Clinical trial NCT01735032: Multimodal Imaging in Pre-surgical Evaluation of Epilepsy
Official title: Contribution of Multimodal Imaging (MRI, PET, MEG) in Pre-surgical Evaluation of Drug-resistant Focal Epilepsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Partial Epilepsy
Keywords: focal epilepsy
pre-surgical evaluation
multimodal imaging
SEEG
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients with drug-resistant focal epilepsy and candidates for epilepsy surgery will be recruited.

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Localizing value of MEG, FDG-PET and MRI for the determination of the Epileptogenic Zone defined by SEEG recordings
timeFrame: 180 days
Secondary outcomes:
measure: sensitivity and specificity
timeFrame: 180 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: François MAUGUIERE
role: PRINCIPAL_INVESTIGATOR
References: