<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/NCT02236832</url>
  </required_header>
  <id_info>
    <org_study_id>C14-17'</org_study_id>
    <secondary_id>140662B-31</secondary_id>
    <secondary_id>2014-A00649-38</secondary_id>
    <nct_id>NCT02236832</nct_id>
  </id_info>
  <brief_title>Study of the Neural Basis of Analogical Reasoning</brief_title>
  <acronym>ANALOG</acronym>
  <official_title>Organisation du Cortex préfrontal ventrolatéral Pour l'Analogie: Approche Bimodale Chez le Sujet Sain et Chez le Patient Ayant un Syndrome Frontal.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation pour la Recherche Médicale</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Frontal patients are impaired in categorisation and analogical reasoning tasks, and different&#xD;
      functional imaging studies from our group have shown the involvement of the prefrontal cortex&#xD;
      in categorisation and analogy tasks. The aim of this project is to test our hypotheses about&#xD;
      the role of the prefrontal cortex in explicit and implicit categorisation and analogy tasks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">February 2021</completion_date>
  <primary_completion_date type="Actual">February 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance in the implicat task</measure>
    <time_frame>day of inclusion (one day)</time_frame>
    <description>Reaction time and accuracy will be registered for this categorization task. This task will be used in patients with FTD and in healthy controls (n=60).&#xD;
Participants will come only once during one day ot the research centre.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance in the Similitude task</measure>
    <time_frame>from inclusion to 4 months after inclusion</time_frame>
    <description>Reaction time and accuracy will be recorded while healthy subjects perform this categorization task, after a session of rTMS or during on line TMS (n=40).&#xD;
Participants will come 3 to 5 times at the research centre in a maximum period of 4 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>recording of EEG</measure>
    <time_frame>day of inclusion (one day)</time_frame>
    <description>EEG will be recorded in patients with FTD and in healthy controls for an analysis of event related potentials.&#xD;
Participants will come only once during one day a the research centre.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of MRI</measure>
    <time_frame>day of inclusion (one day)</time_frame>
    <description>T1 MRI will be recorded for VBM analysis in patients with FTD and healthy controls.&#xD;
Participants will come only once during one day at the research centre</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Frontotemporal Dementia</condition>
  <condition>Progressive Supranuclear Palsy</condition>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>FTD (frontotemporal dementia) patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fronto-temporal demential patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PSP patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>progressive supra nuclear palsy patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>healthy control education matched, age matched and sex matched with PSP and FTD patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>healthy participants that will participate to the TMS study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy young participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy participants will be included for an EEG study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial magnetic stimulation</intervention_name>
    <arm_group_label>healthy participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI imaging</intervention_name>
    <arm_group_label>FTD (frontotemporal dementia) patients</arm_group_label>
    <arm_group_label>PSP patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_label>healthy participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EEG recording</intervention_name>
    <arm_group_label>FTD (frontotemporal dementia) patients</arm_group_label>
    <arm_group_label>PSP patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_label>healthy participants</arm_group_label>
    <arm_group_label>healthy young participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neuropsychological examination</intervention_name>
    <arm_group_label>FTD (frontotemporal dementia) patients</arm_group_label>
    <arm_group_label>PSP patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_label>healthy participants</arm_group_label>
    <arm_group_label>healthy young participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy subjects:&#xD;
&#xD;
          -  subject affiliated to national health insurance&#xD;
&#xD;
          -  informed consent signed&#xD;
&#xD;
          -  normal neurological examination&#xD;
&#xD;
          -  subject aged at least 20&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  FTD or PSP diagnostic criteria filled&#xD;
&#xD;
          -  patient affiliated to national health insurance&#xD;
&#xD;
          -  informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric symptomatology and psychotropic drug use&#xD;
&#xD;
          -  unability to understand or perform the cognitive tasks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Levy, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut du Cerveau et de la Moelle épinière, Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICM (Institut du cerveau et de la Moelle épinière)</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</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>Frontotemporal Dementia</mesh_term>
    <mesh_term>Aphasia, Primary Progressive</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Supranuclear Palsy, Progressive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD sharing will be only performed on individual request for a specified study.</ipd_description>
  </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/NCT02236832
org study id: C14-17'
secondary id: 140662B-31
secondary id: 2014-A00649-38
nct id: NCT02236832
lead sponsor: 
collaborator: 
has dmc: No
Frontal patients are impaired in categorisation and analogical reasoning tasks, and different
      functional imaging studies from our group have shown the involvement of the prefrontal cortex
      in categorisation and analogy tasks. The aim of this project is to test our hypotheses about
      the role of the prefrontal cortex in explicit and implicit categorisation and analogy tasks.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Performance in the implicat task
time frame: day of inclusion (one day)
description: Reaction time and accuracy will be registered for this categorization task. This task will be used in patients with FTD and in healthy controls (n=60).
Participants will come only once during one day ot the research centre.
measure: Performance in the Similitude task
time frame: from inclusion to 4 months after inclusion
description: Reaction time and accuracy will be recorded while healthy subjects perform this categorization task, after a session of rTMS or during on line TMS (n=40).
Participants will come 3 to 5 times at the research centre in a maximum period of 4 months.
measure: recording of EEG
time frame: day of inclusion (one day)
description: EEG will be recorded in patients with FTD and in healthy controls for an analysis of event related potentials.
Participants will come only once during one day a the research centre.
measure: Analysis of MRI
time frame: day of inclusion (one day)
description: T1 MRI will be recorded for VBM analysis in patients with FTD and healthy controls.
Participants will come only once during one day at the research centre
arm group label: FTD (frontotemporal dementia) patients
arm group type: Experimental
description: fronto-temporal demential patients
arm group label: PSP patients
arm group type: Experimental
description: progressive supra nuclear palsy patients
arm group label: healthy controls
arm group type: Active Comparator
description: healthy control education matched, age matched and sex matched with PSP and FTD patients
arm group label: healthy participants
arm group type: Experimental
description: healthy participants that will participate to the TMS study.
arm group label: healthy young participants
arm group type: Experimental
description: Healthy participants will be included for an EEG study
intervention type: Device
intervention name: transcranial magnetic stimulation
arm group label: healthy participants
intervention type: Other
intervention name: MRI imaging
arm group label: FTD (frontotemporal dementia) patients
arm group label: PSP patients
arm group label: healthy controls
arm group label: healthy participants
intervention type: Other
intervention name: EEG recording
arm group label: FTD (frontotemporal dementia) patients
arm group label: PSP patients
arm group label: healthy controls
arm group label: healthy participants
arm group label: healthy young participants
intervention type: Behavioral
intervention name: Neuropsychological examination
arm group label: FTD (frontotemporal dementia) patients
arm group label: PSP patients
arm group label: healthy controls
arm group label: healthy participants
arm group label: healthy young participants
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Levy, MD, PhD
role: Principal Investigator
affiliation: Institut du Cerveau et de la Moelle épinière, Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Frontotemporal Dementia
mesh term: Aphasia, Primary Progressive
mesh term: Pick Disease of the Brain
mesh term: Supranuclear Palsy, Progressive
sharing ipd: Undecided
ipd description: IPD sharing will be only performed on individual request for a specified study.