NCT00071305

Brief Summary

This study will evaluate the magnetoencephalography (MEG) alone and together with electroencephalography (EEG) in non-invasive presurgical evaluation. It will look at the contribution of those methods in determining the location of the epilepsy seizure, compared with doing so through an invasive method. 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. Patients 18 years of age or older who have epilepsy that is not relieved, and who are considered candidates for surgery and who accept epilepsy surgery, may be eligible for this study. Before they have surgery, participants will either sit or lie down, with their 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. Acquiring data from the participant will be conducted during several sessions, each lasting from 10 to 60 minutes, not exceeding a total of 120 minutes. If the first recording is not of sufficient quality, the patient may have it repeated once or twice. Those participants who are found to have a clear seizure focus will proceed directly to surgery that is part of their treatment. Those whose seizure focus is ambiguous will proceed to invasive monitoring. Participants will be followed in the outpatient clinic at intervals of 1, 3, 6, and 12 months. They may periodically undergo reimaging as considered appropriate.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2003

Completed
Same day until next milestone

Study Start

First participant enrolled

October 17, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2003

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2009

Completed
Last Updated

July 2, 2017

Status Verified

October 6, 2009

Enrollment Period

6 years

First QC Date

October 17, 2003

Last Update Submit

June 30, 2017

Conditions

Epilepsy

Keywords

MagnetoencephalographyElectroencephalographyEpilepsyDipole ModelingSurgery

Eligibility Criteria

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

You may qualify if:

  • Patients older than 18 years of age.
  • Patients of both sexes and any race or ethnicity who have intractable epilepsy who are deemed surgical candidates and accept epilepsy surgery.

You may not qualify if:

  • Patients younger than 18 years of age.
  • Pregnant women.
  • Patients who are not surgical candidates.
  • Patients who do not accept epilepsy surgery.
  • Patients with progressive neurological disorders.
  • Patients who are unable to cooperate adequately with MEG/EEG recordings
  • Patients who had brain surgery.
  • Patients unable to understand and sign consent for the study.

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)

  • Amo C, Saldana C, Hidalgo MG, Maestu F, Fernandez A, Arrazola J, Ortiz T. Magnetoencephalographic localization of peritumoral temporal epileptic focus previous surgical resection. Seizure. 2003 Jan;12(1):19-22. doi: 10.1016/s1059131102001486.

    PMID: 12495644BACKGROUND

  • Baumgartner C, Pataraia E, Lindinger G, Deecke L. Neuromagnetic recordings in temporal lobe epilepsy. J Clin Neurophysiol. 2000 Mar;17(2):177-89. doi: 10.1097/00004691-200003000-00007.

    PMID: 10831109BACKGROUND

  • Boon P, D'Have M, Vanrumste B, Van Hoey G, Vonck K, Van Walleghem P, Caemaert J, Achten E, De Reuck J. Ictal source localization in presurgical patients with refractory epilepsy. J Clin Neurophysiol. 2002 Oct;19(5):461-8. doi: 10.1097/00004691-200210000-00009.

    PMID: 12477991BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 17, 2003

First Posted

October 20, 2003

Study Start

October 17, 2003

Primary Completion

October 6, 2009

Last Updated

July 2, 2017

Record last verified: 2009-10-06

Locations

US(1)