<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/NCT02245061</url>
  </required_header>
  <id_info>
    <org_study_id>2014.865</org_study_id>
    <secondary_id>2014-A00495-42</secondary_id>
    <nct_id>NCT02245061</nct_id>
  </id_info>
  <brief_title>Cortical Excitability Assessment Using Paired Pulses</brief_title>
  <acronym>PP</acronym>
  <official_title>Cortical Excitability Assessment of Pharmacoresistant Focal Epilepsy Using Direct Electrical Stimulation During Stereo-electroencephalography</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>
      The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy&#xD;
      presurgical assessment frequently requires intracranial recordings like&#xD;
      stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is&#xD;
      commonly used during SEEG for functional mapping or to induce seizure.&#xD;
&#xD;
      However, the recording of seizures is sometimes insufficient to circumscribe the EZ and&#xD;
      development of new biomarkers is necessary.&#xD;
&#xD;
      The cortex within the EZ is thought to be hyperexcitable. The &quot;paired pulses&quot; paradigm, using&#xD;
      transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical&#xD;
      excitability level. The investigators hypothesize that paired pulses DES during SEEG could&#xD;
      provide useful information for EZ identification.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 9, 2014</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex</measure>
    <time_frame>between Day 7 and 21 (End of the stereoelectroencephalographic recordings)</time_frame>
    <description>Low frequency single pulse electrical stimulation induces several cortico-cortical electroencephalographic responses: early-physiological and/or late-pathological. We expect different paired pulses modulation of those responses according the excitability level of the stimulated cortex (in terms of latency, amplitude, surface, frequency power)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of a difference of responses patterns between anatomic regions and/or lesion type</measure>
    <time_frame>between Day 7 and 21 (End of the stereoelectroencephalographic recordings )</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations</measure>
    <time_frame>Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Focal Epilepsy</condition>
  <arm_group>
    <arm_group_label>paired pulses cortical electrical stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>paired pulses cortical electrical stimulation</intervention_name>
    <arm_group_label>paired pulses cortical electrical stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18 years old&#xD;
&#xD;
          -  Pharmacoresistant focal epilepsy patients undergoing a stereo-electroencephalographic&#xD;
             recording&#xD;
&#xD;
          -  Provide written consent to the study after receiving clear information&#xD;
&#xD;
          -  Be a beneficiary or member of health insurance plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient with contraindication for MRI scanning&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prohibition on participation in other research, apart from any other&#xD;
             non-interventional research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sylvain RHEIMS, MD</last_name>
    <phone>4 17 30 60 64</phone>
    <phone_ext>+33</phone_ext>
    <email>sylvain.rheims@univ-lyon1.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital neurologique de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvain RHEIMS, MD</last_name>
      <phone>4 17 30 60 64</phone>
      <phone_ext>+33</phone_ext>
      <email>sylvain.rheims@chu-lyon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>October 22, 2019</last_update_submitted>
  <last_update_submitted_qc>October 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacoresistant focal epilepsy</keyword>
  <keyword>cortical excitability</keyword>
  <keyword>paired pulses</keyword>
  <keyword>TMS</keyword>
  <keyword>SEEG</keyword>
  <keyword>DES</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/NCT02245061
org study id: 2014.865
secondary id: 2014-A00495-42
nct id: NCT02245061
lead sponsor: 
has dmc: No
The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy
      presurgical assessment frequently requires intracranial recordings like
      stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is
      commonly used during SEEG for functional mapping or to induce seizure.

      However, the recording of seizures is sometimes insufficient to circumscribe the EZ and
      development of new biomarkers is necessary.

      The cortex within the EZ is thought to be hyperexcitable. The "paired pulses" paradigm, using
      transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical
      excitability level. The investigators hypothesize that paired pulses DES during SEEG could
      provide useful information for EZ identification.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Presence of a significant difference between the evoked responses to paired pulses cortical electrical stimulation of epileptogenic zone cortex and of normal cortex
time frame: between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
description: Low frequency single pulse electrical stimulation induces several cortico-cortical electroencephalographic responses: early-physiological and/or late-pathological. We expect different paired pulses modulation of those responses according the excitability level of the stimulated cortex (in terms of latency, amplitude, surface, frequency power)
measure: Presence of a difference of responses patterns between anatomic regions and/or lesion type
time frame: between Day 7 and 21 (End of the stereoelectroencephalographic recordings )
measure: Presence of a difference between transcranial magnetic paired pulses stimulations and intracranial paired pulses cortical direct electrical stimulations
time frame: Between Day 7 and 21 (End of the stereoelectroencephalographic recordings)
arm group label: paired pulses cortical electrical stimulation
arm group type: Experimental
intervention type: Other
intervention name: paired pulses cortical electrical stimulation
arm group label: paired pulses cortical electrical stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sylvain RHEIMS, MD
phone: 4 17 30 60 64
phone ext: +33
email: sylvain.rheims@univ-lyon1.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Epilepsies, Partial