Clinical Trials Directory

Trials / Completed

CompletedNCT02898935

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

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
18 Months – 17 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2016-11-25
Primary completion
2018-05-01
Completion
2018-07-01
First posted
2016-09-13
Last updated
2018-09-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02898935. Inclusion in this directory is not an endorsement.