Status:
COMPLETED
Brain Changes in Patients With Focal Hand Dystonia
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Focal Dystonia
Eligibility:
All Genders
18-65 years
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 abnor...
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 moto...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A. Patients will have clinically documented focal hand dystonia. This criterion will be established by the preliminary screening in the NINDS Human Motor Control Section Outpatient Clinic.
- B. Patients (male or female) will range in age from 18 through 65 years of age. Female patients of childbearing potential will have a pregnancy test, which must be negative and an interview prior to the study to ensure that pregnant patients do not participate in the study. Subjects will be asked to abstain from alcohol for one week prior to the study.
- C. Twenty healthy volunteers will be included; volunteers will be screened in the NINDS Human Motor Control Section Outpatient Clinic, and will have neurological and physical examinations. Healthy volunteers with chronic illnesses, taking any medication that affects the CNS will be excluded. Subjects will be asked to abstain from alcohol for one week prior to the study. Female volunteers of childbearing potential will have a pregnancy test, which must be negative and an interview prior to the study to ensure that pregnant subjects do not participate in the study.
- EXCLUSION CRITERIA:
- The following subjects will be excluded:
- A. Subjects younger than 18 and older than 65 years old.
- B. Subjects with MRI findings consistent with brain tumors, strokes, trauma or AVMs.
- C. Patients with progressive neurological disorders other than dystonia.
- D. 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.
- E. Subjects with cancer, except for skin cancer.
- F. Subjects incapable of giving an informed consent
- G. Subjects who are pregnant or breastfeeding
- H. Patients who are currently on benzodiazepines, which binds GABA-A receptors and will compete directly with flumazenil for binding; baclofen which binds GABA-B receptors; flunitrazepam, a benzodiazepine receptor agonist; or triazolam, a partial allosteric modulator of GABA A receptors. Patients need to be off of these medications for four weeks prior to entering the study.
- I. Patients who have had recent (within 3 months) BoTox injections. Botulinum Toxin A (BoTox) injections are commonly used to relieve pain and muscle spasms of dystonic patients.
- Participation of Children
- Patients or healthy subjects younger than 18 years of age will be excluded from the study due to the following reasons:
- (i) Absorbed radiation dose per mCi is relatively higher, and pharmacodynamic effects are greater in children compared to adults. (ii) No direct benefit for individual patients is anticipated from this study. The study is of "greater than minimal risk", and thus does not meet the criterion of 45 CFR 46 Subpart D (the "prospect of direct benefit") governing participation of children in research.
Exclusion
Key Trial Info
Start Date :
March 17 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 14 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00306865
Start Date
March 17 2006
End Date
October 14 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892