<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/NCT03249857</url>
  </required_header>
  <id_info>
    <org_study_id>1708056</org_study_id>
    <secondary_id>2017-A00917-46</secondary_id>
    <nct_id>NCT03249857</nct_id>
  </id_info>
  <brief_title>Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.</brief_title>
  <official_title>Study of Sensorimotor Compatibility Effects in Bipolar Affective Disorder.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Based in an embodied approach of cognition, several studies have highlighted a direct link&#xD;
      between perception of an object or an emotion and the associated motor responses. This study&#xD;
      investigated in patients suffering from bipolar affective disorders whether the perception of&#xD;
      emotional words involves an automatic sensorimotor simulation of approach and avoidance&#xD;
      behaviors, and whether the perception of an object involves an automatic sensorimotor&#xD;
      simulation of object prehension (affordance). We hypothesize that, in this pathology, low&#xD;
      level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are&#xD;
      altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will&#xD;
      be recruited. The main objective is the emergence of sensorimotor compatibility effects in&#xD;
      approach-avoidance task with emotional stimuli (gain between compatible vs incompatible&#xD;
      conditions).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Actual">August 21, 2018</completion_date>
  <primary_completion_date type="Actual">August 21, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response time for avoidance and affordance task</measure>
    <time_frame>Months 24</time_frame>
    <description>Comparison of response time for avoidance and affordance task between patients and healthy volunteers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>response time for affordance task</measure>
    <time_frame>Months 24</time_frame>
    <description>Comparison of response time for affordance task between patients and healthy volunteers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms</measure>
    <time_frame>Months 24</time_frame>
    <description>These informations were collected of the medical file.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response time and cognitive tests</measure>
    <time_frame>Months 24</time_frame>
    <description>Correlation between response time and cognitive tests of patients and healthy volunteers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Bipolar Affective Disorder</condition>
  <arm_group>
    <arm_group_label>patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy volunteers (Control group) who will perform cognitive tasks + experimental task</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive tasks + IQ + MINI</intervention_name>
    <description>Patients will perform different tasks:&#xD;
cognitive tasks : reaction time (Alert TEA, Zimmermann and Fimm, 2005) + Edinburgh laterality questionnaire (Oldfield,1971) + hamilton and young's scale (Tohen et al., 2009) + Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) + experimental task (approach/ avoidance and affordance task).&#xD;
Intelligence Quotient (IQ) test (PM38, Raven, 1960)&#xD;
Mini International Neuropsychiatric Interview (MINI, Van Vliet et al., 2006)</description>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive tasks</intervention_name>
    <description>Healthy volunteers will perform only the cognitive tasks = reaction time alert TEA, Zimmermann and Fimm, 2005 + Edinburgh laterality questionnaire (Oldfield, 1971) + experimental task (approach/ avoidance and affordance task).</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For patients:&#xD;
&#xD;
          -  Affiliated or entitled to a social security&#xD;
&#xD;
          -  Aged between 18 and 55&#xD;
&#xD;
          -  Patients of both sexes suffering from bipolar disorders (DSM V criteria) whatever the&#xD;
             subtype&#xD;
&#xD;
          -  Stabilized from a point of view clinical and therapeutic&#xD;
&#xD;
          -  Euthymic (score &lt;7 at the Hamilton scale, and score &lt;8 at Young's scale)&#xD;
&#xD;
          -  Must have given their informed consent before their participation in the study&#xD;
&#xD;
          -  Be right-handed (score&gt; 14 on the laterality scale)&#xD;
&#xD;
        For control group:&#xD;
&#xD;
          -  Affiliated or entitled to a social security&#xD;
&#xD;
          -  Must have given their informed consent before their participation in the study&#xD;
&#xD;
          -  Be right-handed (score&gt; 14 on the lateral scale)&#xD;
&#xD;
          -  Aged 18 to 55 matched by age (± 5 years), sex, and on the study level of patients&#xD;
             (years of schooling after primary school ± 2 years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For patients:&#xD;
&#xD;
          -  Thymic acute decompensation&#xD;
&#xD;
          -  Hamilton scale &gt; 8, Young's scale &gt; 9&#xD;
&#xD;
          -  Montreal Cognitive Assessment (MOCA) &lt;26&#xD;
&#xD;
          -  History neurological pathology with cerebral impairment or serious somatic disease&#xD;
&#xD;
          -  Disorders related to the use of a psychoactive substance, as defined by the DSM-V&#xD;
             (abuse, dependence or withdrawal) within 6 months.&#xD;
&#xD;
          -  IQ &lt; 70&#xD;
&#xD;
          -  History of head trauma&#xD;
&#xD;
        For control group:&#xD;
&#xD;
          -  History of head trauma&#xD;
&#xD;
          -  Neurological pathology with cerebral impairment or serious somatic disease&#xD;
&#xD;
          -  Psychotropic treatment&#xD;
&#xD;
          -  Disorders related to the use of a psychoactive substance, as defined by the DSM-V&#xD;
             (abuse, dependence or withdrawal)&#xD;
&#xD;
          -  IQ &lt; 70&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine MASSOUBRE, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Saint-Etienne</name>
      <address>
        <city>St Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bipolar affective disorders</keyword>
  <keyword>Cognition</keyword>
  <keyword>Emotion</keyword>
  <keyword>Embodiment</keyword>
  <keyword>Sensorimotor</keyword>
  <keyword>Simulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genetic Diseases, X-Linked</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <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/NCT03249857
org study id: 1708056
secondary id: 2017-A00917-46
nct id: NCT03249857
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Based in an embodied approach of cognition, several studies have highlighted a direct link
      between perception of an object or an emotion and the associated motor responses. This study
      investigated in patients suffering from bipolar affective disorders whether the perception of
      emotional words involves an automatic sensorimotor simulation of approach and avoidance
      behaviors, and whether the perception of an object involves an automatic sensorimotor
      simulation of object prehension (affordance). We hypothesize that, in this pathology, low
      level (sensorimotor) cognitive processes are preserved whereas high-level (attentional) are
      altered. 20 patients suffering from bipolar affective disorders and 20 healthy controls will
      be recruited. The main objective is the emergence of sensorimotor compatibility effects in
      approach-avoidance task with emotional stimuli (gain between compatible vs incompatible
      conditions).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: response time for avoidance and affordance task
time frame: Months 24
description: Comparison of response time for avoidance and affordance task between patients and healthy volunteers.
measure: response time for affordance task
time frame: Months 24
description: Comparison of response time for affordance task between patients and healthy volunteers.
measure: correlations with age at onset of the disease, the number of thymic decompensations and the existence of psychotic symptoms
time frame: Months 24
description: These informations were collected of the medical file.
measure: response time and cognitive tests
time frame: Months 24
description: Correlation between response time and cognitive tests of patients and healthy volunteers.
arm group label: patients
arm group type: Experimental
description: Patients suffering bipolar affective disorders and who will perform cognitive tasks + IQ + MINI + experimental task
arm group label: control group
arm group type: Active Comparator
description: Healthy volunteers (Control group) who will perform cognitive tasks + experimental task
intervention type: Behavioral
intervention name: cognitive tasks + IQ + MINI
description: Patients will perform different tasks:
cognitive tasks : reaction time (Alert TEA, Zimmermann and Fimm, 2005) + Edinburgh laterality questionnaire (Oldfield,1971) + hamilton and young's scale (Tohen et al., 2009) + Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) + experimental task (approach/ avoidance and affordance task).
Intelligence Quotient (IQ) test (PM38, Raven, 1960)
Mini International Neuropsychiatric Interview (MINI, Van Vliet et al., 2006)
arm group label: patients
intervention type: Behavioral
intervention name: cognitive tasks
description: Healthy volunteers will perform only the cognitive tasks = reaction time alert TEA, Zimmermann and Fimm, 2005 + Edinburgh laterality questionnaire (Oldfield, 1971) + experimental task (approach/ avoidance and affordance task).
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Catherine MASSOUBRE, MD PhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
mesh term: Genetic Diseases, X-Linked
mesh term: Mood Disorders
mesh term: Bipolar Disorder
sharing ipd: No