search
Back to results

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

Primary Purpose

Partial Epilepsy

Status
Unknown status
Phase
Locations
France
Study Type
Observational
Intervention
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Partial Epilepsy focused on measuring focal epilepsy, pre-surgical evaluation, multimodal imaging, SEEG

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospices Civils de LyonRecruiting

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
October 22, 2012
Last Updated
November 29, 2012
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT01735032
Brief Title
Multimodal Imaging in Pre-surgical Evaluation of Epilepsy
Acronym
EPIMAGE
Official Title
Contribution of Multimodal Imaging (MRI, PET, MEG) in Pre-surgical Evaluation of Drug-resistant Focal Epilepsy
Study Type
Observational

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy
Keywords
focal epilepsy, pre-surgical evaluation, multimodal imaging, SEEG

7. Study Design

Enrollment
140 (Anticipated)
Primary Outcome Measure Information:
Title
Localizing value of MEG, FDG-PET and MRI for the determination of the Epileptogenic Zone defined by SEEG recordings
Description
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).
Time Frame
180 days
Secondary Outcome Measure Information:
Title
sensitivity and specificity
Description
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).
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Study Population Description
100 patients with drug-resistant focal epilepsy and candidates for epilepsy surgery will be recruited.
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Jung, Dr.
Phone
0033 472 117 833
Email
julien.jung@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François MAUGUIERE
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien JUNG, Dr
Phone
0033 472 117 833

12. IPD Sharing Statement

Learn more about this trial

Multimodal Imaging in Pre-surgical Evaluation of Epilepsy

We'll reach out to this number within 24 hrs