Magnetoencephalography in Absence Seizures

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00884351
First received: April 17, 2009
Last updated: June 16, 2011
Last verified: June 2011

April 17, 2009
June 16, 2011
April 2009
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Complete list of historical versions of study NCT00884351 on ClinicalTrials.gov Archive Site
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Magnetoencephalography in Absence Seizures
Magnetoencephalography in Absence Seizures

Background:

  • An absence seizure is a type of seizure that usually begins in childhood and goes away by early adulthood. Scientists do not yet know where absence seizures begin in the brain. Some evidence suggests that these seizures begin in the thalamus, a structure deep in the brain, but other studies suggest that they begin in the frontal cortex, at the front part of the brain.
  • Magnetoencephalography is a type of brain scanning procedure that is useful in determining information about what happens to the brain during epileptic seizures. Understanding where absence seizures come from may help doctors find new treatments for them.

Objectives:

  • To gain a better understanding of which parts of the brain are affected in absence seizures.

Eligibility:

  • Patients 7 to 35 years of age who have been diagnosed with absence seizures.

Design:

  • Procedures are for research purposes only, not to diagnose or treat a particular medical condition.
  • Two outpatient visits to the National Institutes of Health Clinical Center: evaluation and scanning.
  • Researchers will evaluate potential participants with a medical history, physical examination, and electroencephalography (EEG). These tests will be performed under another protocol, 01-N-0139.
  • Patients will undergo magnetoencephalography (MEG) and magnetic resonance imaging (MRI) of the brain. The study procedures will be performed one time; however, an MEG or MRI scan may need to be repeated for technical reasons. Researchers will not do more than two MEG or MRI scans.
  • The MEG will record very small magnetic field changes produced by the activity of the brain. An EEG will be recorded at the same time as the MEG.
  • The MRI will use a magnetic field to take pictures of the inside of the brain.
  • The MEG will take 3 hours to complete (2 hours for preparation, 1 hour in the scanner). The MRI will take approximately 1 hour.

Objective:

This protocol will test the hypothesis that the 3-Hz spike-wave discharges seen in absence epilepsy originate in the thalamus. We will use an emerging modality, magnetoencephalograpy (MEG), to test this hypothesis.

Study Population:

33 patients with absence seizures.

Design:

This is a non-invasive imaging study that involves a 275-channel whole head MEG recording and a structural MRI for co-registration of MEG data.

Outcome Measure:

The primary outcome measure is the source localization of spike-wave discharges on magnetoencephalography.

Observational
Time Perspective: Prospective
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Seizures
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
June 2011
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  • INCLUSION CRITERIA:

    1. Age 7-35
    2. Absence of seizures based on clinical and electroenecephalography data. Patients who have other seizure types (myoclonic, generalized tonic-clonic) in addition to absence seizures may be included.
    3. Patients who have other neurologic disorders may be included, as long as they are able to consent/assent.

EXCLUSION CRITERIA:

  1. Contraindications to MEG studies (Dental braces, permanent retainers, metal dental caps/crowns/fillings)
  2. Contraindications to MRI studies (such as pacemakers, cochlear devices, surgical clips, metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator)
  3. Claustrophobia or anxiety disorders exacerbated by MRI
  4. Pregnancy
  5. Inability to provide consent/assent
Both
7 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00884351
090125, 09-N-0125
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National Institute of Neurological Disorders and Stroke (NINDS)
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National Institutes of Health Clinical Center (CC)
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP