Improving EPilepsy Surgery Management and progNOsis Using Virtual Epileptic Patient Software (VEP)

Last updated: November 4, 2022
Sponsor: Assistance Publique Hopitaux De Marseille
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT03643016
2018-41
  • Ages 12-65
  • All Genders

Study Summary

Every year, thousands of patients worldwide with drug resistant focal epilepsy (DRE) undergo resective brain surgery with the aim of achieving seizure freedom.

Despite technical advances over the last 50 years, the success rate of epilepsy surgery in terms of seizure freedom has not greatly improved, remaining overall at around 50%. Depending on features of individual cases, presurgical evaluation includes a first phase of non-invasive data including video-EEG recordings, magnetoencephalography, structural and functional neuroimaging and neuropsychological evaluation. If these investigations do not allow adequate localization of likely region of seizure organization in the brain (the epileptogenic zone, EZ), then a second invasive phase using intracerebral EEG recording may be necessary (stereoelectroencephalography, SEEG). Interpretation of SEEG remains difficult in many cases, in particular since seizure onset is often characterized by discharges that very rapidly involve several distinct brain regions.

No reliable measuring instrument currently exists to combine the various prognostic factors for a given patient. This leads to great uncertainty on an individual scale in predicting the effects of surgery. The mapping of epileptic networks in patients with DRE is an innovative scientifically-validated and clinically-tested method to significantly improve accuracy of SEEG and presurgical interpretation and guide surgical strategies in patients with DRE. Therefore, the investigators developed the Virtual Epilepsy Patient software. Retrospective study already demonstrated the pertinence of this approach in improving the anatomical mapping of epileptogenic networks. Now, the investigators aim to prospectively demonstrate the role of VEP during presurgical evaluation of DRE patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient or pediatric patient suffering from drug-resistant focal epilepsy.
  • Standardized presurgical evaluation including medical history, scalp video-EEG, 3T MRI (DTI and rsMRI), FDG-PET, Neuropsychological tests.
  • Inpatient in one of the participating centers for recording seizure during long termSEEG-monitoring.

Exclusion

Exclusion Criteria:

  • Epilepsy surgery performed without the requirement of SEEG or contra-indication toepilepsy surgery.

Study Design

Total Participants: 356
Study Start date:
June 26, 2019
Estimated Completion Date:
December 23, 2025

Connect with a study center

  • Hospices Civils de Lyon

    Lyon,
    France

    Site Not Available

  • Assistance Publique Hopitaux de Marseille

    Marseille, 13354
    France

    Active - Recruiting

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