Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures

NCT00500994 | Completed Early Phase 1 FDA Device

• 2 other identifiers: 07019007-N-0190
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 2

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.

Conditions

Movement Disorders

Keywords

Conversion Disorder; Psychogenic Movement Disorders; Non-Epileptic Seizure; Functional Magnetic Resonance Imaging (fMRI); Genetic Polymorphisms

Outcome Measures

Primary Outcomes (3)

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

  fMRI BOLD signal change focusing on regions of interest during emotional valence task

  throughout

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

  The S/S genotype of the 5HTTLPR polymorphism

  throughout

• Anatomical MRI: VBM

  Structural grey matter brain data

  throughout

Study Arms (1)

fMRI study

EXPERIMENTAL

subjects receiving MRI

Device: MRI

Interventions

MRI DEVICE

The imaging study will use a block design to (i) optimize amygdala activation to emotionally valenced images, (ii) to optimize analysis of PPI and (iii) to optimize the go/no-task 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.

fMRI study

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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
• Able to give informed consent
• Age 18 or older

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Rhode Island Hospital (RIH)

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Waugh RE, Parker JA, Hallett M, Horovitz SG. Classification of Functional Movement Disorders with Resting-State Functional Magnetic Resonance Imaging. Brain Connect. 2023 Feb;13(1):4-14. doi: 10.1089/brain.2022.0001. Epub 2022 Jun 16.

  PMID: 35570651 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Movement Disorders; Conversion Disorder; Seizures

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Somatoform Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyun Joo Cho, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 13, 2007
• Study Start: October 5, 2007
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (2)