<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/NCT03753620</url>
  </required_header>
  <id_info>
    <org_study_id>API/2017/91</org_study_id>
    <nct_id>NCT03753620</nct_id>
  </id_info>
  <brief_title>Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity</brief_title>
  <acronym>NEUREXPLO</acronym>
  <official_title>Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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 study aim to improve the quality of EEG recordings during simultaneous fMRI acquisitions.&#xD;
      The second aim is to validate the correspondence between cerebral areas activated in fMRI and&#xD;
      cortical areas identified with high density EEG during the listening of emotional musical&#xD;
      pieces.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2019</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 27, 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between synchronous cerebral hemodynamics and electric patterns recorded with both EEG and fMRI simultaneously during the production of musical emotions.</measure>
    <time_frame>Day 0</time_frame>
    <description>The cerebral activity will be measured continuously during musical extracts listening and comparison of the participant self report emotional level will allow to compare fMRI and EEG data to ensure a good correspondence.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Music Listening</condition>
  <arm_group>
    <arm_group_label>Music listening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants listens to their favorite emotional musical extracts. While listening, their Hemodynamic activity (with fMRI), their cerebral electric activity (with EEG) and their peripheral physiological parameters are recorded simultaneously</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>simultaneous fMRI and EEG + peripheral measures</intervention_name>
    <description>Hemodynamic activity recorded with fMRI, cerebral electric activity recorded with EEG as well as peripheral physiological parameters will be recorded during music listening.</description>
    <arm_group_label>Music listening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EEG and peripheral measures</intervention_name>
    <description>cerebral electric( with EEG) as well as peripheral physiological parameters will be recorded during music listening.</description>
    <arm_group_label>Music listening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Right handed healthy people&#xD;
&#xD;
          -  Sensitive to &quot;music chill&quot; (Barcelona Reward music Questionnaire&gt;50)&#xD;
&#xD;
          -  Having given their participation agreement&#xD;
&#xD;
          -  Individual with health insurance coverage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Individuals in &quot;exclusion period&quot; of another study&#xD;
&#xD;
          -  No inclusion criteria of fMRI acquisition&#xD;
&#xD;
          -  Subjects with auditory deficits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>June 20, 2022</last_update_submitted>
  <last_update_submitted_qc>June 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03753620
org study id: API/2017/91
nct id: NCT03753620
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aim to improve the quality of EEG recordings during simultaneous fMRI acquisitions.
      The second aim is to validate the correspondence between cerebral areas activated in fMRI and
      cortical areas identified with high density EEG during the listening of emotional musical
      pieces.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Correlation between synchronous cerebral hemodynamics and electric patterns recorded with both EEG and fMRI simultaneously during the production of musical emotions.
time frame: Day 0
description: The cerebral activity will be measured continuously during musical extracts listening and comparison of the participant self report emotional level will allow to compare fMRI and EEG data to ensure a good correspondence.
arm group label: Music listening
arm group type: Experimental
description: The participants listens to their favorite emotional musical extracts. While listening, their Hemodynamic activity (with fMRI), their cerebral electric activity (with EEG) and their peripheral physiological parameters are recorded simultaneously
intervention type: Device
intervention name: simultaneous fMRI and EEG + peripheral measures
description: Hemodynamic activity recorded with fMRI, cerebral electric activity recorded with EEG as well as peripheral physiological parameters will be recorded during music listening.
arm group label: Music listening
intervention type: Device
intervention name: EEG and peripheral measures
description: cerebral electric( with EEG) as well as peripheral physiological parameters will be recorded during music listening.
arm group label: Music listening
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor