Functional Movement DisordersNCT00448084
Brain Activity in People With Functional Movement Disorders
An observational study of Functional Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Movement Disorders
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2007to 5 Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: BOLD-fMRI of the Perception of Volition in Functional Movement Disorders
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:
Read more
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.
Read the 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 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.
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.
- Conditions
- Functional Movement Disorders
- Keywords
- Psychogenic Movement Disorders, Volition, fMRI, Functional MRI, Functional Movement Disorder, Healthy Volunteer, HV
- Medical subject headings
- Conversion Disorder, Self-Control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study start8 Mar 2007
- Study completion5 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Functional Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 65 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448084
- Sponsor's protocol ID
- 070117
- Other IDs
- 07-N-0117
- Status last verified
- 5 Aug 2008
- First submitted
- 14 Mar 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 16032665Bash 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.
PubMed 6930923Cragar 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.
PubMed 16895866
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOLD-fMRI of the Perception of Volition in Functional Movement Disorders
- ClinicalTrials.gov ID
- NCT00448084
- Acronym / sponsor ID
- 070117
- Conditions
- Functional Movement Disorders
- Keywords
- Psychogenic Movement Disorders, Volition, fMRI, Functional MRI, Functional Movement Disorder, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 8 Mar 2007
- Study completion
- 5 Aug 2008
- First posted
- 15 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
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 design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Age 18 to 65
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 16032665Barry 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.
- Background: PubMed 6930923Bash 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.
- Background: PubMed 16895866Cragar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00448084, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.