<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/NCT03278210</url>
  </required_header>
  <id_info>
    <org_study_id>2009_54/1021</org_study_id>
    <secondary_id>2010-A01101-38</secondary_id>
    <nct_id>NCT03278210</nct_id>
  </id_info>
  <brief_title>National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug</brief_title>
  <acronym>ENERGY</acronym>
  <official_title>National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main goal of this study is to evaluate the additional value of EEG-fMRI method in the&#xD;
      presurgical evaluation of focal intractable epilepsy.&#xD;
&#xD;
      To consider a patient for surgery, the main difficulty is to define accurately the&#xD;
      epileptogenic zone. This definition is complex and is often supported by several types of&#xD;
      exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will&#xD;
      evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic&#xD;
      zone definition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 13, 2011</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>A score between 1-4 reflects an improvement in epilepsy and between 5-6 a lack of improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who finally underwent a surgery after EEG-fMRI results even if they were considered as non surgical after standard presurgical evaluation</measure>
    <time_frame>1 year after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>The percentage of non-localizing or lateralizing data (score 4 on the evaluation grid) will be calculated in relation to the total number of acquired victual data and compared with the equivalent percentage corresponding to the inter-state data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life score (QOLIE 31)</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Comparison of the evolution of quality of life indices to 1 year of epilepsy surgery between the two groups using French versions of QOLIE 31 scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who finally underwent a surgery after EEG-fMRI results on SEEG implantation strategy after standard presurgical evaluation(concluded to a surgical management or an SEEG)</measure>
    <time_frame>1 year after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distinction of patients according to the type of their epilepsy: temporal / extra temporal.</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>measure of the &quot;type of epilepsy&quot; effect on all the parameters studied re-evaluation of the points taking into account this distinction: main criterion, secondary criteria</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">290</enrollment>
  <condition>Epilepsy Intractable</condition>
  <condition>Focal Epilepsy</condition>
  <arm_group>
    <arm_group_label>with EEG-fMRI data</arm_group_label>
    <description>EEG-fMRI was performed during the pre surgical evaluation, and its results were provided to the clinicians before surgery planification. The final surgery strategy was decided with EEG-fMRI results.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without EEG-fMRI data</arm_group_label>
    <description>EEG-fMRI was performed during the pre surgical evaluation, but clinicians were blinded to the results. The final surgery strategy was decided without EEG-fMRI results.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients followed for a focal intractable epilepsy and engaged in a pre surgical&#xD;
        evaluation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 8 years old&#xD;
&#xD;
          -  intractable focal epilepsy&#xD;
&#xD;
          -  presurgical evaluation or &quot;phase 1&quot; planified&#xD;
&#xD;
          -  with focal EEG activity : more than 3 EEG interictal epileptic events per hour&#xD;
&#xD;
          -  patient and/or legal representant given their written consent for their participation&#xD;
             in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MRI contraindication&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  uncomfortable prolonged lying position&#xD;
&#xD;
          -  frequent primary or secondary generalised seizure with tonic clonic movements (&gt;2 per&#xD;
             week)&#xD;
&#xD;
          -  previous epilepsy surgery&#xD;
&#xD;
          -  important mental retardation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Louise Tyvaert, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Louise Tyvaert, MD,PhD</last_name>
    <email>l.tyvaert@chru-nancy.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Roger Salengro, CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Philippe Derambure, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>June 25, 2019</last_update_submitted>
  <last_update_submitted_qc>June 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EEG-fMRI</keyword>
  <keyword>brain imaging</keyword>
  <keyword>presurgical evaluation</keyword>
  <keyword>epilepsy surgery</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>
    <mesh_term>Drug Resistant Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03278210
org study id: 2009_54/1021
secondary id: 2010-A01101-38
nct id: NCT03278210
lead sponsor: 
has dmc: No
The main goal of this study is to evaluate the additional value of EEG-fMRI method in the
      presurgical evaluation of focal intractable epilepsy.

      To consider a patient for surgery, the main difficulty is to define accurately the
      epileptogenic zone. This definition is complex and is often supported by several types of
      exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will
      evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic
      zone definition.
observational model: Case-Control
time perspective: Prospective
measure: Efficacity of surgery measured by the International League Against Epilepsy (ILAE) scale
time frame: 1 year after surgery
description: A score between 1-4 reflects an improvement in epilepsy and between 5-6 a lack of improvement.
measure: Number of patients who finally underwent a surgery after EEG-fMRI results even if they were considered as non surgical after standard presurgical evaluation
time frame: 1 year after surgery
measure: Percentage of inter-ictal and ictal discharges for localizing the epileptogenic zone by EEG
time frame: 1 year after surgery
description: The percentage of non-localizing or lateralizing data (score 4 on the evaluation grid) will be calculated in relation to the total number of acquired victual data and compared with the equivalent percentage corresponding to the inter-state data.
measure: Quality of life score (QOLIE 31)
time frame: 1 year after surgery
description: Comparison of the evolution of quality of life indices to 1 year of epilepsy surgery between the two groups using French versions of QOLIE 31 scales
measure: Number of patients who finally underwent a surgery after EEG-fMRI results on SEEG implantation strategy after standard presurgical evaluation(concluded to a surgical management or an SEEG)
time frame: 1 year after surgery
measure: Distinction of patients according to the type of their epilepsy: temporal / extra temporal.
time frame: 1 year after surgery
description: measure of the "type of epilepsy" effect on all the parameters studied re-evaluation of the points taking into account this distinction: main criterion, secondary criteria
arm group label: with EEG-fMRI data
description: EEG-fMRI was performed during the pre surgical evaluation, and its results were provided to the clinicians before surgery planification. The final surgery strategy was decided with EEG-fMRI results.
arm group label: without EEG-fMRI data
description: EEG-fMRI was performed during the pre surgical evaluation, but clinicians were blinded to the results. The final surgery strategy was decided without EEG-fMRI results.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Louise Tyvaert, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Louise Tyvaert, MD,PhD
email: l.tyvaert@chru-nancy.fr
facility: 
status: Recruiting
investigator: 
country: France
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Epilepsies, Partial
mesh term: Drug Resistant Epilepsy
sharing ipd: No