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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01735032
First received: October 22, 2012
Last updated: November 29, 2012
Last verified: October 2012
  Purpose

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
Partial Epilepsy

Study Type: Observational
Official Title: Contribution of Multimodal Imaging (MRI, PET, MEG) in Pre-surgical Evaluation of Drug-resistant Focal Epilepsy

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Localizing value of MEG, FDG-PET and MRI for the determination of the Epileptogenic Zone defined by SEEG recordings [ Time Frame: 180 days ] [ Designated as safety issue: No ]

    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:
  • sensitivity and specificity [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 140
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735032

Contacts
Contact: Julien Jung, Dr. 0033 472 117 833 julien.jung@chu-lyon.fr

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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01735032     History of Changes
Other Study ID Numbers: 2011-703
Study First Received: October 22, 2012
Last Updated: November 29, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on August 28, 2014