<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01735032</url>
  </required_header>
  <id_info>
    <org_study_id>2011-703</org_study_id>
    <nct_id>NCT01735032</nct_id>
  </id_info>
  <brief_title>Multimodal Imaging in Pre-surgical Evaluation of Epilepsy</brief_title>
  <acronym>EPIMAGE</acronym>
  <official_title>Contribution of Multimodal Imaging (MRI, PET, MEG) in Pre-surgical Evaluation of Drug-resistant Focal Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Epilepsy is the most common chronic neurological disorder in the world, affecting more than&#xD;
      50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to&#xD;
      all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal.&#xD;
      Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily&#xD;
      due to seizure-related fatalities, in comparison with the general population. The only&#xD;
      therapeutic option for this form of epilepsy is the surgical removal of the region of the&#xD;
      brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise&#xD;
      localization of the EZ based on a comprehensive pre-surgical evaluation of patients.&#xD;
&#xD;
      Today the gold standard for localizing the EZ and validating a non-invasive technique for&#xD;
      localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or&#xD;
      SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral&#xD;
      depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic&#xD;
      Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose)&#xD;
      and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the&#xD;
      pre-surgical localization of the EZ has already been shown, no wide-scale study has examined&#xD;
      the cumulative contribution of these three techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is (i) to evaluate rigorously the diagnostic value of multimodal&#xD;
      imaging for non-invasive localization of the EZ and (ii) to better target the indications for&#xD;
      intracerebral recordings (SEEG).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Localizing value of MEG, FDG-PET and MRI for the determination of the Epileptogenic Zone defined by SEEG recordings</measure>
    <time_frame>180 days</time_frame>
    <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.&#xD;
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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sensitivity and specificity</measure>
    <time_frame>180 days</time_frame>
    <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).</description>
  </secondary_outcome>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Partial Epilepsy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        100 patients with drug-resistant focal epilepsy and candidates for epilepsy surgery will be&#xD;
        recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with drug-resistant focal epilepsy&#xD;
&#xD;
          -  Candidates for pre-surgical evaluation including FDG PET, MRI, MEG and SEEG&#xD;
             recordings.&#xD;
&#xD;
          -  Age 18-65 years&#xD;
&#xD;
          -  EEG-confirmed focal epilepsy for &gt;2 years&#xD;
&#xD;
          -  Signed informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years and &gt;65 years&#xD;
&#xD;
          -  Contraindication to the MRI&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Head size incompatible with MEG recordings&#xD;
&#xD;
          -  Adult subject to legal protection measure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>François MAUGUIERE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julien Jung, Dr.</last_name>
    <phone>0033 472 117 833</phone>
    <email>julien.jung@chu-lyon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julien JUNG, Dr</last_name>
      <phone>0033 472 117 833</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 29, 2012</last_update_submitted>
  <last_update_submitted_qc>November 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>focal epilepsy</keyword>
  <keyword>pre-surgical evaluation</keyword>
  <keyword>multimodal imaging</keyword>
  <keyword>SEEG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Epilepsies, Partial</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01735032
org study id: 2011-703
nct id: NCT01735032
lead sponsor: 
has dmc: No
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.
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).
measure: Localizing value of MEG, FDG-PET and MRI for the determination of the Epileptogenic Zone defined by SEEG recordings
time frame: 180 days
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).
measure: sensitivity and specificity
time frame: 180 days
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).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: François MAUGUIERE
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: Julien Jung, Dr.
phone: 0033 472 117 833
email: julien.jung@chu-lyon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Epilepsies, Partial