CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00306865
NCT00306865N/ACompleted

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

National Institute of Neurological Disorders and Stroke (NINDS)·observational·Posted Mar 24, 2006·Updated Jul 2, 2017

In Brief

An observational study for Focal Dystonia. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsFocal Dystonia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 24, 2006
Enrollment StartMar 17, 2006
Study CompletionOct 14, 2010
TodayJul 2, 2026
Posted 20.3 years ago