- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00273897
Electrical Polarization of the Brain in Corticobasal Syndrome
Direct Current Brain Polarization for Apraxia in Corticobasal Syndrome
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.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Validated test of ideational and ideomotor apraxia.
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Secondary Outcome Measures
Outcome Measure |
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Measures of hand dexterity and coordination.
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Collaborators and Investigators
Publications and helpful links
General Publications
- Boeve BF, Lang AE, Litvan I. Corticobasal degeneration and its relationship to progressive supranuclear palsy and frontotemporal dementia. Ann Neurol. 2003;54 Suppl 5:S15-9. doi: 10.1002/ana.10570. No abstract available.
- Boeve BF, Maraganore DM, Parisi JE, Ahlskog JE, Graff-Radford N, Caselli RJ, Dickson DW, Kokmen E, Petersen RC. Pathologic heterogeneity in clinically diagnosed corticobasal degeneration. Neurology. 1999 Sep 11;53(4):795-800. doi: 10.1212/wnl.53.4.795.
- Herwig U, Satrapi P, Schonfeldt-Lecuona C. Using the international 10-20 EEG system for positioning of transcranial magnetic stimulation. Brain Topogr. 2003 Winter;16(2):95-9. doi: 10.1023/b:brat.0000006333.93597.9d.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 060067
- 06-N-0067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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