National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug

Study Overview
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Brief Summary
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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.

Official Title
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National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug

Conditions
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Epilepsy Intractable, Focal Epilepsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 8 years old intractable focal epilepsy presurgical evaluation or phase 1 planified with focal EEG activity : more than 3 EEG interictal epileptic events per hour patient and/or legal representant given their written consent for their participation in the study Exclusion Criteria: MRI contraindication pregnancy uncomfortable prolonged lying position frequent primary or secondary generalised seizure with tonic clonic movements (>2 per week) previous epilepsy surgery important mental retardation

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with EEG-fMRI data<br>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. | |
| without EEG-fMRI data<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who finally underwent a surgery after EEG-fMRI results even if they were considered as non surgical after standard presurgical evaluation |  | 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. | 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 | 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) |  | 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 | 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG-fMRI, brain imaging, presurgical evaluation, epilepsy surgery