Trials / Unknown
UnknownNCT03643016
Improving EPilepsy Surgery Management and progNOsis Using Virtual Epileptic Patient Software (VEP)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 356 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Academic / Other
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Surgical strategy based on a software | Surgical strategy décision based on a software |
Timeline
- Start date
- 2019-06-26
- Primary completion
- 2024-12-23
- Completion
- 2025-12-23
- First posted
- 2018-08-22
- Last updated
- 2022-11-07
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03643016. Inclusion in this directory is not an endorsement.