Improving EPilepsy Surgery Management and progNOsis Using Virtual Epileptic Patient Software (VEP) (EPINOV)
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgical strategy based on a software
Sponsored by
About this trial
This is an interventional other trial for Epilepsy
Eligibility Criteria
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.
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group with Virtual Epileptic Patient brain access data
Group without Virtual Epileptic Patient brain access data
Arm Description
Outcomes
Primary Outcome Measures
Clinical success, defined as seizure free patient without disabling side effect (clinical judgment) at 12-month follow-up
Number of seizure (Engel I)
Secondary Outcome Measures
Full Information
NCT ID
NCT03643016
First Posted
August 21, 2018
Last Updated
November 4, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03643016
Brief Title
Improving EPilepsy Surgery Management and progNOsis Using Virtual Epileptic Patient Software (VEP)
Acronym
EPINOV
Official Title
Improving EPilepsy Surgery Management and progNOsis Using Virtual Epileptic Patient Software (VEP)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
December 23, 2024 (Anticipated)
Study Completion Date
December 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
356 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group with Virtual Epileptic Patient brain access data
Arm Type
Experimental
Arm Title
Group without Virtual Epileptic Patient brain access data
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Surgical strategy based on a software
Intervention Description
Surgical strategy décision based on a software
Primary Outcome Measure Information:
Title
Clinical success, defined as seizure free patient without disabling side effect (clinical judgment) at 12-month follow-up
Description
Number of seizure (Engel I)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Bartolomei, MD/PhD
Phone
+33491385829
Email
fabrice.bartolomei@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Garrido-Pradalié
Organizational Affiliation
Assitance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving EPilepsy Surgery Management and progNOsis Using Virtual Epileptic Patient Software (VEP)
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