NCT00117221

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2005

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2005

Completed
8.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2014

Completed
Last Updated

December 5, 2019

Status Verified

February 11, 2014

First QC Date

July 2, 2005

Last Update Submit

December 4, 2019

Conditions

Keywords

Magnetic Resonance ImagingFunctional ImagingCerebral Blood FlowBOLD EffectSleep

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 15110035BACKGROUND
  • 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.

    PMID: 14964560BACKGROUND
  • 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.

    PMID: 11697939BACKGROUND

Study Officials

  • Jeffrey H Duyn, Ph.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 2, 2005

First Posted

July 4, 2005

Study Start

June 28, 2005

Study Completion

February 11, 2014

Last Updated

December 5, 2019

Record last verified: 2014-02-11

Locations