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

NCT ID: NCT02898935

Last Updated: 2018-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-25

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Focal Epilepsy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathilde CHIPAUX, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation OPH A de Rothschild

Locations

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Fondation Ophtalmologique A. de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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MCX_2015_32

Identifier Type: -

Identifier Source: org_study_id

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