Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246831
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-10-29
Brief Title:
Brain Networks Responsible for Self-Agency
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Brain Networks Responsible for Self-Agency An fMRI Study
Status:
COMPLETED
Status Verified Date:
2008-10-28
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 examine how people consider their actions to be under their own control or not The term to describe this feeling of being in control of ones own actions is called agency The sense of agency becomes impaired in disorders such as schizophrenia in which people may feel for example as if someone else is controlling their thoughts
Healthy right-handed normal volunteers 18 years of age and older may be eligible for this study Candidates are screened with a medical history neurological examination pregnancy test for women of childbearing age and magnetic resonance imaging MRI scan MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues During the procedure the subject lies on a table that can slide in and out of the scanner a metal cylinder surrounded by a magnetic field and may be asked to lie still for up to 30 minutes at a time
Participants undergo functional MRI fMRI This procedure is the same as a regular MRI except it is done while the subject performs tasks This enables researchers to learn about changes in brain regions involved in those tasks The fMRI scan for this study takes about 90 minutes
Before beginning the fMRI procedure subjects receive training using a Cyber glove device This device allows the researchers to measure the subjects finger movements and display them on a screen for the subject to view The subjects are asked to make hand movements by slowly opening and closing the hand while watching the computer displaying an artificial hand During the movements the subjects level of control is adjusted and they are asked to describe how much control they think they have over the hand on the screen When the subjects become comfortable using the Cyber glove they enter the MRI scanner to begin the test scan
For the fMRI subjects are given visual instruction on when to begin opening and closing their right hand They move continuously for a 30-second block and then have a 20-second rest period This is repeated with subjects provided different levels of control over the displayed hand in each block The entire test consists of four runs each run consisting of 12 blocks lasting about 10 minutes When the fMRI scanning is finished the brain is scanned once more using regular MRI
Healthy right-handed normal volunteers 18 years of age and older may be eligible for this study Candidates are screened with a medical history neurological examination pregnancy test for women of childbearing age and magnetic resonance imaging MRI scan MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues During the procedure the subject lies on a table that can slide in and out of the scanner a metal cylinder surrounded by a magnetic field and may be asked to lie still for up to 30 minutes at a time
Participants undergo functional MRI fMRI This procedure is the same as a regular MRI except it is done while the subject performs tasks This enables researchers to learn about changes in brain regions involved in those tasks The fMRI scan for this study takes about 90 minutes
Before beginning the fMRI procedure subjects receive training using a Cyber glove device This device allows the researchers to measure the subjects finger movements and display them on a screen for the subject to view The subjects are asked to make hand movements by slowly opening and closing the hand while watching the computer displaying an artificial hand During the movements the subjects level of control is adjusted and they are asked to describe how much control they think they have over the hand on the screen When the subjects become comfortable using the Cyber glove they enter the MRI scanner to begin the test scan
For the fMRI subjects are given visual instruction on when to begin opening and closing their right hand They move continuously for a 30-second block and then have a 20-second rest period This is repeated with subjects provided different levels of control over the displayed hand in each block The entire test consists of four runs each run consisting of 12 blocks lasting about 10 minutes When the fMRI scanning is finished the brain is scanned once more using regular MRI
Detailed Description:
OBJECTIVE
The purpose of this study is to identify structural brain regions using a block design blood oxygenation level-dependent functional magnetic resonance imaging BOLD-fMRI which are differentially activated based on the sense of self-agency felt by making simple finger movements We will compare the activations of healthy volunteers with patients diagnosed with a functional movement disorder FMD who we hypothesize will have an impaired sense of volition
STUDY POPULATION
We intend to use 25 right-hand dominant adult healthy volunteers for comparison with 50 patients diagnosed with a FMD We also wish to study an additinal 5 patients witha complete or near-complete sensory neuropathy
DESIGN
The sense of self-agency SA will be modulated using a visual task-based stimulus asking subjects to manipulate the position of an artificial hand projected onto a display in the magnetic resonance imaging MRI scanner Subjects will use their own right hand to make slow sequential finger movements which will be represented visually with the aid of a Cyberglove During a behavioral training phase subjects will practice using the apparatus The level of control will be randomly changed to one of five states 100 control 75 50 25 or randomno control After subjects are comfortable with the apparatus and endorse SA over the displayed hand they will undergo fMRI scanning FMD patients who do not wish to participate in the fMRI portion of the study may still participate in the behavioral testing portion
The imaging phase of the experiment will have five sets of 6 minute scanning sessions where the subject is instructed to slowly open and close sequential fingers of their right hand The level of control will be changed pseudo-randomly throughout the scan sessions A control contrast consisting of the subject observing a moving hand will also be integrated into the blocks An additional control contrast involving the subject moving their hand without visual feedback will also be included These contrasts will serve in the analysis phase to help eliminate hemodynamic activity related to visual-motor feedback At the completion of fMRI scanning a baseline high-resolution MRI T1 scan will be obtained for anatomic localization and co-registration At the completion of the imaging portion subjects will also be asked to report the percentage of control they subjectively feel over the displayed hand using a final data set for behavioral testing
OUTCOME MEASURES
The primary outcome of this study is the difference in activation of brain structures in response to a loss of SA between FMD patients sensory neuropathy patients and healthy controls In particular we are interested in the presence of any differential activation in the dorsolateral prefrontal cortex insula inferior parietal lobes pre-supplementary motor association cortex pre-SMA andor the anterior cingulate which may occur as SA is increased or decreased A secondary analysis will utilize the individual subject perceptions of percent control during the behavioral training phase as the regressors for activation rather than the objective control settings
The purpose of this study is to identify structural brain regions using a block design blood oxygenation level-dependent functional magnetic resonance imaging BOLD-fMRI which are differentially activated based on the sense of self-agency felt by making simple finger movements We will compare the activations of healthy volunteers with patients diagnosed with a functional movement disorder FMD who we hypothesize will have an impaired sense of volition
STUDY POPULATION
We intend to use 25 right-hand dominant adult healthy volunteers for comparison with 50 patients diagnosed with a FMD We also wish to study an additinal 5 patients witha complete or near-complete sensory neuropathy
DESIGN
The sense of self-agency SA will be modulated using a visual task-based stimulus asking subjects to manipulate the position of an artificial hand projected onto a display in the magnetic resonance imaging MRI scanner Subjects will use their own right hand to make slow sequential finger movements which will be represented visually with the aid of a Cyberglove During a behavioral training phase subjects will practice using the apparatus The level of control will be randomly changed to one of five states 100 control 75 50 25 or randomno control After subjects are comfortable with the apparatus and endorse SA over the displayed hand they will undergo fMRI scanning FMD patients who do not wish to participate in the fMRI portion of the study may still participate in the behavioral testing portion
The imaging phase of the experiment will have five sets of 6 minute scanning sessions where the subject is instructed to slowly open and close sequential fingers of their right hand The level of control will be changed pseudo-randomly throughout the scan sessions A control contrast consisting of the subject observing a moving hand will also be integrated into the blocks An additional control contrast involving the subject moving their hand without visual feedback will also be included These contrasts will serve in the analysis phase to help eliminate hemodynamic activity related to visual-motor feedback At the completion of fMRI scanning a baseline high-resolution MRI T1 scan will be obtained for anatomic localization and co-registration At the completion of the imaging portion subjects will also be asked to report the percentage of control they subjectively feel over the displayed hand using a final data set for behavioral testing
OUTCOME MEASURES
The primary outcome of this study is the difference in activation of brain structures in response to a loss of SA between FMD patients sensory neuropathy patients and healthy controls In particular we are interested in the presence of any differential activation in the dorsolateral prefrontal cortex insula inferior parietal lobes pre-supplementary motor association cortex pre-SMA andor the anterior cingulate which may occur as SA is increased or decreased A secondary analysis will utilize the individual subject perceptions of percent control during the behavioral training phase as the regressors for activation rather than the objective control settings
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 |
|---|---|---|---|
| 06-N-0023 | None | None | None |