NCT00944931

High-Density Direct Current Brain Polarization

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing DC Brain Polarization in Healthy Volunteer in 30 participants. Completed in 5 April 2011.

Timeline

20 July 2009

Primary endpoint
5 April 2011

5 April 2011

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	20 July 2009
Primary completion	5 April 2011
Estimated completion	5 April 2011
Sites	1 location across United States

Drugs / interventions tested

• DC Brain Polarization

Conditions studied

• Healthy Volunteer — all drugs for Healthy Volunteer →
• HV — all drugs for HV →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

18 and older, any sex, with Healthy Volunteer or HV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.