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

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.

Study Overview

• Status: Completed
• Conditions: Focal Epilepsy; Epilepsy Intractable

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHRU de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients followed for a focal intractable epilepsy and engaged in a pre surgical evaluation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
with EEG-fMRI data; 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; 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?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Louise Tyvaert, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2011
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: brain imaging; epilepsy surgery; EEG-fMRI; presurgical evaluation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: 2009_54/1021; 2010-A01101-38 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO