fMRI Studies of Task Specificity in Focal Hand Dystonia (NCT00310414) | Clinical Trial Compass
CompletedNot Applicable
fMRI Studies of Task Specificity in Focal Hand Dystonia
United States51 participantsStarted 2006-03-30
Plain-language summary
This study will examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study which areas of the brain are primarily affected in FHD and better understand how brain changes produce dystonia symptoms.
Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations. Women who can become pregnant have a urine pregnancy test.
All participants undergo fMRI. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient is asked to lie still for 10-15 minutes at a time. During the procedure, subjects are asked to perform some tasks, including writing, tapping with their hand, and drawing in a zigzag motion. Each task is performed using the right hand, left hand and right foot.
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:
Focal Dystonia Subjects must be:
* Right hand dominant
* Between 18 and 65 years old
* Diagnosed with mild, simple focal hand dystonia. For this study mild, simple focal hand dystonia suggests that the patient does not present symptoms when performing tasks other than writing. Additionally, the patient should be able to write for 20 seconds consecutively
* Willing to abstain from alcohol 48 hours prior to the study
Volunteers must be:
* Healthy right-handed dominant individuals
* Between 18 and 65 years old
* Willing to abstain from alcohol 48 hours prior to the study
EXCLUSION CRITERIA:
* Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI
* Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
* Subjects who are pregnant.
* Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes
* Subjects with any visual, motor, or hearing difficulties
* Subjects with severe focal hand dystonia i.e., subjects who experience dystonic spasms in tasks other than/in addition to writing
* Subjects with mirror dystonia
* Subjects without the capacity to give consent
* Subjects with any history of a severe medical condition, suc…
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 IDNCT00310414
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)