Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures
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|ClinicalTrials.gov Identifier: NCT00500994|
Recruitment Status : Recruiting
First Posted : July 13, 2007
Last Update Posted : April 20, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Movement Disorders||Device: MRI||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||366 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Neurobiological Studies of Functional Movement Disorders and Non-Epileptic Seizures|
|Actual Study Start Date :||October 5, 2007|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: fMRI study
subjects receiving MRI
The imaging study will use a block design to (i) optimize amygdala activation to emotionally balanced images, (ii) to optimize analysis of PPI and (iii) to optimize the go/notask design. G. T2- sensitive functional images will be obtained on a MRI system with a 1.5 Tesla superconducting magnet and a standard head coil. An echo planar image sequence (TR=2500msec, TE=33 msec, 90 flip angle) with 30 contiguous 2mm thick coronal oblique slices with 1 mm interslice gap centered over the amygdala, tilted 30 to the anterior, to improve susceptibility artifact. Three dimensional anatomical images will be taken for the co-registration of the functional images.
- fMRI study: blood oxygenation level dependent (BOLD) signal in the regions of interest during a gender identification task [ Time Frame: throughout ]fMRI BOLD signal change focusing on regions of interest during emotional valence task
- Genetics: S/S genotype of the serotonin transporter promoter region polymorphism. [ Time Frame: throughout ]The S/S genotype of the 5HTTLPR polymorphism
- Anatomical MRI: VBM [ Time Frame: throughout ]Structural grey matter brain data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500994
|Contact: Elaine P Considine, R.N.||(301) firstname.lastname@example.org|
|Contact: Mark Hallett, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|United States, Rhode Island|
|Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Anita Curran 401-444-3942 email@example.com|
|Principal Investigator:||Mark Hallett, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|