<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/NCT04451278</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01561-38</org_study_id>
    <nct_id>NCT04451278</nct_id>
  </id_info>
  <brief_title>RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy</brief_title>
  <acronym>RESPIRE</acronym>
  <official_title>RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting&#xD;
      networks. It allows, without active participation of the patients, to identify and analyze&#xD;
      the different functional brain networks. The analysis of r-fMRI can be done thanks to the&#xD;
      graph theory, which is based on the based on the calculation of quantifiable parameters&#xD;
      applied to the functional network studied, making it possible to assess its effectiveness.&#xD;
&#xD;
      To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data&#xD;
      in order to obtain parameters useful for the useful parameters for the individual prognosis&#xD;
      of children who have to be operation for drug-resistant lesional epilepsy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 30, 2020</start_date>
  <completion_date type="Anticipated">April 2026</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy.</measure>
    <time_frame>One year</time_frame>
    <description>The variables measured with functional MRI will correspond to topological parameters of functional connectivity measured locally at the level of the lesion: the degree, the clustering coefficient and path length. Surgical success will be evaluated by a score of 1 on the modified Engel classification at one year after surgery.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Resting-state functional MRI (r-fMRI)</arm_group_label>
    <description>The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional fMRI-r sequence, called resting state, and performed before injection of gadoline contrast.&#xD;
A neuropsychological evaluation is performed as part of the 6 months prior to the procedure. These data will be used as a basis for the evaluation of language visual and language recovery.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from 6 to 18 years old receiving an MRI as part of a preoperative assessment of&#xD;
        lesion epilepsy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged between 6 and 18 years&#xD;
&#xD;
          -  Receiving an MRI for lesional drug-resistant epilepsy&#xD;
&#xD;
          -  Affiliated or beneficiary of a social security plan&#xD;
&#xD;
          -  Whose parents or guardians have received information about the study and have given&#xD;
             their express consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to absolute or relative MRI (in particular, pregnant or breastfeeding&#xD;
             women)&#xD;
&#xD;
          -  History of intracranial surgery&#xD;
&#xD;
          -  MRI performed under general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sidney KRYSTAL</last_name>
    <role>Principal Investigator</role>
    <affiliation>Adolphe de Rothschild Fondation Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sidney KRYSTAL</last_name>
    <phone>01 48 03 65 65</phone>
    <phone_ext>+ 33</phone_ext>
    <email>skrystal@for.paris</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amelie YAVCHITZ</last_name>
    <phone>01 48 03 65 65</phone>
    <phone_ext>+ 33</phone_ext>
    <email>ayavchitz@for.paris</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fondation A De Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amelie YAVCHITZ</last_name>
      <phone>0148036431</phone>
      <email>ayavchitz@for.paris</email>
    </contact>
    <investigator>
      <last_name>Sidney KRYSTAL</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</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/NCT04451278
org study id: 2020-A01561-38
nct id: NCT04451278
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting
      networks. It allows, without active participation of the patients, to identify and analyze
      the different functional brain networks. The analysis of r-fMRI can be done thanks to the
      graph theory, which is based on the based on the calculation of quantifiable parameters
      applied to the functional network studied, making it possible to assess its effectiveness.

      To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data
      in order to obtain parameters useful for the useful parameters for the individual prognosis
      of children who have to be operation for drug-resistant lesional epilepsy.
observational model: Case-Only
time perspective: Prospective
measure: Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy.
time frame: One year
description: The variables measured with functional MRI will correspond to topological parameters of functional connectivity measured locally at the level of the lesion: the degree, the clustering coefficient and path length. Surgical success will be evaluated by a score of 1 on the modified Engel classification at one year after surgery.
arm group label: Resting-state functional MRI (r-fMRI)
description: The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional fMRI-r sequence, called resting state, and performed before injection of gadoline contrast.
A neuropsychological evaluation is performed as part of the 6 months prior to the procedure. These data will be used as a basis for the evaluation of language visual and language recovery.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
last name: Sidney KRYSTAL
role: Principal Investigator
affiliation: Adolphe de Rothschild Fondation Hospital
last name: Sidney KRYSTAL
phone: 01 48 03 65 65
phone ext: + 33
email: skrystal@for.paris
last name: Amelie YAVCHITZ
phone: 01 48 03 65 65
phone ext: + 33
email: ayavchitz@for.paris
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Drug Resistant Epilepsy
sharing ipd: No