Clinical Trials Directory

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

TypeNameDescription
OTHERSurgical strategy based on a softwareSurgical 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.