xml: <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/NCT06035965</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/23/0411</org_study_id>
      <nct_id>NCT06035965</nct_id>
    </id_info>
    <brief_title>Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery</brief_title>
    <acronym>EPICHANGE</acronym>
    <official_title>Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery, With Long-term Epileptological Objective Results</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</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>
        Epilepsy is one of the most common chronic neurological diseases. According to data from the&#xD;
        World Health Organization (WHO), it affects 0.5 to 1% of the population, or around 70 million&#xD;
        people world-wide and around 600,000 in France. There are several more or less severe forms&#xD;
        of epilepsy depending on the type of epileptic seizures and the frequency of these seizures.&#xD;
        About 30% of epileptic patients respond poorly to well-conducted medical treatment, which&#xD;
        makes the number of so-called &quot;drug-resistant&quot; patients estimated at between 100,000 and&#xD;
        150,000 patients.&#xD;
  &#xD;
        Epilepsy surgery is possible in some cases of drug-resistant epilepsy and can lead to&#xD;
        complete seizure control. Beyond the impact on the control of seizures, surgery can have an&#xD;
        impact on the lives of patients at the psychological, emotional and cognitive level, with&#xD;
        consequences on their socio-professional but also personal life. Thus the impact on the daily&#xD;
        life of patients after epilepsy surgery can vary greatly from one patient to another and the&#xD;
        personal feelings of operated patients do not always seem to correspond to the objective&#xD;
        elements collected by doctors. 2.3 We want to retrospectively assess the satisfaction and&#xD;
        quality of life of patients operated on for more than 2 years based on their epileptological&#xD;
        results (frequency of seizures).&#xD;
  &#xD;
        To our knowledge, no French study has yet studied this.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of the changes felt by patients</measure>
      <time_frame>2 years</time_frame>
      <description>Evaluate the changes felt by patients more than 2 years after surgery in the context of drug-resistant epilepsy using a new questionnaire created by the epileptology team of the Toulouse University Hospital.</description>
    </primary_outcome>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Epilepsy</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19)</intervention_name>
      <description>19 items assessing post-surgery satisfaction.</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Quality of Life in Epilepsy Inventory (QOLIE-31)</intervention_name>
      <description>31 items to assess different dimensions of quality of life</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Generalized Anxiety Disorder 7 (GAD7)</intervention_name>
      <description>7 items, rated from 0 to 3, to detect anxiety disorders.</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)</intervention_name>
      <description>to screen for depressive disorders</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Evaluation of Changes in Daily Life after Epilepsy Surgery (EVOCQUE)</intervention_name>
      <description>self-questionnaire developed by the Toulouse epileptology team in 2023 for patients who have undergone epilepsy surgery. It aims to collect the feelings of patients concerning the changes induced by surgery in their daily life according to a 7-point Likert scale.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient operated in the context of epilepsy surgery dating back more than 2 years in the&#xD;
          epileptology center of the Toulouse University Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient operated in the context of epilepsy surgery dating back more than 2 years in&#xD;
               the epileptology center of the Toulouse University Hospital.&#xD;
  &#xD;
            -  Patient covered by a social security scheme.&#xD;
  &#xD;
            -  Patient having given his non-objection to participate in the research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Minor under the age of 15 at the time of the questionnaires.&#xD;
  &#xD;
            -  Serious psychiatric pathology unrelated to epilepsy surgery.&#xD;
  &#xD;
            -  Severe intellectual disability limiting responses to self-questionnaires.&#xD;
  &#xD;
            -  Language barrier.&#xD;
  &#xD;
            -  Patients under guardianship and protection of justice.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>HELENE MIRABEL</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>HELENE MIRABEL</last_name>
      <phone>05 61 77 56 14</phone>
      <phone_ext>+33</phone_ext>
      <email>mirabel.h@chu-toulouse.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>AMAURY DE BARROS</last_name>
      <phone>05 61 77 90 27</phone>
      <phone_ext>+33</phone_ext>
      <email>debarros.a@chu-toulouse.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU de Toulouse</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>HELENE MIRABEL</last_name>
        <email>MIRABEL.H@CHU-TOULOUSE.FR</email>
      </contact>
      <contact_backup>
        <last_name>AMAURY DE BARROS</last_name>
        <email>debarros.a@chu-toulouse.fr</email>
      </contact_backup>
      <investigator>
        <last_name>HELENE MIRABEL</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>AMAURY DE BARROS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>MARIE DENUELLE</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>LUC VALTON</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>JONATHAN CUROT</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035965
  org study id: RC31/23/0411
  nct id: NCT06035965
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Epilepsy is one of the most common chronic neurological diseases. According to data from the
        World Health Organization (WHO), it affects 0.5 to 1% of the population, or around 70 million
        people world-wide and around 600,000 in France. There are several more or less severe forms
        of epilepsy depending on the type of epileptic seizures and the frequency of these seizures.
        About 30% of epileptic patients respond poorly to well-conducted medical treatment, which
        makes the number of so-called "drug-resistant" patients estimated at between 100,000 and
        150,000 patients.
  
        Epilepsy surgery is possible in some cases of drug-resistant epilepsy and can lead to
        complete seizure control. Beyond the impact on the control of seizures, surgery can have an
        impact on the lives of patients at the psychological, emotional and cognitive level, with
        consequences on their socio-professional but also personal life. Thus the impact on the daily
        life of patients after epilepsy surgery can vary greatly from one patient to another and the
        personal feelings of operated patients do not always seem to correspond to the objective
        elements collected by doctors. 2.3 We want to retrospectively assess the satisfaction and
        quality of life of patients operated on for more than 2 years based on their epileptological
        results (frequency of seizures).
  
        To our knowledge, no French study has yet studied this.
  observational model: Cohort
  time perspective: Prospective
  measure: Evaluation of the changes felt by patients
  time frame: 2 years
  description: Evaluate the changes felt by patients more than 2 years after surgery in the context of drug-resistant epilepsy using a new questionnaire created by the epileptology team of the Toulouse University Hospital.
  intervention type: Other
  intervention name: Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19)
  description: 19 items assessing post-surgery satisfaction.
  intervention type: Other
  intervention name: Quality of Life in Epilepsy Inventory (QOLIE-31)
  description: 31 items to assess different dimensions of quality of life
  intervention type: Other
  intervention name: Generalized Anxiety Disorder 7 (GAD7)
  description: 7 items, rated from 0 to 3, to detect anxiety disorders.
  intervention type: Other
  intervention name: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
  description: to screen for depressive disorders
  intervention type: Other
  intervention name: Evaluation of Changes in Daily Life after Epilepsy Surgery (EVOCQUE)
  description: self-questionnaire developed by the Toulouse epileptology team in 2023 for patients who have undergone epilepsy surgery. It aims to collect the feelings of patients concerning the changes induced by surgery in their daily life according to a 7-point Likert scale.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: N/A
  healthy volunteers: No
  last name: HELENE MIRABEL
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  last name: HELENE MIRABEL
  phone: 05 61 77 56 14
  phone ext: +33
  email: mirabel.h@chu-toulouse.fr
  last name: AMAURY DE BARROS
  phone: 05 61 77 90 27
  phone ext: +33
  email: debarros.a@chu-toulouse.fr
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Epilepsy
  sharing ipd: No