Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117221
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2005-07-02
Brief Title:
MRI Measurement of Brain Metabolism Across the Sleep-Wake Cycle
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
MRI Measurement of Brain Metabolism Across the Sleep-Wake Cycle
Status:
COMPLETED
Status Verified Date:
2014-02-11
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 investigate the spatio-temporal characteristics of brain activity during sleep Functional magnetic resonance imaging fMRI studies have shown that in the absence of external stimuli the brain continues to show spatial patterns of activity that resemble those during sensory and cognitive tasks This phenomenon greatly affects the interpretation of neuroimaging studies based on positive emission tomography PET and fMRI which rely on the contrast between brain activity during a task and activity during rest In addition resting state activity in itself may reveal information on the large-scale organization of neuronal networks and on functional abnormalities related to disease
Participants should represent a broad cross section of the healthy adult population Any neurologically and psychiatrically healthy male or nonpregnant female between 18 and 65 years old may be eligible
Studies will be conducted in the In Vivo NMR Research Center Concurrent electroencephalogram EEG and MRI studies will last between 1 and 2 hours A typical study involves 15 minutes of anatomical MRI scanning followed by a 60-minute functional scan during which the subject relaxes with eyes closed and is encouraged to sleep while the fMRIEEG are performed Participants may be scanned 1 to 20 times No more than 1 scan will be performed per day and no more than 20 scans will be performed within a year During the last 5 to 10 minutes of the scan the participant will open his or her eyes and actively participate in a visual stimulation or attention task The participants alertness will be measured by a behavioral button-press response The visual stimuli contrast reversing checkerboard displays alternated with uniform grey fields will be presented using the standard projection system available with the MRI scanner The attention task will involve repeated visual presentation of groups of letters and digits the participant will be asked about the correspondence between these groups
Magnetoencephalogram MEG scans will be performed on some participants The precise and undistorted signals available with MEG will be used to enhance the interpretation of alertness and sleep-related characteristics of the EEG signals which can vary quite dramatically across subjects In addition the MEG signals will provide preliminary spatial localization of the sleep-dependent changes more precisely than is possible with EEG MRI scanner noise will be simulated using tape recordings to allow comparison with the MRIEEG data MEG scans will last 45 minutes to 2 hours At all times during any of the brain scans the participant will be able to communicate the MRI scientist or MEGEEG technician and can ask to be removed from the device at any time
The study will not have a direct benefit for participants It may be help us learn more about brain function which may lead to better treatments
Participants should represent a broad cross section of the healthy adult population Any neurologically and psychiatrically healthy male or nonpregnant female between 18 and 65 years old may be eligible
Studies will be conducted in the In Vivo NMR Research Center Concurrent electroencephalogram EEG and MRI studies will last between 1 and 2 hours A typical study involves 15 minutes of anatomical MRI scanning followed by a 60-minute functional scan during which the subject relaxes with eyes closed and is encouraged to sleep while the fMRIEEG are performed Participants may be scanned 1 to 20 times No more than 1 scan will be performed per day and no more than 20 scans will be performed within a year During the last 5 to 10 minutes of the scan the participant will open his or her eyes and actively participate in a visual stimulation or attention task The participants alertness will be measured by a behavioral button-press response The visual stimuli contrast reversing checkerboard displays alternated with uniform grey fields will be presented using the standard projection system available with the MRI scanner The attention task will involve repeated visual presentation of groups of letters and digits the participant will be asked about the correspondence between these groups
Magnetoencephalogram MEG scans will be performed on some participants The precise and undistorted signals available with MEG will be used to enhance the interpretation of alertness and sleep-related characteristics of the EEG signals which can vary quite dramatically across subjects In addition the MEG signals will provide preliminary spatial localization of the sleep-dependent changes more precisely than is possible with EEG MRI scanner noise will be simulated using tape recordings to allow comparison with the MRIEEG data MEG scans will last 45 minutes to 2 hours At all times during any of the brain scans the participant will be able to communicate the MRI scientist or MEGEEG technician and can ask to be removed from the device at any time
The study will not have a direct benefit for participants It may be help us learn more about brain function which may lead to better treatments
Detailed Description:
Objective The objective of the proposed study is to investigate the spatio-temporal characteristics of brain activity during sleep A number of recent fMRI Ogawa Lee et al 1990 studies have shown that in absence of external stimuli the brain continues to show spatial patterns of activity that resemble the networks that activate during sensory and cognitive tasks This phenomenon greatly affects the interpretation of neuroimaging studies based on PET and fMRI since these rely on differential imaging in which activity during a task is contrasted against activity during rest In addition resting state activity in itself potentially contains unique information on the large scale organization of neuronal networks and reveals information about functional abnormalities related to disease processes
Study Population To avoid confounding factors related to disease processes subjects for this study will be recruited from the normal adult population In addition subjects will be screened for sleep behavior and subjects with abnormal sleep behavior will be excluded
Design The study is designed to facilitate MRI detection of cerebral metabolic differences between the sleep and awake states Wakefulness and sleep and the various stages will be classified in accordance with the EEG criteria consistent with the guidelines of Rechtschaffen and Kales Rechtschaffen 1968 For this purpose we will optimize the methodology for the concurrent acquisition of EEG and fMRI signals Using concurrent EEG and state-of-the-art MRI we plan to establish the precise spatial distribution of changes in brain activity that are associated with changes in the sleepwake state and the various stages of sleep specifically early sleep stage 1 and 2 Secondly we plan to investigate whether changes in regional brain metabolism as measured by MRI correlates with transitory EEG phenomena during sleep including fluctuations in band-specific power sleep spindles and K-complexes
Outcome Measure As an outcome of this study an atlas of activity clusters in normal subjects will be established both during waking conditions as well as during several sleep stages Further outcomes will be spatial patterns of covariance with EEG band-specific power spindles and K-complexes These data will serve as a baseline for comparison with activity patterns in patients
Study Population To avoid confounding factors related to disease processes subjects for this study will be recruited from the normal adult population In addition subjects will be screened for sleep behavior and subjects with abnormal sleep behavior will be excluded
Design The study is designed to facilitate MRI detection of cerebral metabolic differences between the sleep and awake states Wakefulness and sleep and the various stages will be classified in accordance with the EEG criteria consistent with the guidelines of Rechtschaffen and Kales Rechtschaffen 1968 For this purpose we will optimize the methodology for the concurrent acquisition of EEG and fMRI signals Using concurrent EEG and state-of-the-art MRI we plan to establish the precise spatial distribution of changes in brain activity that are associated with changes in the sleepwake state and the various stages of sleep specifically early sleep stage 1 and 2 Secondly we plan to investigate whether changes in regional brain metabolism as measured by MRI correlates with transitory EEG phenomena during sleep including fluctuations in band-specific power sleep spindles and K-complexes
Outcome Measure As an outcome of this study an atlas of activity clusters in normal subjects will be established both during waking conditions as well as during several sleep stages Further outcomes will be spatial patterns of covariance with EEG band-specific power spindles and K-complexes These data will serve as a baseline for comparison with activity patterns in patients
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 |
|---|---|---|---|
| 05-N-0179 | None | None | None |