NCT00071370

Brief Summary

This study will evaluate how the state of being completely deprived of sleep has an effect on recordings of magnetoencephalography (MEG) and electroencephalography (EEG), in relation to how alert someone is and how sleepy someone perceives himself or herself to be. EEG measures electronic potential differences on the scalp. On the other hand, MEG is a non-invasive technique for recording the activity of neurons in the brain, through recording of magnetic fields caused by synchronized neural currents. It has the ability to detect seizures. Because magnetic signals of the brain vary, this technique must balance two key problems: weakness of the signal and strength of the noise. The EEG is sensitive to extra-cellular volume currents, whereas the MEG primarily registers intra-cellular currents. Because electrical fields are quite dependent on the conductive properties of the tissues, and magnetic fields are significantly less distorted by tissue, the MEG has better spatial resolution. There is a great deal of evidence that EEG and MEG provide complementary data about underlying currents of ions. The complex relationship of sleep and epilepsy is well known. Sleep has been used for many years as a powerful EEG activator. Many researchers have supported the hypothesis that there is a specific activating effect of sleep deprivation on epileptic discharges. Sleep deprivation is defined as a sleepless state of longer than 24 hours. The increased use of MEG in diagnosis could improve the procedure for evaluating patients before surgery for epilepsy, by making invasive studies less necessary. Patients 18 years of age or older, with a diagnosis of epilepsy and with a documented last routine EEG (at least 2 weeks earlier) and routine EEG on the day of a baseline MEG-EEG without interictal epileptiform discharges (IEDs) may be eligible for this study. Participants will be rated according to the Epworth, Stanford, and Karolinska Sleepiness Scales, to determine their subjective sleepiness. They will be randomly assigned to stay awake all night or sleep in the hospital overnight. That is, a sleep deprivation and non-sleep deprivation synchronized MEG-EEG recording will be performed in random order. Then the sequence of sleep deprivation and non-sleep deprivation will be reversed within 14 to 21 days. During the recordings, the patient will either sit or lie with his or her head in a helmet covering the entire head, with openings for the eyes and ears. Brain magnetic fields will be recorded with a 275-channel OMEGA system. Throughout the session, visual and two-way audio communication will be maintained with the patient. Recording sessions will last 90 to 180 minutes, with the patient allowed to take breaks after at least 10 minutes in a scanner. Attempts will be made to encourage patients to stay awake and sleep for about the same amount of time during each recording, to acquire comparable amounts of sleep and awake recordings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2003

Typical duration 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

October 1, 2003

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2003

Completed
Same day until next milestone

First Posted

Study publicly available on registry

October 20, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 2005

First QC Date

October 20, 2003

Last Update Submit

March 3, 2008

Conditions

Keywords

MagnetoencephalographyElectroencephalogram (EEG)Interictal Epileptiform DischargesEpilepsySleep DeprivationSeizure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years or older
  • Patients of both sexes and of any race or ethnicity who have a diagnosis of epilepsy routine EEG on the day of a baseline MEG-EEG without IEDs.

You may not qualify if:

  • Patients younger than 18 years
  • Patients with progressive neurological disorders
  • Patients who are unable to lie still or cooperate adequately with MRI or MEG/EEG
  • Patients who are unable to sustain the required degree of sleep deprivation.
  • Patients who have had brain surgery.
  • Patients unable to sign and understand the study consent
  • Patients with IEDs on a routine EEG
  • Patients with IEDs on the baseline MEG-EEG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Dinner DS. Effect of sleep on epilepsy. J Clin Neurophysiol. 2002 Dec;19(6):504-13. doi: 10.1097/00004691-200212000-00003.

    PMID: 12488781BACKGROUND
  • Brockhaus A, Lehnertz K, Wienbruch C, Kowalik A, Burr W, Elbert T, Hoke M, Elger CE. Possibilities and limitations of magnetic source imaging of methohexital-induced epileptiform patterns in temporal lobe epilepsy patients. Electroencephalogr Clin Neurophysiol. 1997 May;102(5):423-36. doi: 10.1016/s0921-884x(97)96625-x.

    PMID: 9191586BACKGROUND
  • el-Ad B, Neufeld MY, Korczyn AD. Should sleep EEG record always be performed after sleep deprivation? Electroencephalogr Clin Neurophysiol. 1994 Apr;90(4):313-5. doi: 10.1016/0013-4694(94)90150-3.

    PMID: 7512913BACKGROUND

MeSH Terms

Conditions

EpilepsySleep DeprivationSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesDyssomniasSleep Wake DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 20, 2003

First Posted

October 20, 2003

Study Start

October 1, 2003

Study Completion

November 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-11

Locations