Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448084
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-03-14
Brief Title:
Brain Activity in People With Functional Movement Disorders
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
BOLD-fMRI of the Perception of Volition in Functional Movement Disorders
Status:
COMPLETED
Status Verified Date:
2008-08-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects 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
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 subjects 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
Detailed Description:
OBJECTIVE
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
STUDY POPULATION
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
DESIGN
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 yesno 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 ie subjects eye color or height The second database will be a collection of non-specific information ie 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
OUTCOME MEASURES
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
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
STUDY POPULATION
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
DESIGN
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 yesno 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 ie subjects eye color or height The second database will be a collection of non-specific information ie 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
OUTCOME MEASURES
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-N-0117 | None | None | None |