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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Enrolling

Conditions

Epilepsy

Treatments

Other: Surgical strategy based on a software

Study type

Interventional

Funder types

Other

Identifiers

NCT03643016
2018-41

Details and patient eligibility

About

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

Enrollment

356 estimated patients

Sex

All

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

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 term SEEG-monitoring.

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

356 participants in 2 patient groups

Group with Virtual Epileptic Patient brain access data
Experimental group
Treatment:
Other: Surgical strategy based on a software
Group without Virtual Epileptic Patient brain access data
No Intervention group

Trial contacts and locations

1

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Central trial contact

Fabrice Bartolomei, MD/PhD

Data sourced from clinicaltrials.gov

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