MRI Measurement of Brain Metabolism Across the Sleep-Wake Cycle
Data Collection
Summary
Study start date: June 28, 2005
Actual date on which the first participant was enrolled.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 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.56 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
* INCLUSION CRITERIA: Any neurologically and psychiatrically normal, male or female, healthy volunteer between 18 and 65 years old is in principle eligible for the study. Subjects must be capable of understanding the procedures and requirements of this study. Subjects must be willing to sign an informed consent document. EXCLUSION CRITERIA: A subject will be excluded if he/she has a contraindication to MR scanning such as the following: pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; known absent acoustic reflex; ocular foreign body (e.g. metal shavings or insulin pump) and any pre-existing eye conditions. Subjects who underwent brain surgery, who have a neurological lesion, a psychiatric history or recurrent migraines that require medication will also be excluded from this study. 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. Exclusion criteria include: 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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps