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Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00500994
Recruitment Status : Recruiting
First Posted : July 13, 2007
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief 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.


Condition or disease Intervention/treatment Phase
Movement Disorders Device: MRI Early Phase 1

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fMRI study
subjects receiving MRI
Device: 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.




Primary Outcome Measures :
  1. 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

  2. Genetics: S/S genotype of the serotonin transporter promoter region polymorphism. [ Time Frame: throughout ]
    The S/S genotype of the 5HTTLPR polymorphism

  3. Anatomical MRI: VBM [ Time Frame: throughout ]
    Structural grey matter brain data



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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 brain tumors, strokes, trauma or arterial venous malformations
  • History of traumatic brain injury with loss of consciousness or amnesia lasting greater than a few seconds
  • Contraindication to MRI
  • Pregnancy
  • Significant medical illness
  • Patients with current post-traumatic stress disorder
  • Patients on tricyclic antidepressants or antiepileptic medications 2 weeks prior to testing

General exclusion criteria for PNES 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 active substance abuse within the last 6 months
  • Current suicidal ideation
  • Disease severity requiring inpatient treatment

General exclusion criteria for healthy volunteers:

  • Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy
  • History of DSM IV-defined schizophrenia, schizoaffective disorder, bipolar disorder or major depression with psychosis
  • History of psychotic disorders or manic depression or active substance abuse within the last 6 months
  • Subjects with post-traumatic stress disorder
  • Subjects on antidepressants or antiepileptic medications
  • Inflammatory disorders or autoimmune disorders active within the last 6 months

Additional exclusion criteria for healthy volunteers for MRI:

  • Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations
  • Contraindication to MRI
  • Pregnancy
  • Significant medical illness

General Exclusion Criteria for Caregivers:

  • History of DSM-IV defined Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major depression with psychotic features (by interview).
  • Active substance abuse within the past 6 months (by interview).

Information from the National Library of Medicine

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


Contacts
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Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov

Locations
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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    prpl@cc.nih.gov   
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Anita Curran    401-444-3942    acurran@lifespan.org   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00500994    
Other Study ID Numbers: 070190
07-N-0190
First Posted: July 13, 2007    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 15, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Conversion Disorder
Psychogenic Movement Disorders
Non-Epileptic Seizure
Functional Magnetic Resonance Imaging (fMRI)
Genetic Polymorphisms
Additional relevant MeSH terms:
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Seizures
Movement Disorders
Disease
Conversion Disorder
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Somatoform Disorders
Mental Disorders