Protocol Details

In Vivo Mapping Of Structural and Biochemical Abnormalities In Patients With Primary Focal Dystonia

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	02-N-0132
Sponsoring Institute	National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	Currently Not Provided
Keywords	MRI; Writer's Cramp; Movement Disorder; Gray Matter; Brain Morphology
Recruitment Keyword(s)	Dystonia; Focal Hand Dystonia; Writer's Cramp; Movement Disorder; Healthy Volunteer; HV; Normal Control
Condition(s)	Dystonia; Healthy
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Neurological Disorders and Stroke

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.

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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

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Citations:

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

Bhatia KP, Marsden CD The behavioural and motor consequences of focal lesions of the basal ganglia inman Brain 1994 Aug;117 ( Pt 4):859-76

Lee MS, Marsden CD Movement disorders following lesions of the thalamus or subthalamic region Mov Disord 1994 Sep;9(5):493-507

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Contacts:

Principal Investigator	Referral Contact	For more information:
Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health BG 10 RM 7D37 MSC 1428 10 CENTER DR BETHESDA MD 20892-1428 (301) 496-9526 hallettm@ninds.nih.gov	Elaine P. Considine, R.N. National Institute of Neurological Disorders and Stroke (NINDS) National Institutes of Health Building 10 Room 7D36 10 Center Drive Bethesda, Maryland 20892 (301) 435-8518 considinee@ninds.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00031369

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