<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/NCT03004573</url>
  </required_header>
  <id_info>
    <org_study_id>69 HCL15_0760</org_study_id>
    <secondary_id>2016-A00143-48</secondary_id>
    <nct_id>NCT03004573</nct_id>
  </id_info>
  <brief_title>Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients</brief_title>
  <official_title>Functioning of the Mirror Neurons System in Parkinson's Disease and Its Impact on the Social Cognition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs&#xD;
      with a major impact on the quality of life. Social cognition is a complex system relying on&#xD;
      emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts:&#xD;
      emotional and cognitive), but also on the social and cultural environment and the personal&#xD;
      history. The first step in this model is represented by the NMS, which seems to be altered in&#xD;
      PD patients for both positive and negative emotions as shown in our preliminary study. The&#xD;
      investigator purpose is to investigate the role of the treatment (levodopa and deep brain&#xD;
      stimulation) on the functioning of the NMS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2017</start_date>
  <completion_date type="Actual">December 13, 2019</completion_date>
  <primary_completion_date type="Actual">December 13, 2019</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>variation of the emotional recognition score (point lights test) before deep brain surgery</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>variation of the emotional recognition score (point lights test) after deep brain surgery</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PDQ39 score (Parkinson's Disease Questionnaire)</measure>
    <time_frame>1 year</time_frame>
    <description>Quality of Life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MATTIS (dementia rating scale) score</measure>
    <time_frame>1 year</time_frame>
    <description>Global cognition. The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Deep brain stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neuropsychological detailed tests with focus on social cognition</intervention_name>
    <description>MATTIS, MOCA, BREF, Light points test, PDQ39</description>
    <arm_group_label>Deep brain stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain&#xD;
             stimulation&#xD;
&#xD;
          -  Social insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No affiliation to the social insurance&#xD;
&#xD;
          -  Patients under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teodor Danaila, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Neurologie C Hôpital &quot; Pierre Wertheimer &quot;</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson Disease</keyword>
  <keyword>emotional recognition</keyword>
  <keyword>Deep Brain Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03004573
org study id: 69 HCL15_0760
secondary id: 2016-A00143-48
nct id: NCT03004573
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs
      with a major impact on the quality of life. Social cognition is a complex system relying on
      emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts:
      emotional and cognitive), but also on the social and cultural environment and the personal
      history. The first step in this model is represented by the NMS, which seems to be altered in
      PD patients for both positive and negative emotions as shown in our preliminary study. The
      investigator purpose is to investigate the role of the treatment (levodopa and deep brain
      stimulation) on the functioning of the NMS.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: variation of the emotional recognition score (point lights test) before deep brain surgery
time frame: Baseline
measure: variation of the emotional recognition score (point lights test) after deep brain surgery
time frame: 1 year
measure: PDQ39 score (Parkinson's Disease Questionnaire)
time frame: 1 year
description: Quality of Life
measure: MATTIS (dementia rating scale) score
time frame: 1 year
description: Global cognition. The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia
arm group label: Deep brain stimulation
arm group type: Experimental
intervention type: Other
intervention name: Neuropsychological detailed tests with focus on social cognition
description: MATTIS, MOCA, BREF, Light points test, PDQ39
arm group label: Deep brain stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Teodor Danaila, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No