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

NCT03643016 | Unknown

• 1 other identifier: 2018-41
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Clinical success, defined as seizure free patient without disabling side effect (clinical judgment) at 12-month follow-up

  Number of seizure (Engel I)

  12 months

Study Arms (2)

Group with Virtual Epileptic Patient brain access data

EXPERIMENTAL

Other: Surgical strategy based on a software

Group without Virtual Epileptic Patient brain access data

NO INTERVENTION

Interventions

Surgical strategy based on a software OTHER

Surgical strategy décision based on a software

Group with Virtual Epileptic Patient brain access data

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Emilie Garrido-Pradalié

  Assitance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Fabrice Bartolomei, MD/PhD

CONTACT

+33491385829; fabrice.bartolomei@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: June 26, 2019
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2025
• Last Updated: November 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)