Sponsor study identifier
Secondary identifiers
observational
51
1 country
1
Study Start
March 30, 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
March 13, 2012
Date type not reportedThis date has not been verified as actual or estimated.
This study will examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study which areas of the brain are primarily affected in FHD and better understand how brain changes produce dystonia symptoms. Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations. Women who can become pregnant have a urine pregnancy test. All participants undergo fMRI. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient is asked to lie still for 10-15 minutes at a time. During the procedure, subjects are asked to perform some tasks, including writing, tapping with their hand, and drawing in a zigzag motion. Each task is performed using the right hand, left hand and right foot.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 13, 2012
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 30, 2006
Date type not reportedThis date has not been verified as actual or estimated.
March 31, 2006
Actual (reported)April 3, 2006
Actual (reported)March 13, 2012
Date type not reportedThis date has not been verified as actual or estimated.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.
Butterworth S, Francis S, Kelly E, McGlone F, Bowtell R, Sawle GV. Abnormal cortical sensory activation in dystonia: an fMRI study. Mov Disord. 2003 Jun;18(6):673-82. doi: 10.1002/mds.10416.
Blood AJ, Flaherty AW, Choi JK, Hochberg FH, Greve DN, Bonmassar G, Rosen BR, Jenkins BG. Basal ganglia activity remains elevated after movement in focal hand dystonia. Ann Neurol. 2004 May;55(5):744-8. doi: 10.1002/ana.20108.
Kenneth H Fischbeck, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
51 participants (actual enrollment reported by the registry).
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
March 30, 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
Contact the study team to confirm eligibility.
March 13, 2012
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
July 2, 2017
Record last verified: 2012-03-13
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Source: ClinicalTrials.gov.
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