Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306865
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-03-23
Brief Title:
Brain Changes in Patients With Focal Hand Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Density and Pattern of Distribution of GABA A Receptors in the Brain of Patients With Focal Hand Dystonia Studied With PET Using 11C Flumazenil
Status:
COMPLETED
Status Verified Date:
2010-10-14
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 examine how chemical changes in the brain produce symptoms of hand dystonia Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures In focal dystonia just one part of the body such as the hand neck or face is involved The study will use positron emission tomography PET to find our which areas of the brain in patients with focal hand dystonia differ from healthy volunteers without focal hand dystonia
Healthy volunteers and patients with focal hand dystonia between 18 and 65 years of age may be eligible for this study Candidates are screened with a medical history and physical and neurological examinations
Participants undergo the following procedures
PET scanning The PET scanner is shaped like a doughnut The subject lies on a bed that can slide in and out of the scanner A custom-molded plastic mask is placed on the face and head to support the head and prevent it from moving during scanning Two radioactive substances - five doses one per scan of 15 O water and one dose of 11C flumazil are injected into the body through a vein The dose of injected radioactive substance is very small and they are not harmful to the body The 15 O water doses are injected during the first hour and scans are taken every 10 minutes The 11C flumazil is injected during the second hour The radioactive substances are detected by the PET scanner and provide information on the functioning of the brain chemistry
MRI scanning MRI uses a magnetic field and radio waves to produce images of body tissues and organs The patient lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process Scanning time for this study will be less than one hour Subjects may be asked to lie still for up to 10 minutes at a time
Healthy volunteers and patients with focal hand dystonia between 18 and 65 years of age may be eligible for this study Candidates are screened with a medical history and physical and neurological examinations
Participants undergo the following procedures
PET scanning The PET scanner is shaped like a doughnut The subject lies on a bed that can slide in and out of the scanner A custom-molded plastic mask is placed on the face and head to support the head and prevent it from moving during scanning Two radioactive substances - five doses one per scan of 15 O water and one dose of 11C flumazil are injected into the body through a vein The dose of injected radioactive substance is very small and they are not harmful to the body The 15 O water doses are injected during the first hour and scans are taken every 10 minutes The 11C flumazil is injected during the second hour The radioactive substances are detected by the PET scanner and provide information on the functioning of the brain chemistry
MRI scanning MRI uses a magnetic field and radio waves to produce images of body tissues and organs The patient lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process Scanning time for this study will be less than one hour Subjects may be asked to lie still for up to 10 minutes at a time
Detailed Description:
Objective
The purpose of this study is to determine if in focal hand dystonia there is disinhibition involving key structures of the motor control system basal ganglia thalamus cerebellum and motor cortex caused by dysfunction of the GABA-ergic neurons The major inhibitory neurotransmitter in the central nervous system is gamma-amino butyric acid GABA which acts mainly through GABA A receptors the majority of which possess the benzodiazepine binding site Pathological processes involving GABA-ergic neurons will cause alterations in the density of GABA receptors which can be visualized and measured with positron emission tomography PET using as a radioactive ligand 11C Flumazenil
Study Population
This research will be conducted using 20 patients with primary focal hand dystonia and 20 healthy volunteers that are matched by age and gender
Design
By using positron emission tomography PET using radioactive ligand 11C Flumazenil we will detect alterations in the density of GABA receptors in patients with primary focal hand dystonia in comparison with control subjects
Outcome Measures
We will be able to determine the density of GABA A receptors of the various Regions of Interest as measured by PET analysis among these groups of subjects This study should provide new information concerning localization and degree of dysfunction of GABA-ergic neurons in movement related structures in dystonia which might open new possibilities for pharmacological treatment of this disorder
The purpose of this study is to determine if in focal hand dystonia there is disinhibition involving key structures of the motor control system basal ganglia thalamus cerebellum and motor cortex caused by dysfunction of the GABA-ergic neurons The major inhibitory neurotransmitter in the central nervous system is gamma-amino butyric acid GABA which acts mainly through GABA A receptors the majority of which possess the benzodiazepine binding site Pathological processes involving GABA-ergic neurons will cause alterations in the density of GABA receptors which can be visualized and measured with positron emission tomography PET using as a radioactive ligand 11C Flumazenil
Study Population
This research will be conducted using 20 patients with primary focal hand dystonia and 20 healthy volunteers that are matched by age and gender
Design
By using positron emission tomography PET using radioactive ligand 11C Flumazenil we will detect alterations in the density of GABA receptors in patients with primary focal hand dystonia in comparison with control subjects
Outcome Measures
We will be able to determine the density of GABA A receptors of the various Regions of Interest as measured by PET analysis among these groups of subjects This study should provide new information concerning localization and degree of dysfunction of GABA-ergic neurons in movement related structures in dystonia which might open new possibilities for pharmacological treatment of this disorder
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 |
|---|---|---|---|
| 06-N-0031 | None | None | None |