1)