Healthy Clinical Trial
Official title:
In Vivo Mapping Of Structural and Biochemical Abnormalities In Patients With Primary Focal Dystonia
Verified date | March 10, 2015 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 189 |
Est. completion date | March 10, 2015 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
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. Review. — View Citation
Bhatia 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. — View Citation
Lee MS, Marsden CD. Movement disorders following lesions of the thalamus or subthalamic region. Mov Disord. 1994 Sep;9(5):493-507. Review. — View Citation
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