Brain Changes in Patients With Focal Hand Dystonia (NCT00306865) | Clinical Trial Compass
CompletedNot Applicable
Brain Changes in Patients With Focal Hand Dystonia
United States30 participantsStarted 2006-03-17
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 los…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00306865
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)