<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/NCT02265094</url>
  </required_header>
  <id_info>
    <org_study_id>2014- A00481-46</org_study_id>
    <nct_id>NCT02265094</nct_id>
  </id_info>
  <brief_title>Associative Memory in Autism Spectrum Disorder</brief_title>
  <acronym>MEM-TA</acronym>
  <official_title>Associative Memory in ASD Without Mental Retardation : Study in EEG and Neuropsychology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amiens University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the neural substrates of associative memory in Autism&#xD;
      Spectrum Disorder using both behavioural and EEG assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 22, 2015</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Index of discrimination obtained with the task of associative memory</measure>
    <time_frame>4 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Autistic Disorder</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electroencephalography and neuropsychological tests in children with autism</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electroencephalography and neuropsychological tests in children without autism</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electroencephalography</intervention_name>
    <description>EEG recordings during memory tests</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neuropsychological assessment</intervention_name>
    <description>patterns of eye gaze during cognitive tests</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Right handed children from 10 to 18 years old&#xD;
&#xD;
          -  Informed consent signed by the legal representative and adolescent himself.&#xD;
&#xD;
          -  Medical Examinations, psychopathology, and cognitive examination in accordance with&#xD;
             inclusion and exclusion criteria specific to each population:&#xD;
&#xD;
               -  People with ASD:&#xD;
&#xD;
                    -  Participants with ASD without mental retardation with a diagnosis in&#xD;
                       reference to the DSM V criteria&#xD;
&#xD;
               -  Controls : Participants without ASD&#xD;
&#xD;
        Main exclusion criteria:&#xD;
&#xD;
          -  mental retardation,&#xD;
&#xD;
          -  schizophrenia,&#xD;
&#xD;
          -  ADHD,&#xD;
&#xD;
          -  head injury with lost of consciousness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Marc BALEYTE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Caen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bérengère GUILLERY-GIRARD, PhD</last_name>
    <phone>0231064347</phone>
    <email>berengere.guillery@unicaen.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Baleyte Jean Marc</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>February 19, 2018</last_update_submitted>
  <last_update_submitted_qc>February 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autism Spectrum Disorder</keyword>
  <keyword>Development</keyword>
  <keyword>Memory</keyword>
  <keyword>ERD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Autistic Disorder</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/NCT02265094
org study id: 2014- A00481-46
nct id: NCT02265094
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of this study is to investigate the neural substrates of associative memory in Autism
      Spectrum Disorder using both behavioural and EEG assessments.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Index of discrimination obtained with the task of associative memory
time frame: 4 years
arm group label: Patients
arm group type: Experimental
description: Electroencephalography and neuropsychological tests in children with autism
arm group label: Control
arm group type: Experimental
description: Electroencephalography and neuropsychological tests in children without autism
intervention type: Other
intervention name: Electroencephalography
description: EEG recordings during memory tests
arm group label: Control
arm group label: Patients
intervention type: Behavioral
intervention name: Neuropsychological assessment
description: patterns of eye gaze during cognitive tests
arm group label: Control
arm group label: Patients
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Marc BALEYTE, MD
role: Principal Investigator
affiliation: University Hospital, Caen
last name: Bérengère GUILLERY-GIRARD, PhD
phone: 0231064347
email: berengere.guillery@unicaen.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Autism Spectrum Disorder
mesh term: Autistic Disorder