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OpenTrials
Completed

NCT Number: NCT02898935

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

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.

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Key information

Age range

18 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. number of patients for whom surgical strategy would change if using the software

    Time frame: 1 day

    change in medical strategy includes surgery indication, resection volume, topography of resection area

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: ELEC3D

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2016
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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