<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/NCT03799497</url>
  </required_header>
  <id_info>
    <org_study_id>2009_48</org_study_id>
    <secondary_id>2010-A00545-34</secondary_id>
    <nct_id>NCT03799497</nct_id>
  </id_info>
  <brief_title>Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental</brief_title>
  <acronym>Explorexie</acronym>
  <official_title>Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa, an fMRI Activation Study</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>
      Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering&#xD;
      from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be&#xD;
      at the origin of a reinforcement of anorectic behavior which might alter medical care. The&#xD;
      objective of this study is to identify neural correlates of self-recognition in Anorexia&#xD;
      Nervosa. Patients are hypothesized to activate the self-recognition network when seeing&#xD;
      images of a fatter body shape than their own.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients suffering from Anorexia Nervosa and control subjects (matched by age and study&#xD;
      level) are recruited in medical care facilities in Lille's Metropolis. They are asked to&#xD;
      identify their body shape when being presented with 3 different stimuli, i.e.real (RBS),&#xD;
      estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or&#xD;
      functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to&#xD;
      identify modifications in the self body-recognition network.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2013</start_date>
  <completion_date type="Actual">June 7, 2020</completion_date>
  <primary_completion_date type="Actual">June 7, 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>Measure of the activation brain areas in self body-recognition network</measure>
    <time_frame>15 days</time_frame>
    <description>Level of activation areas in the self body-recognition network measured during fMRI</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Patients suffering from Anorexia Nervosa</arm_group_label>
    <description>Subjects with a diagnostic of anorexia nervosa disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Healthy subjects with no psychiatric disorder</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Volontary subjects : patients suffering from Anorexia Nervosa and control subjects, matched&#xD;
        by age and study level&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Providing informed, dated and signed consent (for minors, consent must be signed by&#xD;
             both parents)&#xD;
&#xD;
          -  With medical insurance&#xD;
&#xD;
          -  With normal vision&#xD;
&#xD;
          -  Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least&#xD;
             one year and with a Body Masse index (BMI) between 14 and 18&#xD;
&#xD;
          -  Only for the control Group : BMI between 18 and 25 and without any psychiatric&#xD;
             disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  With antecedent or current neurologic disease&#xD;
&#xD;
          -  With antecedent or current ophthalmologic disease&#xD;
&#xD;
          -  Contraindication for IRMf&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier Cottencin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU,Hôpital Fontan 2</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>September 15, 2020</last_update_submitted>
  <last_update_submitted_qc>September 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anorexia nervosa</keyword>
  <keyword>functional MRI (fMRI)</keyword>
  <keyword>self body-shape recognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Anorexia Nervosa</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/NCT03799497
org study id: 2009_48
secondary id: 2010-A00545-34
nct id: NCT03799497
lead sponsor: 
has dmc: No
Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering
      from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be
      at the origin of a reinforcement of anorectic behavior which might alter medical care. The
      objective of this study is to identify neural correlates of self-recognition in Anorexia
      Nervosa. Patients are hypothesized to activate the self-recognition network when seeing
      images of a fatter body shape than their own.
Patients suffering from Anorexia Nervosa and control subjects (matched by age and study
      level) are recruited in medical care facilities in Lille's Metropolis. They are asked to
      identify their body shape when being presented with 3 different stimuli, i.e.real (RBS),
      estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or
      functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to
      identify modifications in the self body-recognition network.
observational model: Case-Control
time perspective: Prospective
measure: Measure of the activation brain areas in self body-recognition network
time frame: 15 days
description: Level of activation areas in the self body-recognition network measured during fMRI
arm group label: Patients suffering from Anorexia Nervosa
description: Subjects with a diagnostic of anorexia nervosa disorder
arm group label: Control group
description: Healthy subjects with no psychiatric disorder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Olivier Cottencin, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa
sharing ipd: No