Multimodal Imaging in Pre-surgical Evaluation of Epilepsy (EPIMAGE)
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|ClinicalTrials.gov Identifier: NCT01735032|
Recruitment Status : Unknown
Verified October 2012 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : November 28, 2012
Last Update Posted : November 30, 2012
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Contribution of Multimodal Imaging (MRI, PET, MEG) in Pre-surgical Evaluation of Drug-resistant Focal Epilepsy|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||May 2016|
- Localizing value of MEG, FDG-PET and MRI for the determination of the Epileptogenic Zone defined by SEEG recordings [ Time Frame: 180 days ]
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).
- sensitivity and specificity [ Time Frame: 180 days ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735032
|Contact: Julien Jung, Dr.||0033 472 117 email@example.com|
|Hospices Civils de Lyon||Recruiting|
|Contact: Julien JUNG, Dr 0033 472 117 833|
|Principal Investigator:||François MAUGUIERE||Hospices Civils de Lyon|