<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/NCT03753230</url>
  </required_header>
  <id_info>
    <org_study_id>API/2018/92</org_study_id>
    <nct_id>NCT03753230</nct_id>
  </id_info>
  <brief_title>Clinical Qualification Study of Electroencephalographic Mobile Equipment for the Capture of Emotions</brief_title>
  <acronym>QUAdEMCE</acronym>
  <official_title>Clinical Qualification Study of Electroencephalographic Mobile Equipment for the Capture of Emotions</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 determine the reliability of various EEG wireless headsets. Their signal&#xD;
      will be compared to standard high-density EEG recording during music listening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">September 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality and spatial/temporal coherence in oscillatory responses patterns recorded with EEG wireless headsets (Emotiv and g.tec) and with the EEG high density gold standard</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>Brain activity will be recorded continuously during musical extract listening. The coherence of EEG activity between the three different devices on similar electrodes will be measured and compared for several brainwaves (delta, theta, alpha, beta, gamma)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Musical Emotions</condition>
  <arm_group>
    <arm_group_label>EEG Device 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are listening to music while their neural activity is recorded with Emotiv Epoc+</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EEG Device 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are listening to music while their neural activity is recorded with g.tec</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High density EEG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are listening to music while their neural activity is recorded with high density 256 electrodes EEG Geodesic</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electroencephalography</intervention_name>
    <description>Cerebral measurements from electroencephalography devices while music is presented to the participant</description>
    <arm_group_label>EEG Device 1</arm_group_label>
    <arm_group_label>EEG Device 2</arm_group_label>
    <arm_group_label>High density EEG</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;
          -  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>
  <overall_contact>
    <last_name>Lionel PAZART, MD, PhD, MPH</last_name>
    <phone>+33 381 218 622</phone>
    <email>lpazart@chu-besancon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Damien GABRIEL, PhD</last_name>
    <phone>+33 381 219 148</phone>
    <email>dgabriel@chu-besancon.fr</email>
  </overall_contact_backup>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 23, 2018</last_update_submitted>
  <last_update_submitted_qc>November 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</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/NCT03753230
org study id: API/2018/92
nct id: NCT03753230
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aim to determine the reliability of various EEG wireless headsets. Their signal
      will be compared to standard high-density EEG recording during music listening.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Quality and spatial/temporal coherence in oscillatory responses patterns recorded with EEG wireless headsets (Emotiv and g.tec) and with the EEG high density gold standard
time frame: Up to 2 weeks
description: Brain activity will be recorded continuously during musical extract listening. The coherence of EEG activity between the three different devices on similar electrodes will be measured and compared for several brainwaves (delta, theta, alpha, beta, gamma)
arm group label: EEG Device 1
arm group type: Experimental
description: Participants are listening to music while their neural activity is recorded with Emotiv Epoc+
arm group label: EEG Device 2
arm group type: Experimental
description: Participants are listening to music while their neural activity is recorded with g.tec
arm group label: High density EEG
arm group type: Active Comparator
description: Participants are listening to music while their neural activity is recorded with high density 256 electrodes EEG Geodesic
intervention type: Device
intervention name: Electroencephalography
description: Cerebral measurements from electroencephalography devices while music is presented to the participant
arm group label: EEG Device 1
arm group label: EEG Device 2
arm group label: High density EEG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lionel PAZART, MD, PhD, MPH
phone: +33 381 218 622
email: lpazart@chu-besancon.fr
last name: Damien GABRIEL, PhD
phone: +33 381 219 148
email: dgabriel@chu-besancon.fr
responsible party type: Sponsor