<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/NCT03286387</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0404</org_study_id>
    <secondary_id>2017-A02558-45</secondary_id>
    <nct_id>NCT03286387</nct_id>
  </id_info>
  <brief_title>Contextual Associations During Episodic Recall of Everyday or Virtual Reality</brief_title>
  <acronym>BREAL</acronym>
  <official_title>Contextual Associations During Episodic Recall of Everyday or Virtual Reality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      The project is dedicated to development of new paradigms to investigate memory and attention&#xD;
      in the rich and realistic environments. The investigator will use modern interactive digital&#xD;
      technologies for encoding complex episodes either using mobile phone technology in everyday&#xD;
      life or using a virtual reality life-like simulation.&#xD;
&#xD;
      He aims to characterize the role of the medial temporal lobe and prefrontal cortex during&#xD;
      recall of naturalistic episodic experiences, using functional neuroimaging (fMRI) in healthy&#xD;
      participants. The secondary aim is assess how the allocation of attention during memory&#xD;
      encoding contribute to mechanisms of the subsequent recall. He will achieve this by&#xD;
      monitoring gaze direction during encoding and by analyzing the retrieval data as a function&#xD;
      of the elements that participants attended / fixated during encoding.&#xD;
&#xD;
      The protocol will involve, first, behavioral testing of memory performance with encoding in&#xD;
      the real-life or in virtual reality, followed by the main hypothesis testing phase when fMRI&#xD;
      will be used to measure brain activity during retrieval.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2018</start_date>
  <completion_date type="Actual">August 13, 2019</completion_date>
  <primary_completion_date type="Actual">August 13, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BOLD cerebral response to contextual recall in medial temporal lobe</measure>
    <time_frame>up to 1 week after the end of the encoding session</time_frame>
    <description>After spatial preprocessing of individual series of EPI fMRI images, normalization and smoothing as suggested for SPM analysis, the successful and failed contextual recall will be modeled and convolved with canonical HRF function. The GLM will be estimated according to the algorithm of SPM, the significance threshold will be p&lt;0.05 FWE within the regions of interest. Our hypothesis will be confirmed by activation of medial temporal lobe and prefrontal cortex in contextual recall, congruent contextual cueing and recall of episodes when targets were semantically congruent with the context at encoding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BOLD cerebral response to contextual recall in prefrontal cortex</measure>
    <time_frame>up to 1 week after the end of the encoding session</time_frame>
    <description>After spatial preprocessing of individual series of EPI fMRI images, normalization and smoothing as suggested for Statistical Parametric Mapping (SPM) analysis, the successful and failed contextual recall will be modeled and convolved with canonical HRF function. The GLM will be estimated according to the algorithm of SPM, the significance threshold will be p&lt;0.05 Family-wise error (FWE) within the regions of interest. Our hypothesis will be confirmed by activation of medial temporal lobe and prefrontal cortex in contextual recall, congruent contextual cueing and recall of episodes when targets were semantically congruent with the context at encoding.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pattern of gaze fixation during episodic encoding and cerebral activity during recall</measure>
    <time_frame>up to 1 week after the end of the encoding session</time_frame>
    <description>The gaze direction during both during episodic encoding and recall. We will estimate a correlation between the activation of medial temporal lobe/ prefrontal cortex and the similarity of the gaze fixations during encoding and retrieval. A positive correlation will support our hypothesis about the link between attention and contextual encoding.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Memory for naturalistic episodes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Encoding of episode in real life situations (using Smartphones) or in a virtual environment, followed by memory retrieval (either behavior only or with fMRI, in successive studies)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Functional brain imaging without any contrast agent</intervention_name>
    <description>During the fMRI protocol, the subject will perform the retrieval tasks while whole-brain activity will be recorded using Echo Planar Imaging (EPI) that measures the Blood Oxygen Level Dependent (BOLD) signal (2x2x2 isotropic voxels, Echo Time (TE) = 30 ms, Repetition Time (TR) = 2.5 sec). The functional session will be subdivided into several parts (&quot;Runs&quot;, duration: 10-15 min). Together with the functional data, the protocol will include a structural scan (T1 weighted, 1x1x1 mm voxels; duration 5-7 min) and a field mapping sequence (duration: 1 min).</description>
    <arm_group_label>Memory for naturalistic episodes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Possession a Smartphone compatible with GPS 3-rd generation and exploitation system&#xD;
             Android 4.2 with user-activated geolocation (for mobile phone studies).&#xD;
&#xD;
          -  Able to navigate in virtual reality with a help of the keyboard (for virtual reality&#xD;
             studies).&#xD;
&#xD;
          -  Not using glasses.&#xD;
&#xD;
          -  All subjects will give their written consent for participation in the study.&#xD;
&#xD;
          -  They will be right-handed&#xD;
&#xD;
          -  They will have French social coverage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous neurologic or psychiatric disease.&#xD;
&#xD;
          -  Cognitive deficits restricting understanding of the tasks.&#xD;
&#xD;
          -  Pregnant or breath-feeding women.&#xD;
&#xD;
          -  Persons under guardianship, curatorship or any other administrative or judicial&#xD;
             measure of deprivation of rights or liberty.&#xD;
&#xD;
          -  Subjects currently participating in other study.&#xD;
&#xD;
        Additional exclusion criteria for an fMRI recording&#xD;
&#xD;
          -  Neurologic, cardiac electrostimulation or defibrillator.&#xD;
&#xD;
          -  Cardiac prostheses&#xD;
&#xD;
          -  Intracranial clips or clamps&#xD;
&#xD;
          -  Cerebrospinal fluid disorders&#xD;
&#xD;
          -  Metal particles in the eyes&#xD;
&#xD;
          -  Metal dental or articular prostheses&#xD;
&#xD;
          -  Diffusion pomp or other infusion system&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Head tattoo , makeup, hair gel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emiliano MACALUSO, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>INSERM U1028 - Impact - CRNL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>U1028 INSERM - CNRS UMR 5292 Equipe ImpAct</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Memory</keyword>
  <keyword>naturalistic</keyword>
  <keyword>context</keyword>
  <keyword>fMRI</keyword>
  <keyword>Attention</keyword>
  <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/NCT03286387
org study id: 69HCL17_0404
secondary id: 2017-A02558-45
nct id: NCT03286387
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The project is dedicated to development of new paradigms to investigate memory and attention
      in the rich and realistic environments. The investigator will use modern interactive digital
      technologies for encoding complex episodes either using mobile phone technology in everyday
      life or using a virtual reality life-like simulation.

      He aims to characterize the role of the medial temporal lobe and prefrontal cortex during
      recall of naturalistic episodic experiences, using functional neuroimaging (fMRI) in healthy
      participants. The secondary aim is assess how the allocation of attention during memory
      encoding contribute to mechanisms of the subsequent recall. He will achieve this by
      monitoring gaze direction during encoding and by analyzing the retrieval data as a function
      of the elements that participants attended / fixated during encoding.

      The protocol will involve, first, behavioral testing of memory performance with encoding in
      the real-life or in virtual reality, followed by the main hypothesis testing phase when fMRI
      will be used to measure brain activity during retrieval.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: BOLD cerebral response to contextual recall in medial temporal lobe
time frame: up to 1 week after the end of the encoding session
description: After spatial preprocessing of individual series of EPI fMRI images, normalization and smoothing as suggested for SPM analysis, the successful and failed contextual recall will be modeled and convolved with canonical HRF function. The GLM will be estimated according to the algorithm of SPM, the significance threshold will be p<0.05 FWE within the regions of interest. Our hypothesis will be confirmed by activation of medial temporal lobe and prefrontal cortex in contextual recall, congruent contextual cueing and recall of episodes when targets were semantically congruent with the context at encoding.
measure: BOLD cerebral response to contextual recall in prefrontal cortex
time frame: up to 1 week after the end of the encoding session
description: After spatial preprocessing of individual series of EPI fMRI images, normalization and smoothing as suggested for Statistical Parametric Mapping (SPM) analysis, the successful and failed contextual recall will be modeled and convolved with canonical HRF function. The GLM will be estimated according to the algorithm of SPM, the significance threshold will be p<0.05 Family-wise error (FWE) within the regions of interest. Our hypothesis will be confirmed by activation of medial temporal lobe and prefrontal cortex in contextual recall, congruent contextual cueing and recall of episodes when targets were semantically congruent with the context at encoding.
measure: Pattern of gaze fixation during episodic encoding and cerebral activity during recall
time frame: up to 1 week after the end of the encoding session
description: The gaze direction during both during episodic encoding and recall. We will estimate a correlation between the activation of medial temporal lobe/ prefrontal cortex and the similarity of the gaze fixations during encoding and retrieval. A positive correlation will support our hypothesis about the link between attention and contextual encoding.
arm group label: Memory for naturalistic episodes
arm group type: Experimental
description: Encoding of episode in real life situations (using Smartphones) or in a virtual environment, followed by memory retrieval (either behavior only or with fMRI, in successive studies)
intervention type: Other
intervention name: Functional brain imaging without any contrast agent
description: During the fMRI protocol, the subject will perform the retrieval tasks while whole-brain activity will be recorded using Echo Planar Imaging (EPI) that measures the Blood Oxygen Level Dependent (BOLD) signal (2x2x2 isotropic voxels, Echo Time (TE) = 30 ms, Repetition Time (TR) = 2.5 sec). The functional session will be subdivided into several parts ("Runs", duration: 10-15 min). Together with the functional data, the protocol will include a structural scan (T1 weighted, 1x1x1 mm voxels; duration 5-7 min) and a field mapping sequence (duration: 1 min).
arm group label: Memory for naturalistic episodes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emiliano MACALUSO, PhD
role: Principal Investigator
affiliation: INSERM U1028 - Impact - CRNL
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided