Improvement of the Accuracy of Spatial Representation of Invasive Exploratory Electrodes in Focal Epilepsy (ELEC3D)

Reconstruction software allows visualization of cortical structure in 3 dimensions, showing on a single picture the position of all the electrodes. The EEG signal of each recording plot of the electrode is analyzed and compared with the underlying brain structure reconstructed by the software. It is therefore possible to visualize 1) ictogenic and epileptogenic areas using neurophysiological stereoelectroencephalography (SEEG) data and 2) adjacent functional cortical areas with functional imaging and SEEG. Software makes it possible to determine the links between these areas. This study aims to show that using these software is an asset in surgical decision and in the choice of surgical strategy.

Each patient has presurgical evaluation (usual care), including morphologic and (if necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist. The surgical decision will be taken according to the usual staff procedures, based on the usual examination results. After the decision making process, the staff will be asked to reconsider the surgical decision, according to the analysis provided by the software. The discrepancies between the decisions will be recorded.

Study Overview

• Status: Completed
• Conditions: Focal Epilepsy

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtalmologique A. De Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with drug resistant focal epilepsy, potential candidates for surgery, scheduled for deep brain electrodes exploration.

Description

Inclusion Criteria:

• children aged 18 months to 17 years old
• drug resistant focal epilepsy
• scheduled for deep brain electrodes exploration to assess surgical indication

Exclusion Criteria:

• contraindication to anesthesia or surgery
• refusal (of parents or child) to participate in the study
• no health insurance coverage

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients for whom surgical strategy would change if using the software	change in medical strategy includes surgery indication, resection volume, topography of resection area	1 day

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Mathilde CHIPAUX, MD, Fondation OPH A de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: MCX_2015_32