Neurobiology of Psychogenic Movement Disorder and Non-Epileptic Seizures
|First Received Date ICMJE||July 12, 2007|
|Last Updated Date||January 20, 2017|
|Start Date ICMJE||July 11, 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00500994 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Neurobiology of Psychogenic Movement Disorder and Non-Epileptic Seizures|
|Official Title ICMJE||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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||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.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||320|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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 ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00500994|
|Other Study ID Numbers ICMJE||070190, 07-N-0190|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Neurological Disorders and Stroke (NINDS)|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 6, 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP