NCT00884351

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2009

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

April 15, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2011

Completed
Last Updated

July 2, 2017

Status Verified

June 15, 2011

First QC Date

April 17, 2009

Last Update Submit

June 30, 2017

Conditions

Keywords

EpilepsyMEGSeizures

Eligibility Criteria

Age7 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 7-35
  • 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.
  • Patients who have other neurologic disorders may be included, as long as they are able to consent/assent.

You may not qualify if:

  • Contraindications to MEG studies (Dental braces, permanent retainers, metal dental caps/crowns/fillings)
  • Contraindications to MRI studies (such as pacemakers, cochlear devices, surgical clips, metallic implants, orthopedic pins, shrapnel, permanent eyeliner, vagus nerve stimulator)
  • Claustrophobia or anxiety disorders exacerbated by MRI
  • Pregnancy
  • Inability to provide consent/assent

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)

  • Avoli M, Gloor P. Role of the thalamus in generalized penicillin epilepsy: observations on decorticated cats. Exp Neurol. 1982 Aug;77(2):386-402. doi: 10.1016/0014-4886(82)90252-7. No abstract available.

    PMID: 7095066BACKGROUND
  • Bernasconi A, Bernasconi N, Natsume J, Antel SB, Andermann F, Arnold DL. Magnetic resonance spectroscopy and imaging of the thalamus in idiopathic generalized epilepsy. Brain. 2003 Nov;126(Pt 11):2447-54. doi: 10.1093/brain/awg249. Epub 2003 Aug 5.

    PMID: 12902313BACKGROUND
  • Castro-Alamancos MA. Neocortical synchronized oscillations induced by thalamic disinhibition in vivo. J Neurosci. 1999 Sep 15;19(18):RC27. doi: 10.1523/JNEUROSCI.19-18-j0005.1999.

    PMID: 10479720BACKGROUND

MeSH Terms

Conditions

SeizuresEpilepsy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

April 15, 2009

Study Completion

June 15, 2011

Last Updated

July 2, 2017

Record last verified: 2011-06-15

Locations