NCT00273897

Electrical Polarization of the Brain in Corticobasal Syndrome

Completed Phase 2 Last updated 2 July 2017

What this trial tests

Phase 2 trial testing Phoresor II in Corticobasal Syndrome in 20 participants. Completed.

Timeline

30 December 2005

Primary endpoint
11 December 2007

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	20
Start date	30 December 2005
Primary completion	11 December 2007
Sites	1 location across United States

Drugs / interventions tested

• Phoresor II

Conditions studied

• Corticobasal Syndrome — all drugs for Corticobasal Syndrome →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 40 to 90, any sex, with Corticobasal Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will test whether DC electrical polarization of the brain can temporarily improve hand function in patients with corticobasal syndrome (CBS). In this degenerative disorder of the brain, nerve cells die over time, causing a progressive decline in the patient's ability to use their hands. This is always worse on one side. Other symptoms include arm or leg stiffness, tremor, gait unsteadiness, and speech difficulty. Some patients also have some decline in thinking ability, such as loss of skilled activities, poor problem solving abilities poor concentration, problems with language, and forgetfulness,. DC electrical polarization of the brain involves placing sponge electrodes on the head and passing a very weak current between them. DC polarization can temporarily improve the ability of healthy people to make word lists and may improve symptoms in some brain diseases.

Patients 40 and older with CBS who have participated in NINDS protocol 02-N-0001 ("Testing a Model of the Representational Knowledge Stored in the Human Prefrontal Cortex") may be eligible for this study. In protocol 02-N-0001, participants provide a medical history, undergo a neurological examination, PET scanning and MRI, and complete tests, such as sitting in front of a computer monitor and press a key to indicate a decision about what appears on the screen (for example, whether a statement is accurate) and answering questions from a test examiner.

For the current protocol, participants have three 2-hour testing sessions at the NIH Clinical Center, scheduled at least one day apart. In each session, sponge electrodes are placed on the head so that they affect different areas of the brain. Two areas are involved with hand movement; the third does not. The electrodes are dampened with water and attached to the sides of the patient's head. When the current is turned on, the patient may feel some tingling. The current is on for 40 minutes, but can be reduced or stopped early if the tingling becomes uncomfortable.

Before and during each session, the patients' hand function is tested by having them perform and imitate some actions, insert pegs into holes on a board, and tap their index finger as fast as they can. Part or all of the sessions are videotaped for use in evaluating the effects of DC polarization.

Publications & conference data

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