Terminé

MRI Measurement of Brain Metabolism Across the Sleep-Wake Cycle

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Ce qui est collecté

Collecte de données

Qui peut participer

De 18 à 65 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Observationnel
Date de début : juin 2005
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Neurological Disorders and Stroke (NINDS)
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 28 juin 2005

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielMRI Measurement of Brain Metabolism Across the Sleep-Wake Cycle
NCT00117221
Sponsor principalNational Institute of Neurological Disorders and Stroke (NINDS)
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

56 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 65 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Critères

* 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.

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOuvrir National Institutes of Health Clinical Center, 9000 Rockville Pike dans Google Maps
Terminé1 Centres d'Étude