|First Submitted Date||July 12, 2007|
|First Posted Date||July 13, 2007|
|Last Update Posted Date||August 23, 2017|
|Start Date||July 11, 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00500994 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Neurobiology of Psychogenic Movement Disorder and Non-Epileptic Seizures|
|Official Title||Neurobiological Studies of Psychogenic Movement Disorders and Non-Epileptic Seizures|
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 psychogenic movement disorders (PMD) 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 PMD 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.
The study investigates the neurobiological correlates of conversion disorder (CD). The primary objectives are to investigate in CD patients:
Exploratory objectives are to investigate in CD patients:
We intend to study adult patients with diagnoses of psychogenic movement disorders (PMD) seen by the Human Motor Control Section clinic (HMCS), patients with diagnoses of psychogenic non-epileptic seizures (PNES) seen by the Epilepsy clinic and healthy volunteers. The PNES patient group will include patients seen at Rhode Island Hospital. Additionally, we would like to study caregivers of patient's with PMD who are enrolled un protocol 07-N-0190.
An assessment for psychiatric diagnoses and measurement scales will be administered to the PMD and PNES patients, healthy volunteer controls and caregivers.
|Study Design||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
General Inclusion Criteria for PMD patients:
General Inclusion Criteria for Caregivers:
General Inclusion Criteria for PNES patients:
General Inclusion Criteria for Healthy Volunteers:
General exclusion criteria for PMD patients:
Additional exclusion criteria for PMD patients for MRI:
General exclusion criteria for PNES patients:
General exclusion criteria for healthy volunteers:
Additional exclusion criteria for healthy volunteers for MRI:
General Exclusion Criteria for Caregivers:
|Ages||18 Years to 90 Years (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||070190
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 14, 2017|