Electrical Polarization of the Brain in Corticobasal Syndrome
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ClinicalTrials.gov Identifier: NCT00273897 |
Recruitment Status :
Completed
First Posted : January 9, 2006
Last Update Posted : July 2, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Corticobasal Syndrome | Device: Phoresor II | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 20 participants |
Primary Purpose: | Treatment |
Official Title: | Direct Current Brain Polarization for Apraxia in Corticobasal Syndrome |
Study Start Date : | December 30, 2005 |
Actual Primary Completion Date : | December 11, 2007 |

- Validated test of ideational and ideomotor apraxia.
- Measures of hand dexterity and coordination.

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Ages Eligible for Study: | 40 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
- Clinically diagnosed CBS, consisting of progressive asymmetric rigidity and apraxia and additional findings suggesting cortical (e.g., one or more of the following: alien limb phenomenon, apraxia of speech, cortical sensory loss, constructional dyspraxia, hemisensory neglect, myoclonus, mirror movements) and basal ganglionic (e.g., one or more of the following: bradykinesia, dystonia, tremor, postural instability) dysfunction.
- Patients fitting these criteria will be identified among those referred to protocol 02-N-0001. All must have been evaluated under this protocol.
- Enough residual hand function on one side to perform the tests.
- Age greater than or equal to 40: This limit is justified because the diagnosis of CBS would be very uncertain in anyone under this age.
EXCLUSION CRITERIA:
- Presence of metal in the cranial cavity or calvarium.
- Uncontrolled medical problems, such as uncontrolled diabetes mellitus, hypertension, airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for participation.
- Broken skin in the area of the electrodes.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273897
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | Eric M. Wassermann, M.D./National Institute of Neurological Disorders and Stroke, National Institutes of Health |
ClinicalTrials.gov Identifier: | NCT00273897 |
Other Study ID Numbers: |
060067 06-N-0067 |
First Posted: | January 9, 2006 Key Record Dates |
Last Update Posted: | July 2, 2017 |
Last Verified: | December 16, 2008 |
Dementia Treatment Hand Function Clinical Trials Dementia |
Cortical Syndrome CBS Apraxia |
Syndrome Disease Pathologic Processes |