Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : February 25, 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
Movement Disorders

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 366 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neurobiological Studies of Functional Movement Disorders and Non-Epileptic Seizures
Actual Study Start Date : October 5, 2007

Resource links provided by the National Library of Medicine


Group/Cohort
Caregivers of PMD patients
Caregivers of patients diagnosed with PMD who are enrolled in protocol 07-N-0190. A caregiver will be defined as a subject who takes care of the patient for 10 or more hours weekly.
FMD patients
diagnosis of FMD
Healthy Volunteers
Age 18 or older, able to give informed consent
PNES
diagnosis of PNES



Primary Outcome Measures :
  1. fMRI BOLD signal change focusing on regions of interest during fear learning task [ Time Frame: throughout protocol ]
    fMRI BOLD signal change focusing on regions of interest during fear learning task

  2. fMRI BOLD signal change focusing on regions of interestduring emotional valence task [ Time Frame: throughout protocol ]
    fMRI BOLD signal change focusing on regions of interest during emotional valence task

  3. Structural grey matter brain data (VBM) [ Time Frame: throughout protocol ]
    Structural grey matter brain data (VBM)

  4. Percent BOLD signal change during interoceptive attention relative to exteroception control condition in dorsal mid-insula [ Time Frame: throughout protocol ]
    Percent BOLD signal change during interoceptive attention relative to exteroception control condition in dorsal mid-insula



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Experimental subjects will include patients with a diagnosis of PMD or PNES who have been assessed at the Human Motor Control Section (HMCS) clinic or the Epilepsy clinic at the National Institute of Neurological Disorders and Stroke, National Institutes of Health (NINDS/NIH), healthy volunteers, and caregivers. Experimental subjects will include patients with a diagnosis of PNES who have been assessed at Rhode Island Hospital.The caregiver group will include caregivers of patients diagnosed with PMD who are enrolled in protocol 07-N-0190. A caregiver will be defined as a subject who takes care of the patient for 10 or more hours weekly. The caregiver will be identified by the patient. Only one caregiver per individual patient will be enrolled in the study.Healthy volunteers will be age 18 or older.
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

<TAB>

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
Layout table for location contacts
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
Layout table for location information
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
Brown University - Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications:
Layout table for additonal information
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: February 25, 2020
Last Verified: December 4, 2019
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
Psychogenic Movement Disorder
PMD
NES
Healthy Volunteer
HV
Additional relevant MeSH terms:
Layout table for MeSH terms
Seizures
Movement Disorders
Disease
Conversion Disorder
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Somatoform Disorders
Mental Disorders