NCT00448084

Brief Summary

This study will use functional MRI (fMRI, a technique that shows what areas of the brain are active when performing different mental tasks), to examine how the brain in people with functional movement disorders (FMD) may differ from that in people without FMDs. People with FMD have movement symptoms they feel they cannot control and that are not due to a known medical disorder. Previous studies looking at the brain activity of FMD patients have found areas in the frontal lobe of the brain that appeared overactive. These overactive areas may make it difficult to perform complex mental tasks. Studying the brain during performance of these tasks may enhance knowledge about FMD. Patients 18 years of age or older with an FMD and healthy normal volunteers may be eligible for this study. Participants have two visits to the NIH Clinical Center for the following procedures: First visit (screening):

  • Medical history and neurological examination.
  • Urine drug screen for illicit drugs.
  • Psychological testing, including an interview and questionnaires. Second visit:
  • Brain MRI (if one has not been done at NIH within the past 12 months): MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud noises that occur during the scanning process. The procedure lasts about 2 hours, during which time the patient is asked to lie still for up to 30 minutes at a time.
  • Brain fMRI: While in the MRI scanner, subjects read questions and answer them yes or no by pushing buttons. They are asked to answer questions about their health, their movement symptoms and unrelated topics (like personal preferences and current events). The questions vary in difficulty. Sometimes subjects are instructed to answer correctly; other times they are asked to answer incorrectly. A strap is placed around the subject's chest and two wires are taped to the fingers to monitor heart rate, breathing rate and sweat response during the scan. The scan takes about 2 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2007

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2008

Completed
Last Updated

July 2, 2017

Status Verified

August 5, 2008

First QC Date

March 14, 2007

Last Update Submit

June 30, 2017

Conditions

Keywords

Psychogenic Movement DisordersVolitionfMRIFunctional MRIFunctional Movement DisorderHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PATIENTS:
  • Age 18 to 65
  • Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the fMRI scanning
  • Diagnosis of a functional movement disorder confirmed by a study investigator
  • HEALTHY VOLUNTEERS:
  • \- Age 18 to 65

You may not qualify if:

  • Subjects with any abnormal findings on neurological exam consistent with an organic disorder
  • Subjects with a positive urine pregnancy test
  • Subjects with a positive urine drug screen
  • Subjects who are pregnant
  • Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
  • Subjects with metallic dental fillings which are likely to enhance MRI artifacts
  • Subjects with any history of dementia, brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies
  • Subjects with moderate to severe brain atrophy on imaging studies, as assessed by a study investigator
  • Subjects with any history of a severe medical condition, such as cardiovascular disease, which would prevent them from lying flat for up to 120 minutes
  • Subjects without the capacity to give informed consent
  • Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 120 minutes
  • Subjects using beta-blocker medications or other chronotropes which may inhibit the cardiac responsivity
  • Patient whose movement frequency and severity prevents them from undergoing MRI safely and effectively for the purposes of data collection
  • Patient with a pending medical-legal case
  • Subjects with suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Barry RL, Menon RS. Modeling and suppression of respiration-related physiological noise in echo-planar functional magnetic resonance imaging using global and one-dimensional navigator echo correction. Magn Reson Med. 2005 Aug;54(2):411-8. doi: 10.1002/mrm.20591.

    PMID: 16032665BACKGROUND
  • Bash IY, Alpert M. The determination of malingering. Ann N Y Acad Sci. 1980;347:86-99. doi: 10.1111/j.1749-6632.1980.tb21257.x. No abstract available.

    PMID: 6930923BACKGROUND
  • Cragar DE, Berry DT, Fakhoury TA, Cibula JE, Schmitt FA. Performance of patients with epilepsy or psychogenic non-epileptic seizures on four measures of effort. Clin Neuropsychol. 2006 Sep;20(3):552-66. doi: 10.1080/13854040590947380.

    PMID: 16895866BACKGROUND

MeSH Terms

Conditions

Conversion DisorderSelf-Control

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersSocial BehaviorBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

March 14, 2007

First Posted

March 15, 2007

Study Start

March 8, 2007

Study Completion

August 5, 2008

Last Updated

July 2, 2017

Record last verified: 2008-08-05

Locations