<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/NCT03793491</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/18/0390</org_study_id>
    <nct_id>NCT03793491</nct_id>
  </id_info>
  <brief_title>Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs, in Parkinson's Disease</brief_title>
  <acronym>PSYCHO-PERF</acronym>
  <official_title>Study About Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs (by Subcutaneous Apomorphine Infusion or Intrajejunal Infusion of Levodopa-carbidopa), in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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 aim of the study is to evaluate if patients' personality could be considerate as&#xD;
      predictive factor of quality of life after the establishment of continuous infusion of&#xD;
      dopaminergic treatments to observe if there are predictive personality's profiles of specific&#xD;
      therapeutic response (Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) or&#xD;
      continuous infusion).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's disease leads to quality of life degradation, especially at level of motor&#xD;
      complications. Second line treatment can be proposed to patients. There are deep brain&#xD;
      stimulation and two treatments by continuous perfusion: subcutaneous apomorphine infusion and&#xD;
      intrajejunal infusion of levodopa-carbidopa. These treatments allow improvement of&#xD;
      end-of-dose akinesia, dyskinesia, and a diminution of treatments per os. Nonetheless, they&#xD;
      also lead to some side effects and complications. Currently, there are no scientific data to&#xD;
      compare the efficacy of these two techniques on motor and non-motor symptoms. Choice is made&#xD;
      according to the profile of the patient mainly based on side effects risks, and&#xD;
      practitioner's habits. There are still no predictive factors clearly defined to judge of the&#xD;
      best efficacy of these treatments according to the patients. Moreover, in an additional study&#xD;
      named PSYCHO-STIM, the investigator have discovered that personality can be a predictive&#xD;
      factor of quality of life amelioration 1 year after deep brain stimulation. It's why the&#xD;
      investigator would like to test personality as a predictive factor of therapeutic response&#xD;
      after both continuous perfusions that are available for the patients. Thus, patients&#xD;
      beginning a treatment by subcutaneous apomorphine infusion or intrajejunal infusion of&#xD;
      levodopa-carbidopa will be included. The investigator will evaluate their personality with&#xD;
      the questionnaire &quot;TCI&quot; (Temperament and Character Inventory) and the investigator will&#xD;
      assess their quality of life (PDQ-39), looking for the percentage of amelioration 6 months&#xD;
      after the treatment by continuous infusion started. As secondary criteria, depression (HAMD),&#xD;
      anxiety (HAMA), apathy (LARS), motility (MDS-UPDRS) and clinic severity (CGIS) will also be&#xD;
      accessed before the treatment change and six months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Anticipated">June 18, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 18, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>percent of improvement of quality of life score at 6 months after the beginning of the second line treatment</measure>
    <time_frame>day 1</time_frame>
    <description>Evaluation of life quality using Parkinson's Disease Questionnaire (PDQ-39) scale before (day 1) and after (6 month) the starting of perfusion treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percent of improvement of quality of life score at 6 months after the beginning of the second line treatment</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of life quality using PDQ-39 scale before and after the starting of perfusion treatment</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Patients having Parkinson's disease</arm_group_label>
    <description>Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease. Patients will have TCI scale and PDQ-39 scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TCI scale</intervention_name>
    <description>TCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started.</description>
    <arm_group_label>Patients having Parkinson's disease</arm_group_label>
    <other_name>Temperament and Character Inventory scale (TCI)</other_name>
    <other_name>Quality of life scale</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PDQ-39 scale</intervention_name>
    <description>PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion.</description>
    <arm_group_label>Patients having Parkinson's disease</arm_group_label>
    <other_name>Parkinson's Disease Questionnaire (PDQ-39)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parkinson patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having Parkinson's disease according to United Kingdom Parkinson's Disease&#xD;
             Society Brain Bank (UKPDSBB) criteria&#xD;
&#xD;
          -  All Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and&#xD;
             in need of the establishment of a second line treatment by subcutaneous apomorphine&#xD;
             infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical&#xD;
             care of their Parkinson's disease&#xD;
&#xD;
          -  Patient able to give its free and informed consent&#xD;
&#xD;
          -  Patient having a social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients presenting atypical Parkinson's syndrome&#xD;
&#xD;
          -  Patients having a deep brain stimulation&#xD;
&#xD;
          -  Patient having a psychiatric disease such as: mood disorders, psychotic disorder…&#xD;
&#xD;
          -  Patients presenting a cognitive decline evaluated by a Montreal Cognitive Assessment&#xD;
             (MoCA) score inferior to 24&#xD;
&#xD;
          -  None ability to give its consent&#xD;
&#xD;
          -  Patients unable to realize the tests provided in the context of this study&#xD;
&#xD;
          -  Patients under supervision, curators, or legal guardian&#xD;
&#xD;
          -  Patients non-affiliated to a social security&#xD;
&#xD;
          -  Patients in exclusion period of another study.&#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>Chrisitine BREFEL COURBON, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UHToulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>continuous infusion</keyword>
  <keyword>personality</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/NCT03793491
org study id: RC31/18/0390
nct id: NCT03793491
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate if patients' personality could be considerate as
      predictive factor of quality of life after the establishment of continuous infusion of
      dopaminergic treatments to observe if there are predictive personality's profiles of specific
      therapeutic response (Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) or
      continuous infusion).
Parkinson's disease leads to quality of life degradation, especially at level of motor
      complications. Second line treatment can be proposed to patients. There are deep brain
      stimulation and two treatments by continuous perfusion: subcutaneous apomorphine infusion and
      intrajejunal infusion of levodopa-carbidopa. These treatments allow improvement of
      end-of-dose akinesia, dyskinesia, and a diminution of treatments per os. Nonetheless, they
      also lead to some side effects and complications. Currently, there are no scientific data to
      compare the efficacy of these two techniques on motor and non-motor symptoms. Choice is made
      according to the profile of the patient mainly based on side effects risks, and
      practitioner's habits. There are still no predictive factors clearly defined to judge of the
      best efficacy of these treatments according to the patients. Moreover, in an additional study
      named PSYCHO-STIM, the investigator have discovered that personality can be a predictive
      factor of quality of life amelioration 1 year after deep brain stimulation. It's why the
      investigator would like to test personality as a predictive factor of therapeutic response
      after both continuous perfusions that are available for the patients. Thus, patients
      beginning a treatment by subcutaneous apomorphine infusion or intrajejunal infusion of
      levodopa-carbidopa will be included. The investigator will evaluate their personality with
      the questionnaire "TCI" (Temperament and Character Inventory) and the investigator will
      assess their quality of life (PDQ-39), looking for the percentage of amelioration 6 months
      after the treatment by continuous infusion started. As secondary criteria, depression (HAMD),
      anxiety (HAMA), apathy (LARS), motility (MDS-UPDRS) and clinic severity (CGIS) will also be
      accessed before the treatment change and six months later.
observational model: Case-Only
time perspective: Prospective
measure: percent of improvement of quality of life score at 6 months after the beginning of the second line treatment
time frame: day 1
description: Evaluation of life quality using Parkinson's Disease Questionnaire (PDQ-39) scale before (day 1) and after (6 month) the starting of perfusion treatment
measure: percent of improvement of quality of life score at 6 months after the beginning of the second line treatment
time frame: 6 months
description: Evaluation of life quality using PDQ-39 scale before and after the starting of perfusion treatment
arm group label: Patients having Parkinson's disease
description: Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease. Patients will have TCI scale and PDQ-39 scale.
intervention type: Other
intervention name: TCI scale
description: TCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started.
arm group label: Patients having Parkinson's disease
other name: Temperament and Character Inventory scale (TCI)
other name: Quality of life scale
intervention type: Other
intervention name: PDQ-39 scale
description: PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion.
arm group label: Patients having Parkinson's disease
other name: Parkinson's Disease Questionnaire (PDQ-39)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chrisitine BREFEL COURBON, PH
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No