<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/NCT03243370</url>
  </required_header>
  <id_info>
    <org_study_id>GROS-GIROUD-2014</org_study_id>
    <nct_id>NCT03243370</nct_id>
  </id_info>
  <brief_title>Clock'N' Test: Development and Validation of a Test to Evaluate Emotional Disorders</brief_title>
  <acronym>Clock'N'test</acronym>
  <official_title>Clock'N' Test: Development and Validation (in a Control Population) of a Test Based on Time Estimations and Aiming to Evaluate Emotional Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      This study concerns the validation of a clinical test that aims to reveal &quot;first level&quot;&#xD;
      emotional disorders in neurological diseases.&#xD;
&#xD;
      In order to bring to light such disorders, it is necessary to begin by establishing reference&#xD;
      values in healthy individuals. This test is based on the priming effect and time estimations.&#xD;
      The test procedure has two successive phases. The first phase aims to determine the judgement&#xD;
      of time inherent to each participant and then to assess whether or not this judgement varies&#xD;
      during the second phase with the introduction of emotional priming. First, we set out to look&#xD;
      for and to calibrate video stimuli able to activate emotions. To this end, we used a battery&#xD;
      of 70 sequences developed recently by Schaefer, Nils, Sanchez and Philippot. We determined&#xD;
      their degree of physiological activation by measuring the electrodermal response at the&#xD;
      laboratory for the exploration of the nervous system in Dijon. These measurements also&#xD;
      allowed us to define and refine our paradigm, notably by deciding at what moment the time&#xD;
      estimation task should be done and by eliminating the influence of attention. We decided to&#xD;
      select only seven video sequences because we noticed a reduction in the measurement effect on&#xD;
      time estimations due to habituation of the subject. We also conducted pre-tests in a control&#xD;
      population made up of twenty men and women aged from 20 to 60 years.&#xD;
&#xD;
      This brought to light a warp in time estimation opposite to that we found using olfactory&#xD;
      stimuli. This first finding suggests that there are two types of emotion, one which is&#xD;
      anticipative and the other immediately experienced.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Score obtained in the Clock n'test: [time estimation with priming]-[time estimation without priming].</measure>
    <time_frame>1 day</time_frame>
    <description>Bring to light &quot;first-level&quot; emotional disorders. It is based on the priming effect of time estimation</description>
  </primary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>Healthy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This test is based on the priming effect and time estimations. The test procedure has two&#xD;
        successive phases. The first phase aims to determine the judgement of time inherent to each&#xD;
        participant and then to assess whether or not this judgement varies during the second phase&#xD;
        with the introduction of emotional priming.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  persons who have given their consent to participate&#xD;
&#xD;
          -  aged between 20 and 92 years.&#xD;
&#xD;
          -  persons who understand and speak French.&#xD;
&#xD;
          -  persons informed about the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  persons without national health insurance cover&#xD;
&#xD;
          -  disease likely to cause emotional disorders (history of paralimbic brain tumour, MS,&#xD;
             Parkinson, history of depression, bipolar disorder…).&#xD;
&#xD;
          -  heart disease, spasmophilia.&#xD;
&#xD;
          -  cognitive disorders likely to interfere with understanding the instructions.&#xD;
&#xD;
          -  visual or auditory, sensory or motor disorders.&#xD;
&#xD;
          -  refusal to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>92 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu de Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Validate the Clock'nTest</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03243370
org study id: GROS-GIROUD-2014
nct id: NCT03243370
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study concerns the validation of a clinical test that aims to reveal "first level"
      emotional disorders in neurological diseases.

      In order to bring to light such disorders, it is necessary to begin by establishing reference
      values in healthy individuals. This test is based on the priming effect and time estimations.
      The test procedure has two successive phases. The first phase aims to determine the judgement
      of time inherent to each participant and then to assess whether or not this judgement varies
      during the second phase with the introduction of emotional priming. First, we set out to look
      for and to calibrate video stimuli able to activate emotions. To this end, we used a battery
      of 70 sequences developed recently by Schaefer, Nils, Sanchez and Philippot. We determined
      their degree of physiological activation by measuring the electrodermal response at the
      laboratory for the exploration of the nervous system in Dijon. These measurements also
      allowed us to define and refine our paradigm, notably by deciding at what moment the time
      estimation task should be done and by eliminating the influence of attention. We decided to
      select only seven video sequences because we noticed a reduction in the measurement effect on
      time estimations due to habituation of the subject. We also conducted pre-tests in a control
      population made up of twenty men and women aged from 20 to 60 years.

      This brought to light a warp in time estimation opposite to that we found using olfactory
      stimuli. This first finding suggests that there are two types of emotion, one which is
      anticipative and the other immediately experienced.
observational model: Cohort
time perspective: Prospective
measure: Score obtained in the Clock n'test: [time estimation with priming]-[time estimation without priming].
time frame: 1 day
description: Bring to light "first-level" emotional disorders. It is based on the priming effect of time estimation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 92 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No