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Placebo Controlled Study of the Therapeutic Effect of the Transcranial Electrical Polarization in Patients With Focal Hand Dystonia
Sponsor study identifier
Secondary identifiers
interventional
12
1 country
1
Study Start
March 18, 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 14, 2010
Actual (reported)Study Completion
May 14, 2010
Actual (reported)This study will evaluate the effect of transcranial electrical polarization (TEP), also called direct current (DC) stimulation, on focal hand dystonia in people with writer's cramp. In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia involves just one part of the body, such as the hand, neck or face. When people with focal hand dystonia make small and repeated movements with their hands, there is extra activity in the part of the brain called the motor cortex. TEP is a method of brain stimulation that slows down the activity of the nerve cells in the motor cortex. This study may help researchers develop new ways to treat focal hand dystonia. People 18 years of age and older with focal hand dystonia may be eligible for this study. Participants have a neurological examination and are randomly assigned to one of two treatment groups: TEP or placebo stimulation. The TEP group receives stimulation to the parts of the brain used for hand movement, and the placebo group receives sham stimulation, which does not affect any area of the brain. There are three TEP/placebo sessions over a period of 7 to 10 days. The first session may last up to 2-1/2 hours; the other two sessions last 1-2 hours. For TEP, sponge electrodes are placed on the scalp and an electrical current is passed through the scalp and skull to the outer part of brain. Before and after each session, participants have a neurological examination, including an evaluation of the rate and severity of their movement problems. For this assessment, participants do a writing test while the electrical activity of their hand muscles is recorded using surface electromyography (EMG). For EMG, small metal disks (electrodes) filled with a conductive gel are taped to the skin over the muscles being tested. Patients are followed in the clinic the day after the end of TEP treatment for evaluation of their movement abilities and the effects of therapy, such as improvement of handwriting.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 14, 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 18, 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 29, 2005
Actual (reported)March 30, 2005
Actual (reported)May 14, 2010
Actual (reported)May 14, 2010
Actual (reported)The Fahn Dystonia Scale before and after real and placebo TEP course.
1 week post-TEP
Real TEP
Sham Stimulation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Agnew WF, McCreery DB. Considerations for safety in the use of extracranial stimulation for motor evoked potentials. Neurosurgery. 1987 Jan;20(1):143-7. doi: 10.1097/00006123-198701000-00030.
Antal A, Nitsche MA, Paulus W. External modulation of visual perception in humans. Neuroreport. 2001 Nov 16;12(16):3553-5. doi: 10.1097/00001756-200111160-00036.
Chen R, Wassermann EM, Canos M, Hallett M. Impaired inhibition in writer's cramp during voluntary muscle activation. Neurology. 1997 Oct;49(4):1054-9. doi: 10.1212/wnl.49.4.1054.
12 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2005
First Posted
March 30, 2005
Study Start
March 18, 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 14, 2010
Actual (reported)Study Completion
May 14, 2010
Actual (reported)Last Updated
July 2, 2017
Record last verified: 2010-05-14
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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