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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03643016
Acronym
EPINOV
Enrollment
356
Registered
2018-08-22
Start date
2019-06-26
Completion date
2025-12-23
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Brief 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

Interventions

OTHERSurgical strategy based on a software

Surgical strategy décision based on a software

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical success, defined as seizure free patient without disabling side effect (clinical judgment) at 12-month follow-up12 monthsNumber of seizure (Engel I)

Countries

France

Contacts

Primary ContactFabrice Bartolomei, MD/PhD
fabrice.bartolomei@ap-hm.fr+33491385829

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026