Direct Current Brain Polarization of the Frontal Lobes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00424216|
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : July 2, 2017
|First Submitted Date ICMJE||January 17, 2007|
|First Posted Date ICMJE||January 18, 2007|
|Last Update Posted Date||July 2, 2017|
|Study Start Date ICMJE||January 11, 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00424216 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Screen for other cognitive, emotional, and perceptual changes using standardized and validated neuropsychological tests.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Direct Current Brain Polarization of the Frontal Lobes|
|Official Title ICMJE||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:
Participants are called by phone on the day after each session to see how they are feeling.
|Detailed Description||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.|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Procedure: DC Polarization|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||December 23, 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Healthy volunteers over age 18. Pregnant women are eligible.
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.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00424216|
|Other Study ID Numbers ICMJE||070066
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 23, 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP