Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures (NCT00500994) | Clinical Trial Compass
CompletedEarly Phase 1
Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures
United States254 participantsStarted 2007-10-05
Plain-language summary
This study is part of a series of studies that will explore how the mind and the brain work to cause episodes of uncontrollable shaking in people who have no known underlying brain or medical disorder. The study is conducted at NIH and at the Brown University Rhode Island Hospital.
Healthy volunteers and people with functional movement disorders (FMD) or non-epileptic seizures (NES) who are 18 years of age or older may be eligible for this study.
Patients with NES have 3 teaspoons of blood drawn. The blood is tested for two genes that are normally found in healthy individuals to see if they are found more frequently in patients with uncontrolled shaking.
Patients with FMD have blood drawn for testing and also undergo functional magnetic resonance imaging (fMRI) to look at how the brain functions while the subject performs a specific task. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the scan, the subject lies on a table that can slide in and out of the scanner, a metal cylinder. The scan lasts about 60 to 90 minutes, during which the subject may be asked to lie still for up to 10 minutes at a time and to perform tasks, such as identifying the gender of faces shown on a screen.
Healthy volunteers may have blood drawn for genetic testing or fMRI or both.
Who can participate
Age range
18 Years – 99 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:
General Inclusion Criteria for FMD patients:
* Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria. The diagnosis must be made by a neurologist
* Able to give informed consent
* Age 18 or older
General Inclusion Criteria for Caregivers:
* Age 18 or older
* Able to give informed consent
* Takes care of a patient with FMD patient enrolled in protocol 07-N-0190 for 10 or more weekly hours.
General Inclusion Criteria for PNES patients:
* Diagnosis of PNES based on recording of patient s typical episode during 24 h video-EEG without concomitant EEG changes. The diagnosis must be made by a neurologist.
* Able to give informed consent
* Age 18 or older
General Inclusion Criteria for Healthy Volunteers:
* Able to give informed consent
* Age 18 or older
EXCLUSION CRITERIA:
General exclusion criteria for FMD patients:
* Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy
* Inflammatory disorders or autoimmune disorders active within the last 6 months
* Patients with psychotic disorders or manic depression or active substance abuse within the last 6 months
* Current suicidal ideation
* Disease severity requiring inpatient treatment
Additional exclusion criteria for FMD patients for MRI:
* Patients with movement symptoms at rest that may substantially inhibit resolution, comfort, or safety of MRI
* Previous history of or MRI findings consistent with br…
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.
What they're measuring
1
fMRI study: blood oxygenation level dependent (BOLD) signal in the regions of interest during a gender identification task
Timeframe: throughout
2
Genetics: S/S genotype of the serotonin transporter promoter region polymorphism.
Timeframe: throughout
3
Anatomical MRI: VBM
Timeframe: throughout
Trial details
NCT IDNCT00500994
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)