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CompletedNCT01090934EEG-HRUpdated Jan 27, 2016

Localizing the Epileptogenic Zone With High Resolution Electroencephalography

An interventional study of High Resolution EEG and Stereo-electroencephalography in Partial Epilepsy, sponsored by Central Hospital, Nancy, France. Completed at 2 sites in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-01-27.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Non-randomized
Ages
15 Years and older
Sex
All
01

Study summary

Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.

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Conditions studied

  • Partial Epilepsy

Keywords

  • Diagnosis
  • Partial Epilepsy
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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 115 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • medically intractable patial epilepsy confirmed by video-EEG recordings of epileptic seizures.
  • Depth EEG (Stereo-EEG) required to delineate the epileptogenic zone and define the surgical procedure.
  • full informed consent of the patient (or of his/ her legal representative)
  • 15 year or older patient

Exclusion criteria

Exclusion Criteria:

  • contraindication to cortectomy
  • contraindication to depth-EEG
  • indication of epilepsy surgery without depth-EEG monitoring

  • high grade glioma, arterio-veinous malformations

    • pregnancy
    • history of severe cardio-vascular event (coronaropathy, stroke)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
115 participants (actual)

Study arms

  • Experimental
    high resolution EEG

    Device: High Resolution EEG

  • Active comparator
    Stereo Electroencephalography

    Device: Stereo-electroencephalography

Interventions

  • DeviceHigh Resolution EEG

    High Resolution EEG

    Also known as: electrical source imaging

  • DeviceStereo-electroencephalography

    SEEG

    Also known as: depth-electroencephalography

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of electrical source localization of inter-ictal and ictal discharges using high-Resolution EEG for localizing the epileptogenic zone (the stereo-electroencephalography will be the reference method)

    results of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG

    Time frame: 3 years

Secondary outcomes

  1. inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.

    sources localization of inter-ictal and ictal discharges will be interpreted by two independant epileptologists, blinded to the results of stereo-EEG.

    Time frame: 3 years

  2. sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision

    decision of surgery and the limits of the cortectomy established with electrical source imaging will be compared to the decision of surgery and the limits of the cortectomy established with Stereo-electroencephalography.

    Time frame: 3 years

07

Study locations

2 sites
  • University Hospital of Marseille
    Marseille, 13000, France
  • Central Hospital
    Nancy, 54000, France
08

References and documents

Publications

  • Maillard L, Koessler L, Colnat-Coulbois S, Vignal JP, Louis-Dorr V, Marie PY, Vespignani H. Combined SEEG and source localisation study of temporal lobe schizencephaly and polymicrogyria. Clin Neurophysiol. 2009 Sep;120(9):1628-36. doi: 10.1016/j.clinph.2009.06.022. Epub 2009 Jul 24. PubMed 19632148 ↗
  • Koessler L, Benar C, Maillard L, Badier JM, Vignal JP, Bartolomei F, Chauvel P, Gavaret M. Source localization of ictal epileptic activity investigated by high resolution EEG and validated by SEEG. Neuroimage. 2010 Jun;51(2):642-53. doi: 10.1016/j.neuroimage.2010.02.067. Epub 2010 Mar 4. PubMed 20206700 ↗
  • Koessler L, Cecchin T, Caspary O, Benhadid A, Vespignani H, Maillard L. EEG-MRI co-registration and sensor labeling using a 3D laser scanner. Ann Biomed Eng. 2011 Mar;39(3):983-95. doi: 10.1007/s10439-010-0230-0. Epub 2010 Dec 8. PubMed 21140291 ↗
  • Koessler L, Salido-Ruiz R, Ranta R, Louis-Dorr V, Gavaret M, Maillard L. Influence of source separation and montage on ictal source localization. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2898-901. doi: 10.1109/IEMBS.2010.5626321. PubMed 21095980 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01090934
Lead sponsor
Central Hospital, Nancy, France
Collaborators
University Hospital, Marseille, CHU de Reims, Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
louis maillard (Dr Louis MAILLARD, Central Hospital, Nancy, France) — Principal investigator
First posted
Mar 23, 2010
Start date
Oct 2009
Primary completion
Oct 2013
Completion
Nov 2013
Last update
Jan 27, 2016

Study contacts

Louis Maillard, MD, PhD
principal investigator · Central Hospital, Nancy, France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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