An observational study in Epilepsy Intractable and Focal Epilepsy, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by University Hospital, Lille · Observational
The main goal of this study is to evaluate the additional value of EEG-fMRI method in the presurgical evaluation of focal intractable epilepsy.
To consider a patient for surgery, the main difficulty is to define accurately the epileptogenic zone. This definition is complex and is often supported by several types of exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic zone definition.
Patients followed for a focal intractable epilepsy and engaged in a pre surgical evaluation.
Exclusion Criteria:
EEG-fMRI was performed during the pre surgical evaluation, and its results were provided to the clinicians before surgery planification. The final surgery strategy was decided with EEG-fMRI results.
EEG-fMRI was performed during the pre surgical evaluation, but clinicians were blinded to the results. The final surgery strategy was decided without EEG-fMRI results.
Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale
A score between 1-4 reflects an improvement in epilepsy and between 5-6 a lack of improvement.
Time frame: 1 year after surgery
Number of patients who finally underwent a surgery after EEG-fMRI results even if they were considered as non surgical after standard presurgical evaluation
Time frame: 1 year after surgery
Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG
The percentage of non-localizing or lateralizing data (score 4 on the evaluation grid) will be calculated in relation to the total number of acquired victual data and compared with the equivalent percentage corresponding to the inter-state data.
Time frame: 1 year after surgery
Quality of life score (QOLIE 31)
Comparison of the evolution of quality of life indices to 1 year of epilepsy surgery between the two groups using French versions of QOLIE 31 scales
Time frame: 1 year after surgery
Number of patients who finally underwent a surgery after EEG-fMRI results on SEEG implantation strategy after standard presurgical evaluation(concluded to a surgical management or an SEEG)
Time frame: 1 year after surgery
Distinction of patients according to the type of their epilepsy: temporal / extra temporal.
measure of the "type of epilepsy" effect on all the parameters studied re-evaluation of the points taking into account this distinction: main criterion, secondary criteria
Time frame: 1 year after surgery
Plan to share: No
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University Hospital, Lille