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Magnetoencephalography in Absence Seizures
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), April 2009
First Received: April 17, 2009   Last Updated: July 11, 2009   History of Changes
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00884351
  Purpose

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.

Condition
Seizures

Study Type: Observational
Study Design: Prospective
Official Title: Magnetoencephalography in Absence Seizures

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 33
Study Start Date: April 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884351

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 090125, 09-N-0125
Study First Received: April 17, 2009
Last Updated: July 11, 2009
ClinicalTrials.gov Identifier: NCT00884351     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Epilepsy
MEG
Epilepsy
Seizures

Study placed in the following topic categories:
Signs and Symptoms
Epilepsy
Epilepsy, Absence
Seizures
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases
Epilepsy, Generalized

Additional relevant MeSH terms:
Signs and Symptoms
Epilepsy
Nervous System Diseases
Seizures
Epilepsy, Absence
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases
Epilepsy, Generalized

ClinicalTrials.gov processed this record on August 24, 2009