Brain Activity in People With Functional Movement Disorders
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|ClinicalTrials.gov Identifier: NCT00448084|
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : July 2, 2017
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.
- 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.
|Condition or disease|
|Functional Movement Disorders|
The purpose of this study is to utilize functional MRI (fMRI) to identify structural brain regions and activation patterns involved in deception in order to determine whether illness deception can be differentiated from involuntary conversion disorders. We intend to compare the brain activations of functional movement disorder (FMD) patients against those of healthy volunteers in order to determine whether various aspects of the disorder are under volitional control, suggesting a component of illness deception, or are involuntary as hypothesized in conversion disorders.
We intend to use up to 35 right-hand dominant adult healthy volunteers (the first five subjects will be used to develop this method) and 30 functional movement disorder patients.
Using a slow event-related design, we will scan subjects using a 3T fMRI scanner while they are visually presented with survey-based stimuli which require a yes/no response using a key press. Information used to create the stimuli will be pseudo-randomly derived from one of two databases. The first database will be created from the information garnered in the survey subjects will complete during their screening visit (i.e. subjects eye color or height). The second database will be a collection of non-specific information (i.e. current year, season, etc.) that intentionally does not apply to the subjects. For each question displayed, subjects will receive a visual instruction to respond either truthfully or deceptively. Correct answers to responses will be evaluated based upon the survey the subjects completed. In addition to the BOLD data collected, we plan to calculate reaction times and acquire autonomic data in order to identify possible correlates with the brain responses.
The primary outcome measure is the BOLD-fMRI data collected from subjects while answering yes-no type questions. Secondary outcome measures will include reaction times and autonomic data that will be collected simultaneously with the fMRI data. Standard univariate general linear model analysis will be performed on the fMRI data as well as the use of multivariate methods, including support vector machine learning. Subgroup analyses will be conducted to characterize the correlation between reaction times, autonomic data, and fMRI results as well as potential differences in activation patterns for subject-referenced questions and questions which are unrelated to the subject.
|Study Type :||Observational|
|Enrollment :||65 participants|
|Official Title:||BOLD-fMRI of the Perception of Volition in Functional Movement Disorders|
|Study Start Date :||March 8, 2007|
|Study Completion Date :||August 5, 2008|
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): NCT00448084
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|