Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397111
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2006-11-07
Brief Title:
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Development of Functional and Structural Magnetic Resonance Imaging Techniques for the Study of Mood and Anxiety Disorders
Status:
RECRUITING
Status Verified Date:
2024-09-19
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 is intended to help develop new MRI imaging techniques for studying mood and anxiety disorders Researchers believe that depression and anxiety disorders may cause structural and functional changes in the brain This study will optimize the way MRI scans are collected to look at brain structure and examine how the brain behaves while subjects perform particular tasks Healthy volunteers and individuals with major depressive disorder may be eligible for this study
Participants undergo magnetic resonance imaging MRI and neuropsychological testing Individuals will be asked to participate in an MRI study on one of several scanners The scanner used will measure blood flow in the brain concentrations of certain chemicals in the brain or magnetic properties of the brain The scan may involve They watching a screen presenting images or doing a task in which they respond to pictures or sounds Participants may be asked to return for additional scans
The study also involves neuropsychological tests which assess cognitive performance Often people with mood disorders have subtle changes in performance on these tests that allow researchers to pinpoint where brain abnormalities occur Before the tests can be used in patients they must be validated by using healthy subjects These tests are presented either orally in written form or on a computer
Participants undergo magnetic resonance imaging MRI and neuropsychological testing Individuals will be asked to participate in an MRI study on one of several scanners The scanner used will measure blood flow in the brain concentrations of certain chemicals in the brain or magnetic properties of the brain The scan may involve They watching a screen presenting images or doing a task in which they respond to pictures or sounds Participants may be asked to return for additional scans
The study also involves neuropsychological tests which assess cognitive performance Often people with mood disorders have subtle changes in performance on these tests that allow researchers to pinpoint where brain abnormalities occur Before the tests can be used in patients they must be validated by using healthy subjects These tests are presented either orally in written form or on a computer
Detailed Description:
Objective
A major component of understanding the pathogenesis of mood and anxiety disorders is expected to involve elucidation of abnormalities in brain structure and function associated with these conditions Historically post-mortem histopathological and neurochemical assessments constituted the primary methods for investigating abnormalities of brain structure and function in psychiatric disorders However the significance of the results from such studies has been limited by the relatively poor availability of specimens from subjects with mood and anxiety disorders who had been unmedicated and clinically well-characterized antemortem By allowing for in vivo human studies medical imaging technologies provide efficient accurate and non-invasive alternatives for characterizing brain structure and function The recent rapid development of magnetic resonance imaging MRI technology in particular has provided powerful tools for assessing a wide range of cerebral physiological and morphological characteristics To optimally exploit the potential of these rapidly evolving MRI scanning and hardware capabilities in investigations of mood and anxiety disorders new techniques and applications must be developed and tested The technical development protocol proposed herein will assess new imaging techniques and hardware and will develop novel cognitive tasks for application in the study of mood and anxiety disorders The primary objective of this protocol is the development of MRI experiments for characterizing the physiological correlates of mood and anxiety disorders In addition the pilot projects encompassed within this protocol involve the optimization of existing MRI pulse sequences the application of new pulse sequences for structural and functional MR imaging and the development of new functional MRI fMRI tasks that can elucidate neural function within the cognitive-behavioral domains affected in mood and anxiety disorders This protocol will also allow testing of existing imaging hardware that can increase the spatial resolution contrast and sensitivity of MR images Such hardware includes the use of multi-channel radio frequency RF coils and patient monitoring equipment Development of these techniques and applications will directly enhance the sensitivity and specificity of MRI studies of mood and anxiety disorders
Study Population
This study will involve 250 healthy volunteers and 90 patients with major depressive disorder
Design
This technical development protocol will assess new imaging techniques and hardware and will develop novel cognitive tasks for application in the study of mood and anxiety disorders Subjects will have the option to participate in one or several procedures conducted under this protocol including fMRI Magnetic Resonance Spectroscopy MRS Magnetoencephalography MEG behavioral tasks and rating scales
Outcome Measures
Primary outcome measures on neuropsychological tests will include parameters such as accuracy and reaction time Secondary outcome measures will include differences in reaction time or accuracy between different testing conditions Outcome measures from MRI scanning sessions will include signal-to-noise ratio contrast-to-noise ratio structural volumes metabolite concentrations in the case of MRS relaxation times in the case of relaxometry and BOLD time series in the case of fMRI
A major component of understanding the pathogenesis of mood and anxiety disorders is expected to involve elucidation of abnormalities in brain structure and function associated with these conditions Historically post-mortem histopathological and neurochemical assessments constituted the primary methods for investigating abnormalities of brain structure and function in psychiatric disorders However the significance of the results from such studies has been limited by the relatively poor availability of specimens from subjects with mood and anxiety disorders who had been unmedicated and clinically well-characterized antemortem By allowing for in vivo human studies medical imaging technologies provide efficient accurate and non-invasive alternatives for characterizing brain structure and function The recent rapid development of magnetic resonance imaging MRI technology in particular has provided powerful tools for assessing a wide range of cerebral physiological and morphological characteristics To optimally exploit the potential of these rapidly evolving MRI scanning and hardware capabilities in investigations of mood and anxiety disorders new techniques and applications must be developed and tested The technical development protocol proposed herein will assess new imaging techniques and hardware and will develop novel cognitive tasks for application in the study of mood and anxiety disorders The primary objective of this protocol is the development of MRI experiments for characterizing the physiological correlates of mood and anxiety disorders In addition the pilot projects encompassed within this protocol involve the optimization of existing MRI pulse sequences the application of new pulse sequences for structural and functional MR imaging and the development of new functional MRI fMRI tasks that can elucidate neural function within the cognitive-behavioral domains affected in mood and anxiety disorders This protocol will also allow testing of existing imaging hardware that can increase the spatial resolution contrast and sensitivity of MR images Such hardware includes the use of multi-channel radio frequency RF coils and patient monitoring equipment Development of these techniques and applications will directly enhance the sensitivity and specificity of MRI studies of mood and anxiety disorders
Study Population
This study will involve 250 healthy volunteers and 90 patients with major depressive disorder
Design
This technical development protocol will assess new imaging techniques and hardware and will develop novel cognitive tasks for application in the study of mood and anxiety disorders Subjects will have the option to participate in one or several procedures conducted under this protocol including fMRI Magnetic Resonance Spectroscopy MRS Magnetoencephalography MEG behavioral tasks and rating scales
Outcome Measures
Primary outcome measures on neuropsychological tests will include parameters such as accuracy and reaction time Secondary outcome measures will include differences in reaction time or accuracy between different testing conditions Outcome measures from MRI scanning sessions will include signal-to-noise ratio contrast-to-noise ratio structural volumes metabolite concentrations in the case of MRS relaxation times in the case of relaxometry and BOLD time series in the case of fMRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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-M-0021 | None | None | None |