Brain Anatomy in Dystonia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00031369
First received: March 2, 2002
Last updated: March 22, 2014
Last verified: March 2014

March 2, 2002
March 22, 2014
February 2002
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00031369 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Brain Anatomy in Dystonia
In Vivo Mapping Of Structural and Biochemical Abnormalities In Patients With Primary Focal Dystonia

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.

Objective

The term, dystonia, is used to describe a syndrome characterized by prolonged muscle contractions causing sustained twisting movements and abnormal postures of the affected body part(s). Although no structural brain abnormalities have been definitively demonstrated in the visual inspection of MRI scans from patients with primary focal dystonia, there are several lines of evidence for subtle structural brain abnormalities at both the subcortical and cortical levels. We hypothesize that those abnormalities might be detected by using appropriate acquisition and analysis methods.

Study population

This research will be conducted using patients with primary focal dystonia and normal volunteers.

Design

By using high-resolution 3D structural magnetic resonance imaging (MRI) of the brain and voxel-based morphometry (VBM), and diffusion tensor imaging (DTI) at 3 Tesla and high resolution anatomical images at 7 Tesla, we will detect structural changes in patients with primary focal dystonia in comparison with control subjects. VBM and DTI are methods implemented in the statistical parametric mapping software (SPM2). Magnetic resonance spectroscopy (MRS) will use special software to calculate gamma-aminobutyric acid (GABA) levels in a region of interest.

Outcome measures

VBM and DTI analysis in SPM2 will enable us to make a voxel-wise comparison of local concentration/volume of gray/white matter among these groups of subjects. This study can lead to an improved knowledge of the pathophysiology of primary hand dystonia can help to elucidate dystonia s pathogenesis/etiology and may lead to specific preventative or therapeutic approaches. The MRS study will enable us to study GABA levels in the sensory motor cortices, prefrontal cortex and basal ganglia in primary dystonia patients and normal subjects.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • Dystonia
  • Healthy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
275
Not Provided
Not Provided
  • 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

Both
18 Years and older
Yes
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov
United States
 
NCT00031369
020132, 02-N-0132
Not Provided
Not Provided
National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP