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

Focal Epilepsy Clinical Trial

— ELEC3D  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898935
• Other study ID #: MCX_2015_32
• Status: Completed
• Start date: November 25, 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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