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 range18 Years – 99 Years

SexALL

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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…

What they're measuring

fMRI study: blood oxygenation level dependent (BOLD) signal in the regions of interest during a gender identification task

Timeframe: throughout

Genetics: S/S genotype of the serotonin transporter promoter region polymorphism.

Timeframe: throughout

Anatomical MRI: VBM

Timeframe: throughout

Trial details

NCT IDNCT00500994

SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2022-12-13

View on ClinicalTrials.gov More Movement Disorders trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.