Direct Current Brain Polarization of the Frontal Lobes



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2007
End Date:December 2008

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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.

Objective: The principal objective is to establish the safety and feasibility of bilateral
direct current (DC) polarization of the frontal lobes, which may be a useful modality for
treatment of frontal lobe cognitive or behavioral deficits. Our secondary objective is to
gather preliminary data on whether DC can modulate cognitive and emotion-related functions
of the frontal lobes in healthy individuals. Study population: 25 healthy volunteers between
the ages of 18 and 80 will be enrolled. Design: The study is a double-blind crossover study
with three arms: anodal polarization, cathodal polarization, and sham treatment. Outcome
Measures: The primary outcome measures are 1) cognitive function as measured with the CalCAP
battery or 2) emotional state as measured with the Profile of Mood States. Secondary outcome
measures include tests of emotion-based decision making and social cognition.

- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
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