<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/NCT04406675</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01213-36</org_study_id>
    <nct_id>NCT04406675</nct_id>
  </id_info>
  <brief_title>Social Cognition in Patients With Amyotrophic Lateral Sclerosis</brief_title>
  <acronym>COSISLA</acronym>
  <official_title>Social Cognition in Patients With Amyotrophic Lateral Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease&#xD;
      evidenced by gradual paralysis of the muscles involved in voluntary motor function. The&#xD;
      clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower&#xD;
      motor neuron signs and symptoms. The most recent studies suggest that up to 50% of&#xD;
      Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance.&#xD;
      Impaired social cognition, including a deficit in the recognition of facial emotions and the&#xD;
      identification of vocal prosody, is recognized as a part of the cognitive phenotype of&#xD;
      Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers'&#xD;
      training. However, studies remain scarce and the data acquired must be supported. The&#xD;
      evolution of these manifestations during the disease is still poorly understood.&#xD;
&#xD;
      In this study the investigators aim to assess the social cognition capacities of patients&#xD;
      with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the social cognition capacities</measure>
    <time_frame>One day</time_frame>
    <description>Evaluate the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to control subjects using dynamic social cognition tests : Movie for the Assessment of Social Cognition. The maximum score is 48 points. The higher the score for correct answers, the better the performance.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Social Cognition</condition>
  <arm_group>
    <arm_group_label>Patients Amyotrophic Lateral Sclerosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>neuropsychological test</intervention_name>
    <description>neuropsychological test</description>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_label>Patients Amyotrophic Lateral Sclerosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient Amyotrophic Lateral Sclerosis :&#xD;
&#xD;
          -  Education of at least 7 years&#xD;
&#xD;
          -  Native language: French&#xD;
&#xD;
          -  Patients Amyotrophic Lateral Sclerosis&#xD;
&#xD;
          -  Signature of informed consent to participate in the study&#xD;
&#xD;
          -  Accompanied patient&#xD;
&#xD;
        Control subject :&#xD;
&#xD;
          -  People without any pathology&#xD;
&#xD;
          -  Education of at least 7 years&#xD;
&#xD;
          -  Native language: French&#xD;
&#xD;
          -  Signature of informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient Amyotrophic Lateral Sclerosis and control subject :&#xD;
&#xD;
          -  Simultaneous participation in another interventional protocol with experimental&#xD;
             treatment&#xD;
&#xD;
          -  Inability to perform cognitive study tests&#xD;
&#xD;
          -  Pregnant, lactating or parturient women&#xD;
&#xD;
          -  Persons deprived of their liberty by administrative or judicial decision&#xD;
&#xD;
          -  Persons under psychiatric care under duress&#xD;
&#xD;
          -  Persons subject to legal protection measures&#xD;
&#xD;
          -  Persons out of state to express their consent&#xD;
&#xD;
          -  People not affiliated or not beneficiaries of a social security scheme&#xD;
&#xD;
          -  History likely to disturb cognition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Cassereau Julien</last_name>
    <phone>0241355615</phone>
    <email>jucassereau@chu-angers.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Muller Jeanne</last_name>
    <email>jeanne.muller@chu-angers.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Muller Jeanne</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04406675
org study id: 2020-A01213-36
nct id: NCT04406675
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease
      evidenced by gradual paralysis of the muscles involved in voluntary motor function. The
      clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower
      motor neuron signs and symptoms. The most recent studies suggest that up to 50% of
      Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance.
      Impaired social cognition, including a deficit in the recognition of facial emotions and the
      identification of vocal prosody, is recognized as a part of the cognitive phenotype of
      Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers'
      training. However, studies remain scarce and the data acquired must be supported. The
      evolution of these manifestations during the disease is still poorly understood.

      In this study the investigators aim to assess the social cognition capacities of patients
      with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Evaluate the social cognition capacities
time frame: One day
description: Evaluate the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to control subjects using dynamic social cognition tests : Movie for the Assessment of Social Cognition. The maximum score is 48 points. The higher the score for correct answers, the better the performance.
arm group label: Patients Amyotrophic Lateral Sclerosis
arm group type: Other
arm group label: Control subjects
arm group type: Other
intervention type: Other
intervention name: neuropsychological test
description: neuropsychological test
arm group label: Control subjects
arm group label: Patients Amyotrophic Lateral Sclerosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cassereau Julien
phone: 0241355615
email: jucassereau@chu-angers.fr
last name: Muller Jeanne
email: jeanne.muller@chu-angers.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis