Brain Changes in Patients With Focal Hand Dystonia

Completed

Conditions studied: Focal Dystonia

In brief

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.

Key facts

Study ID: NCT00306865
Run by: National Institute of Neurological Disorders and Stroke (NINDS)
People needed: 30
Starts: 2006-03-17
Expected to finish: 2010-10-14
Last updated by the study team: 2017-07-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

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.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.