Brain Anatomy in Dystonia
In Vivo Mapping Of Structural and Biochemical Abnormalities In Patients With Primary Focal Dystonia
2 other identifiers
observational
189
1 country
1
Brief Summary
This study will use high-resolution magnetic resonance imaging (MRI) to look for subtle differences in brain anatomy between patients with focal hand dystonia (also called writer s cramp) and healthy normal volunteers. Patients with hand dystonia have prolonged muscle contractions that cause sustained twisting movements and abnormal postures. These abnormal movements often occur with activities such as writing, typing, playing certain musical instruments such as guitar or piano, or playing golf or darts. Patients with focal hand dystonia and healthy volunteers will be enrolled in this study. Patients will be recruited from NINDS s database of patients with focal hand dystonia. Volunteers will be selected to match the patients in age, sex and handedness. This study involves two visits to the NIH Clinical Center. The first visit is a screening visit, in which patients and volunteers will have a medical history, physical examination, neurological examination, and assessment of handedness. Women of childbearing age will be screened with a pregnancy test. Pregnant women are exclude from this study. Those who join the study will return for a second visit for magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images of the brain. For the procedure, the participant lies still on a stretcher that is moved into the scanner (a narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. The scan will last about 45 to 60 minutes, at most. Some volunteers may be asked to return for a third visit to obtain a second MRI on a different scanner.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2002
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
February 27, 2002
CompletedFirst Submitted
Initial submission to the registry
March 2, 2002
CompletedFirst Posted
Study publicly available on registry
March 4, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2015
CompletedOctober 6, 2017
March 10, 2015
March 2, 2002
October 5, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- HEALTHY VOLUNTEERS: Healthy volunteers who consented to participate in the study and matched for age, sex, handedness with the group of patients with primary focal hand dystonia.
- PATIENTS: Patient with primary focal dystonia from our dystonia patient database who consented to participate in the study. This criterion will be established by the preliminary screening in the Human Motor Control Outpatient Clinic.
You may not qualify if:
- The following subjects will be excluded:
- Healthy volunteers with cognitive complaints, abnormal neurological exam or history of past neurological disease.
- Dystonia patients with the presence of a second neurological disease or condition; abnormal neurological findings on exam that are not related to primary focal dystonia.
- Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, migraine, past and present history of alcohol abuse, medical conditions that may alter cerebral structure.
- Subjects with abnormal MRI findings at visual inspection (prominent normal variants such as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or AVMs).
- Subjects with any metallic objects within them just prior to MR imaging (cardiac or neural pacemaker, aneurysm clips \[metal clips on the wall of a large artery\], metallic prostheses \[including heart valves and cochlear implants\] or shrapnel fragments. Welders and metal workers are also at risk for injury and may not take part in the study because of possible small metal fragments in the eye of which they may be unaware.
- Subjects not capable of giving an informed consent.
- Women who are pregnant
- Children
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: 9679773BACKGROUNDBhatia KP, Marsden CD. The behavioural and motor consequences of focal lesions of the basal ganglia in man. Brain. 1994 Aug;117 ( Pt 4):859-76. doi: 10.1093/brain/117.4.859.
PMID: 7922471BACKGROUNDLee MS, Marsden CD. Movement disorders following lesions of the thalamus or subthalamic region. Mov Disord. 1994 Sep;9(5):493-507. doi: 10.1002/mds.870090502.
PMID: 7990845BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Hallett, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2002
First Posted
March 4, 2002
Study Start
February 27, 2002
Study Completion
March 10, 2015
Last Updated
October 6, 2017
Record last verified: 2015-03-10