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CompletedNCT02898935ELEC3DUpdated Sep 18, 2018

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

An observational study in Focal Epilepsy, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Months to 17 Years. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Months to 17 Years
Sex
All
01

Study 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.

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Conditions studied

  • Focal Epilepsy
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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 30 is below the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • contraindication to anesthesia or surgery
  • refusal (of parents or child) to participate in the study
  • no health insurance coverage
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
30 participants (actual)
Patient registry
No
06

What researchers measure

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

    Time frame: 1 day

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Study locations

1 site
  • Fondation Ophtalmologique A. de Rothschild
    Paris, 75019, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02898935
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Sep 13, 2016
Start date
Nov 25, 2016
Primary completion
May 2018
Completion
Jul 2018
Last update
Sep 18, 2018

Study contacts

Mathilde CHIPAUX, MD
principal investigator · Fondation OPH A de Rothschild
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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