MRI Measurement of Brain Metabolism Across the Sleep-Wake Cycle
NCT ID: NCT00117221
Last Updated: 2019-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
56 participants
OBSERVATIONAL
2005-06-28
2014-02-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 fMRI/EEG 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 participant's 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 MRI/EEG 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 MEG/EEG 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
NCT02629107
Human Brain Mapping of the Apparent Diffusion Coefficient (ADC) During Sleep and Wakefulness
NCT02311374
Cerebral MRI During Sleep
NCT03304652
Quantitation of Glymphatic Functioning in Sleep and Meditative States
NCT04506892
MRI Neurofeedback and Brain Circuits Related to Motivation in Healthy Participants
NCT05929898
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 sleep/wake 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
To minimize potential confounds, subjects with abnormal sleep/wake patterns will be excluded. They should report no sleep problems or shift work, or medications that could impair sleep, no illegal drugs or tobacco. Subjects will be in good health as assessed by medical history, interview and physical exam.
Subjects will be asked to:
Refrain from alcohol and caffeinated products for 1 day prior to the study;
Maintain their habitual bed times and wake-up times for 1 week prior to the study. A wrist-worn activity monitor (Actigraph\[R\], Precision Control Design, Inc., Fort Walton Beach, FL) may be used to confirm compliance with the latter instruction.
Sleep disorder (reported or detected);
Psychopathology, personal or first-degree relative. (They are likely to place the subject at risk for an adverse consequence related to the extended wakefulness portion of the study);
Seizures or head injury with loss of consciousness greater than 5 minutes;
Substance dependence (diagnosable);
Smoking tobacco or psychotropic medications (currently);
Caffeine consumption of 300 mg or 2 ounces of alcohol on a regular daily consumption;
Cardiac, respiratory, or other medical condition that may affect cerebral metabolism.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey H Duyn, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bartels A, Zeki S. The chronoarchitecture of the human brain--natural viewing conditions reveal a time-based anatomy of the brain. Neuroimage. 2004 May;22(1):419-33. doi: 10.1016/j.neuroimage.2004.01.007.
Beckmann CF, Smith SM. Probabilistic independent component analysis for functional magnetic resonance imaging. IEEE Trans Med Imaging. 2004 Feb;23(2):137-52. doi: 10.1109/TMI.2003.822821.
Calhoun VD, Adali T, McGinty VB, Pekar JJ, Watson TD, Pearlson GD. fMRI activation in a visual-perception task: network of areas detected using the general linear model and independent components analysis. Neuroimage. 2001 Nov;14(5):1080-8. doi: 10.1006/nimg.2001.0921.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
05-N-0179
Identifier Type: -
Identifier Source: secondary_id
050179
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.