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

• Conditions: Focal Epilepsy; Epilepsy Intractable

• Registration Number: NCT03278210
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-13
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-26
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale	1 year after surgery	A score between 1-4 reflects an improvement in epilepsy and between 5-6 a lack of improvement.

Secondary Outcome Measures

Name	Time	Method
Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG	1 year after surgery	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.
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
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
Quality of life score (QOLIE 31)	1 year after surgery	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
Distinction of patients according to the type of their epilepsy: temporal / extra temporal.	1 year after surgery	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

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHRU de Lille; 🇫🇷 Lille, France