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

NCT02898935 | Completed

• 1 other identifier: MCX_2015_32
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mathilde CHIPAUX, MD

  Fondation OPH A de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: November 25, 2016
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-01

Locations

FR (1)