Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031369
Status:
TERMINATED
Last Update Posted:
2017-10-06
First Post:
2002-03-02
Brief Title:
Brain Anatomy in Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
In Vivo Mapping Of Structural and Biochemical Abnormalities In Patients With Primary Focal Dystonia
Status:
TERMINATED
Status Verified Date:
2015-03-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 parts 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 concentrationvolume of graywhite 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 pathogenesisetiology 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
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 parts 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 concentrationvolume of graywhite 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 pathogenesisetiology 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-N-0132 | None | None | None |