Brain Activity in People With Functional Movement Disorders (NCT00448084) | Clinical Trial Compass
CompletedNot Applicable
Brain Activity in People With Functional Movement Disorders
United States65 participantsStarted 2007-03-08
Plain-language summary
This study will use functional MRI (fMRI, a technique that shows what areas of the brain are active when performing different mental tasks), to examine how the brain in people with functional movement disorders (FMD) may differ from that in people without FMDs. People with FMD have movement symptoms they feel they cannot control and that are not due to a known medical disorder. Previous studies looking at the brain activity of FMD patients have found areas in the frontal lobe of the brain that appeared overactive. These overactive areas may make it difficult to perform complex mental tasks. Studying the brain during performance of these tasks may enhance knowledge about FMD.
Patients 18 years of age or older with an FMD and healthy normal volunteers may be eligible for this study. Participants have two visits to the NIH Clinical Center for the following procedures:
First visit (screening):
* Medical history and neurological examination.
* Urine drug screen for illicit drugs.
* Psychological testing, including an interview and questionnaires.
Second visit:
* Brain MRI (if one has not been done at NIH within the past 12 months): MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud noises that occur during the scanning process. The procedure lasts about 2 hours, during which time the patient is asked to lie still for up to 30 minutes at a time.
* Brain fMRI: While in the MRI scanner, subjects read questions and answer them yes or no by pushing buttons. They are asked to answer questions about their health, their movement symptoms and unrelated topics (like personal preferences and current events). The questions vary in difficulty. Sometimes subjects are instructed to answer correctly; other times they are asked to answer incorrectly. A strap is placed around the subject's chest and two wires are taped to the fingers to monitor heart rate, breathing rate and sweat response during the scan. The scan takes about 2 hours.
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:
PATIENTS:
* Age 18 to 65
* Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the fMRI scanning
* Diagnosis of a functional movement disorder confirmed by a study investigator
HEALTHY VOLUNTEERS:
\- Age 18 to 65
EXCLUSION CRITERIA:
* Subjects with any abnormal findings on neurological exam consistent with an organic disorder
* Subjects with a positive urine pregnancy test
* Subjects with a positive urine drug screen
* Subjects who are pregnant
* Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
* Subjects with metallic dental fillings which are likely to enhance MRI artifacts
* Subjects with any history of dementia, brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies
* Subjects with moderate to severe brain atrophy on imaging studies, as assessed by a study investigator
* Subjects with any history of a severe medical condition, such as cardiovascular disease, which would prevent them from lying flat for up to 120 minutes
* Subjects without the capacity to give informed consent
* Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 120 minutes
* Subjects using beta-blocker medications or other chronotropes which may inhibit the cardiac responsivity
* Patient whose movement frequency and severity prevents them from undergoing MRI safely and e…
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 IDNCT00448084
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)