fMRI Studies of Task Specificity in Focal Hand Dystonia
2 other identifiers
observational
51
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2006
CompletedFirst Submitted
Initial submission to the registry
March 31, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2012
CompletedJuly 2, 2017
March 13, 2012
March 31, 2006
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Focal Dystonia Subjects must be:
- Right hand dominant
- Between 18 and 65 years old
- Diagnosed with mild, simple focal hand dystonia. For this study mild, simple focal hand dystonia suggests that the patient does not present symptoms when performing tasks other than writing. Additionally, the patient should be able to write for 20 seconds consecutively
- Willing to abstain from alcohol 48 hours prior to the study
- Volunteers must be:
- Healthy right-handed dominant individuals
- Between 18 and 65 years old
- Willing to abstain from alcohol 48 hours prior to the study
You may not qualify if:
- Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI
- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
- Subjects who are pregnant.
- Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes
- Subjects with any visual, motor, or hearing difficulties
- Subjects with severe focal hand dystonia i.e., subjects who experience dystonic spasms in tasks other than/in addition to writing
- Subjects with mirror dystonia
- Subjects without the capacity to give consent
- Subjects with any history of a severe medical condition, such as cardiovascular disease, which will prevent them from lying flat for up to 60 minutes.
- Subjects with any history of brain tumor, stroke, head trauma or vascular malformation as obtained by history or from imaging studies.
- Subjects who have had recent (within 3 months) Botulinum Toxin (Botox) injections.
- Subjects who are on anti-parkinsonian drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
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.
PMID: 9679773BACKGROUNDButterworth 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.
PMID: 12784271BACKGROUNDBlood 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.
PMID: 15122718BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth H Fischbeck, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 31, 2006
First Posted
April 3, 2006
Study Start
March 30, 2006
Study Completion
March 13, 2012
Last Updated
July 2, 2017
Record last verified: 2012-03-13