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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease
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
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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01735032

Contact: Julien Jung, Dr. 0033 472 117 833

Hospices Civils de Lyon Recruiting
Lyon, France
Contact: Julien JUNG, Dr    0033 472 117 833      
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: François MAUGUIERE Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon Identifier: NCT01735032     History of Changes
Other Study ID Numbers: 2011-703
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: October 2012

Keywords provided by Hospices Civils de Lyon:
focal epilepsy
pre-surgical evaluation
multimodal imaging

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases