Multimodal Imaging in Pre-surgical Evaluation of Epilepsy (EPIMAGE)

Contribution of Multimodal Imaging (MRI, PET, MEG) in Pre-surgical Evaluation of Drug-resistant Focal Epilepsy

Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal. Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily due to seizure-related fatalities, in comparison with the general population. The only therapeutic option for this form of epilepsy is the surgical removal of the region of the brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise localization of the EZ based on a comprehensive pre-surgical evaluation of patients.

Today the gold standard for localizing the EZ and validating a non-invasive technique for localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose) and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the pre-surgical localization of the EZ has already been shown, no wide-scale study has examined the cumulative contribution of these three techniques.

Study Overview

• Status: Unknown
• Conditions: Partial Epilepsy

Detailed Description

The purpose of this study is (i) to evaluate rigorously the diagnostic value of multimodal imaging for non-invasive localization of the EZ and (ii) to better target the indications for intracerebral recordings (SEEG).

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Julien Jung, Dr.; Phone Number: 0033 472 117 833; Email: julien.jung@chu-lyon.fr

Study Locations

• France
  • Lyon, France
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Julien JUNG, Dr; Phone Number: 0033 472 117 833

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 patients with drug-resistant focal epilepsy and candidates for epilepsy surgery will be recruited.

Description

Inclusion Criteria:

• Patient with drug-resistant focal epilepsy
• Candidates for pre-surgical evaluation including FDG PET, MRI, MEG and SEEG recordings.
• Age 18-65 years
• EEG-confirmed focal epilepsy for >2 years
• Signed informed consent form.

Exclusion Criteria:

• Age <18 years and >65 years
• Contraindication to the MRI
• Pregnant woman
• Head size incompatible with MEG recordings
• Adult subject to legal protection measure.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localizing value of MEG, FDG-PET and MRI for the determination of the Epileptogenic Zone defined by SEEG recordings	Pathological volumes defined by multimodal imaging (MEG, FDG-PET and MRI) will be compared to the topography of the EZ defined by SEEG recordings. For each patient, we will sum the total number of intracerebral depth electrodes included in the EZ. Then, for each functional volume obtained from multimodal data fusion, we will count the total number of electrodes in the latter (Vol elec_tot) and the number of electrodes included in the EZ (Vol elec_ze).	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity and specificity	For each functional volume, two parameters will be defined: sensitivity and specificity. These parameters will be calculated as follows: sensitivity = (Vol elec_ze) / (Pat elec_ze) and specificity = (Vol elec_ze) / (Vol elec_tot).	180 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: François MAUGUIERE, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: November 22, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Estimate): November 30, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: multimodal imaging; SEEG; focal epilepsy; pre-surgical evaluation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: 2011-703