<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/NCT02989116</url>
  </required_header>
  <id_info>
    <org_study_id>2015-A00383-46</org_study_id>
    <secondary_id>15-045</secondary_id>
    <nct_id>NCT02989116</nct_id>
  </id_info>
  <brief_title>Executive Training and Brain in Children</brief_title>
  <acronym>APEX</acronym>
  <official_title>Executive Training and Brain in School-Age Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Agency, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a daily executive training to cognitive&#xD;
      inhibition, working memory or mindfulness as compared to an active control condition has a&#xD;
      near- and far-transfer impact on brain and behavioral measures as collected in children aged&#xD;
      9-10 years, either born preterm or full-term.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2015</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning.</measure>
    <time_frame>3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)</time_frame>
    <description>Change in brain activation will be measured with functional magnetic resonance imaging (fMRI) during two different tasks: a Stop Signal task assessing inhibition and a Dot task assessing working memory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in brain cortical structure after one month of executive training as assessed by anatomical MRI in regions subtending executive functioning.</measure>
    <time_frame>3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)</time_frame>
    <description>Change in brain cortical structure will be measured with anatomical magnetic resonance imaging (aMRI) using four different measures:&#xD;
2.a. grey matter volume 2.b. cortical thickness 2.c. cortical surface area 2.d. curvature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cognitive behavioral measures after one month of executive training as assessed by cognitive testing</measure>
    <time_frame>3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)</time_frame>
    <description>The cognitive testing session includes several tasks assessing executive functioning under different conditions. Will be investigated:&#xD;
3.a. Response Time 3.b. Accuracy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sulcal morphometry measured by anatomical MRI</measure>
    <time_frame>Pretest (t0)</time_frame>
    <description>Assessing the impact of the early determined sulcal morphometry on behavioral and brain changes associated to a one-month executive training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping</measure>
    <time_frame>Pretest (t0)</time_frame>
    <description>Assessing the impact of the different genotypes on behavioral and brain changes associated to a one-month executive training.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Healthy Children</condition>
  <condition>Preterm Birth</condition>
  <arm_group>
    <arm_group_label>Preterm Inhibition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In children born very preterm:&#xD;
Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full-term Inhibition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In children born full-term:&#xD;
Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full-term Working memory</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In children born full-term:&#xD;
Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full-term Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In children born full-term:&#xD;
Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full-term Active control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In children born full-term:&#xD;
Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Inhibition training</intervention_name>
    <description>Inhibition training on a tactile tablet for a month (20 sessions of 15 min)</description>
    <arm_group_label>Full-term Inhibition</arm_group_label>
    <arm_group_label>Preterm Inhibition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Working memory training</intervention_name>
    <description>Working memory training on a tactile tablet for a month (20 sessions of 15 min)</description>
    <arm_group_label>Full-term Working memory</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness training</intervention_name>
    <description>Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)</description>
    <arm_group_label>Full-term Mindfulness</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active control training</intervention_name>
    <description>Active control training on a tactile tablet for a month (20 sessions of 15 min)</description>
    <arm_group_label>Full-term Active control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Saliva collection</intervention_name>
    <description>Collection of a saliva sample for genotyping</description>
    <arm_group_label>Full-term Active control</arm_group_label>
    <arm_group_label>Full-term Inhibition</arm_group_label>
    <arm_group_label>Full-term Mindfulness</arm_group_label>
    <arm_group_label>Full-term Working memory</arm_group_label>
    <arm_group_label>Preterm Inhibition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Brain Magnetic Resonance Imaging</intervention_name>
    <description>Structural and functional MRI</description>
    <arm_group_label>Full-term Active control</arm_group_label>
    <arm_group_label>Full-term Inhibition</arm_group_label>
    <arm_group_label>Full-term Mindfulness</arm_group_label>
    <arm_group_label>Full-term Working memory</arm_group_label>
    <arm_group_label>Preterm Inhibition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive testing</intervention_name>
    <description>Battery of cognitive and academic tasks on executive functions</description>
    <arm_group_label>Full-term Active control</arm_group_label>
    <arm_group_label>Full-term Inhibition</arm_group_label>
    <arm_group_label>Full-term Mindfulness</arm_group_label>
    <arm_group_label>Full-term Working memory</arm_group_label>
    <arm_group_label>Preterm Inhibition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for all children:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Aged 9-10 years at inclusion&#xD;
&#xD;
          -  French school curriculum (since 1st grade)&#xD;
&#xD;
          -  Fully informed through the dedicated booklet&#xD;
&#xD;
          -  Both parents gave their written consent&#xD;
&#xD;
          -  Normal medical, neurological and brain imaging assessment&#xD;
&#xD;
        Inclusion criterion for non preterm children only:&#xD;
&#xD;
        - Full term pregnancy with no abnormal event (&gt;= 37 weeks of amenorrhea)&#xD;
&#xD;
        Inclusion criterion for preterm children only:&#xD;
&#xD;
        - Delivery before 33 weeks of amenorrhea&#xD;
&#xD;
        Exclusion Criteria for all participants:&#xD;
&#xD;
          -  Age over or under 9-10 years old at inclusion&#xD;
&#xD;
          -  Monozygotic twins&#xD;
&#xD;
          -  Restrictions to a Magnetic Resonance brain imaging exam: claustrophobia, metallic&#xD;
             elements (cardiac implants, cochlear implants, metallic elements in the brain or the&#xD;
             eyes and being close to the nervous system, metallic prothesis, braces), restless&#xD;
             participants.&#xD;
&#xD;
          -  Sudden cognitive impairments due to a stroke, head injury associated with loss of&#xD;
             consciousness for more than one hour or encephalitis.&#xD;
&#xD;
          -  Chronic neurological, psychiatric, infectious or liver condition, endocrine&#xD;
             disruption.&#xD;
&#xD;
          -  Past or current medical condition: cancer, diabetes, chronic lung condition, cardiac,&#xD;
             metabolic, hematological, endocrine or immunological disorder.&#xD;
&#xD;
          -  Medication assumed to interfere with brain imaging measures (psychotropics, hypnotics,&#xD;
             anxiolytics, neuroleptics, benzodiazepine, steroidal anti-inflammatory,&#xD;
             anti-epileptics, painkillers, muscle relaxants).&#xD;
&#xD;
          -  Left-sided handedness&#xD;
&#xD;
          -  Colour blindness or non-corrected visual disturbances&#xD;
&#xD;
          -  Diagnosed developmental disorders&#xD;
&#xD;
          -  Diagnosed cerebral palsy&#xD;
&#xD;
          -  Diagnosed Fine motor disturbances&#xD;
&#xD;
          -  Parents not affiliated to the Social Security&#xD;
&#xD;
          -  Parents not able to join at each time of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier Houdé, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Paris 5 - Rene Descartes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bernard Guillois, Professor</last_name>
    <phone>02.31.25.27.64</phone>
    <phone_ext>+33</phone_ext>
    <email>guillois-b@chu-caen.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Olivier Houdé, Professor</last_name>
    <phone>01.40.46.29.95</phone>
    <phone_ext>+33</phone_ext>
    <email>olivier.houde@parisdescartes.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GIP Cyceron</name>
      <address>
        <city>Caen</city>
        <zip>14074</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier Houdé, Professor</last_name>
      <phone>01.40.46.29.95</phone>
      <phone_ext>+33</phone_ext>
      <email>olivier.houde@parisdescartes.fr</email>
    </contact>
    <contact_backup>
      <last_name>Grégoire Borst, Professor</last_name>
      <phone>01.40.46.30.04</phone>
      <phone_ext>+33</phone_ext>
      <email>gregoire.borst@parisdescartes.fr</email>
    </contact_backup>
    <investigator>
      <last_name>François Orliac, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Valérie Datin-Dorrière, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>May 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Learning</keyword>
  <keyword>Executive functions</keyword>
  <keyword>Cognitive control</keyword>
  <keyword>Prefrontal Cortex</keyword>
  <keyword>Typically developing children</keyword>
  <keyword>Genotype</keyword>
  <keyword>Functional Magnetic Resonance Imaging</keyword>
  <keyword>Structural Magnetic Resonance Imaging</keyword>
  <keyword>Inhibition</keyword>
  <keyword>Working Memory</keyword>
  <keyword>Metacognition</keyword>
  <keyword>Mindfulness</keyword>
  <keyword>Preterm children</keyword>
  <keyword>Developmental Psychology</keyword>
  <keyword>Developmental cognitive neuroscience</keyword>
  <keyword>Touch screen tablet</keyword>
  <keyword>Adaptive training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02989116
org study id: 2015-A00383-46
secondary id: 15-045
nct id: NCT02989116
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether a daily executive training to cognitive
      inhibition, working memory or mindfulness as compared to an active control condition has a
      near- and far-transfer impact on brain and behavioral measures as collected in children aged
      9-10 years, either born preterm or full-term.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in brain functional BOLD activity after one month of executive training as assessed by MRI in regions subtending executive functioning.
time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
description: Change in brain activation will be measured with functional magnetic resonance imaging (fMRI) during two different tasks: a Stop Signal task assessing inhibition and a Dot task assessing working memory.
measure: Change in brain cortical structure after one month of executive training as assessed by anatomical MRI in regions subtending executive functioning.
time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
description: Change in brain cortical structure will be measured with anatomical magnetic resonance imaging (aMRI) using four different measures:
2.a. grey matter volume 2.b. cortical thickness 2.c. cortical surface area 2.d. curvature
measure: Change in cognitive behavioral measures after one month of executive training as assessed by cognitive testing
time frame: 3 months: Pretest (t0), immediate Post-test (t0+1 month), deferred post-test (t0+3 months)
description: The cognitive testing session includes several tasks assessing executive functioning under different conditions. Will be investigated:
3.a. Response Time 3.b. Accuracy
measure: Sulcal morphometry measured by anatomical MRI
time frame: Pretest (t0)
description: Assessing the impact of the early determined sulcal morphometry on behavioral and brain changes associated to a one-month executive training.
measure: Genetic variations measured by Single Nucleotide Polymorphism (SNP) genotyping
time frame: Pretest (t0)
description: Assessing the impact of the different genotypes on behavioral and brain changes associated to a one-month executive training.
arm group label: Preterm Inhibition
arm group type: Experimental
description: In children born very preterm:
Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
arm group label: Full-term Inhibition
arm group type: Experimental
description: In children born full-term:
Inhibition training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
arm group label: Full-term Working memory
arm group type: Experimental
description: In children born full-term:
Working memory training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
arm group label: Full-term Mindfulness
arm group type: Experimental
description: In children born full-term:
Mindfulness training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
arm group label: Full-term Active control
arm group type: Active Comparator
description: In children born full-term:
Active control training, Saliva collection, Brain Magnetic Resonance Imaging, Cognitive testing
intervention type: Behavioral
intervention name: Inhibition training
description: Inhibition training on a tactile tablet for a month (20 sessions of 15 min)
arm group label: Full-term Inhibition
arm group label: Preterm Inhibition
intervention type: Behavioral
intervention name: Working memory training
description: Working memory training on a tactile tablet for a month (20 sessions of 15 min)
arm group label: Full-term Working memory
intervention type: Behavioral
intervention name: Mindfulness training
description: Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)
arm group label: Full-term Mindfulness
intervention type: Behavioral
intervention name: Active control training
description: Active control training on a tactile tablet for a month (20 sessions of 15 min)
arm group label: Full-term Active control
intervention type: Genetic
intervention name: Saliva collection
description: Collection of a saliva sample for genotyping
arm group label: Full-term Active control
arm group label: Full-term Inhibition
arm group label: Full-term Mindfulness
arm group label: Full-term Working memory
arm group label: Preterm Inhibition
intervention type: Procedure
intervention name: Brain Magnetic Resonance Imaging
description: Structural and functional MRI
arm group label: Full-term Active control
arm group label: Full-term Inhibition
arm group label: Full-term Mindfulness
arm group label: Full-term Working memory
arm group label: Preterm Inhibition
intervention type: Behavioral
intervention name: Cognitive testing
description: Battery of cognitive and academic tasks on executive functions
arm group label: Full-term Active control
arm group label: Full-term Inhibition
arm group label: Full-term Mindfulness
arm group label: Full-term Working memory
arm group label: Preterm Inhibition
criteria: 
gender: All
minimum age: 9 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Olivier Houdé, Professor
role: Principal Investigator
affiliation: University of Paris 5 - Rene Descartes
last name: Bernard Guillois, Professor
phone: 02.31.25.27.64
phone ext: +33
email: guillois-b@chu-caen.fr
last name: Olivier Houdé, Professor
phone: 01.40.46.29.95
phone ext: +33
email: olivier.houde@parisdescartes.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: Undecided