<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/NCT02231645</url>
  </required_header>
  <id_info>
    <org_study_id>DBS-Parkinson</org_study_id>
    <nct_id>NCT02231645</nct_id>
  </id_info>
  <brief_title>Subthalamic Deep Brain Stimulation Effects on Decision-making Processing in Patients With Parkinson's Disease</brief_title>
  <official_title>Subthalamic Deep Brain Stimulation Effects on Moral and Economics Decision-making Processing in Patients With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Istituto Neurologico Nazionale IRCCS Casimiro Mondino, Pavia, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether subthalamic deep brain stimulation (STN DBS)&#xD;
      can affect moral and economic decisions in patients with Parkinson's disease (PD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sample&#xD;
&#xD;
      A group of patients with idiopathic PD and with bilateral STN DBS implant (experimental&#xD;
      group) and a control group including patients with idiopathic PD and without DBS implant who&#xD;
      are treated with dopaminergic medications will be recruited from the IRCCS Fondazione Ca'&#xD;
      Granda Ospedale Maggiore Policlinico of Milan and from the Istituto Neurologico Nazionale&#xD;
      IRCCS Casimiro Mondino of Pavia. Patients will be selected in order to balance groups for&#xD;
      gender, age, disease duration, cognitive and motor functions.&#xD;
&#xD;
      Decision-making computerized tasks&#xD;
&#xD;
      Moral task. The task consisted of 38 sentences divided into 13 neutral, 10 moral conflictual&#xD;
      and 15 moral non conflictual statements. Each statement was presented in a random order for a&#xD;
      maximum of 10 s. During this period, participants were instructed to read each sentence and&#xD;
      to respond if they agreed or disagreed with it by pressing the &quot;A&quot; (agreement) or the &quot;L&quot;&#xD;
      (disagreement) keys with the left or the right finger. After the key was pressed, a black&#xD;
      screen was displayed for 1 s before the next statement appeared on the screen (Fumagalli et&#xD;
      al., 2011).&#xD;
&#xD;
      Economics task. Pairs of stimuli (four letters from the Latin alphabet) are presented on the&#xD;
      screen in white on a black background. To maximize gains, subjects are asked to choose a&#xD;
      letter by pressing one of the two keyboard keys, corresponding to the stimulus on the left or&#xD;
      right of the screen. Each choice prompts two visual feedbacks, the first displaying the money&#xD;
      won or lost and the second indicating the total sum of money the subject was gaining. Each&#xD;
      stimulus pair is preceded by a black screen. Six different stimulus pairs (AB, AC, AD, BC,&#xD;
      BD, CD) are presented. Stimulus pairs comprised stimuli with the same probability to win&#xD;
      (conflictual trials) and different probability to win (non conflictual trials). The letters&#xD;
      &quot;A&quot; and &quot;D&quot; led to positive feedback (+60 Euros) 80% of the times and to negative feedback&#xD;
      (-30 Euros) 20% of the times (non risky letters). &quot;B&quot; and &quot;C&quot; letters led to high positive&#xD;
      feedback (+100 Euros) only 20% of the times and to a high negative feedback (-70 Euros) 80%&#xD;
      (risky letters). The task is designed to reward non risky choices, so that the larger the&#xD;
      number of non risky choices, the higher is the amount of money earned. The task comprises 102&#xD;
      trials, 68 non conflictual and 34 conflictual (Rosa et al., 2013).&#xD;
&#xD;
      Experimental protocol&#xD;
&#xD;
      All patients will be tested with the moral and the economics tasks during the best ON-drug&#xD;
      medication condition. The experimental group performed the tasks in the STN DBS ON condition&#xD;
      and in the STN DBS OFF condition. Following the end of the STN DBS ON session, the DBS&#xD;
      devices will be turned off by the physician 30 minutes prior to the STN DBS OFF session. The&#xD;
      order of stimulation conditions and of the versions of the task will be randomized and&#xD;
      counterbalanced.&#xD;
&#xD;
      The control group will similarly perform the moral and the economics tasks twice with the&#xD;
      same time intervals, without the STN DBS manipulation.&#xD;
&#xD;
      Motor, cognitive and psychological assessment. Patients will perform a short motor, cognitive&#xD;
      and psychological assessment using the UPDRS III, the MMSE and VASs for subjective evaluation&#xD;
      of mood, anxiety, movement difficulty and motor fatigue. VASs will be performed twice: in STN&#xD;
      DBS ON and OFF conditions for experimental group, and in the first and the second session for&#xD;
      the control group. UPDRS III and MMSE will be evaluated when patients from the experimental&#xD;
      group are in STN DBS ON condition and when control patients are in the first session.&#xD;
&#xD;
      Statistical Analysis&#xD;
&#xD;
      Normality tests will be performed on behavioural data (reaction times and responses at&#xD;
      computerized tasks, scores obtained at MMSE, UPDRS III, VASs) with One-Sample&#xD;
      Kolmogorov-Smirnov Test.&#xD;
&#xD;
      Behavioural data obtained by the experimental group in STN DBS ON and STN DBS OFF conditions&#xD;
      will be compared with analysis of variance (ANOVA). Also data obtained by patients from the&#xD;
      experimental group will be compared to data obtained by the control groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reaction times and responses recorded at the moral task</measure>
    <time_frame>For the experimental group these measures are collected in ON and OFF STN DBS (30 minutes pass between the ON and OFF condition)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reaction times and responses recorded at the economics task</measure>
    <time_frame>For the experimental group these measures are collected in ON and OFF STN DBS (30 minutes pass between the ON and OFF condition)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>STN DBS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental protocol is executed in PD patients with STN DBS implant in STN DBS ON and OFF conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Experimental protocol is executed in PD patients without STN DBS implant twice without experimental variable manipulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>STN DBS</intervention_name>
    <description>The DBS device is turned on and off by the physician.</description>
    <arm_group_label>STN DBS group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease&#xD;
&#xD;
          -  For experimental group: STN DBS implant occurred no less than 6 months before and with&#xD;
             optimal stimulation parameters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive, behavioural and psychiatric symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alberto Priori, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano</affiliation>
  </overall_official>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>Deep brain stimulation</keyword>
  <keyword>Subthalamic nucleus</keyword>
  <keyword>decision-making</keyword>
  <keyword>cognition</keyword>
  <keyword>behavior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT02231645
org study id: DBS-Parkinson
nct id: NCT02231645
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate whether subthalamic deep brain stimulation (STN DBS)
      can affect moral and economic decisions in patients with Parkinson's disease (PD).
Sample

      A group of patients with idiopathic PD and with bilateral STN DBS implant (experimental
      group) and a control group including patients with idiopathic PD and without DBS implant who
      are treated with dopaminergic medications will be recruited from the IRCCS Fondazione Ca'
      Granda Ospedale Maggiore Policlinico of Milan and from the Istituto Neurologico Nazionale
      IRCCS Casimiro Mondino of Pavia. Patients will be selected in order to balance groups for
      gender, age, disease duration, cognitive and motor functions.

      Decision-making computerized tasks

      Moral task. The task consisted of 38 sentences divided into 13 neutral, 10 moral conflictual
      and 15 moral non conflictual statements. Each statement was presented in a random order for a
      maximum of 10 s. During this period, participants were instructed to read each sentence and
      to respond if they agreed or disagreed with it by pressing the "A" (agreement) or the "L"
      (disagreement) keys with the left or the right finger. After the key was pressed, a black
      screen was displayed for 1 s before the next statement appeared on the screen (Fumagalli et
      al., 2011).

      Economics task. Pairs of stimuli (four letters from the Latin alphabet) are presented on the
      screen in white on a black background. To maximize gains, subjects are asked to choose a
      letter by pressing one of the two keyboard keys, corresponding to the stimulus on the left or
      right of the screen. Each choice prompts two visual feedbacks, the first displaying the money
      won or lost and the second indicating the total sum of money the subject was gaining. Each
      stimulus pair is preceded by a black screen. Six different stimulus pairs (AB, AC, AD, BC,
      BD, CD) are presented. Stimulus pairs comprised stimuli with the same probability to win
      (conflictual trials) and different probability to win (non conflictual trials). The letters
      "A" and "D" led to positive feedback (+60 Euros) 80% of the times and to negative feedback
      (-30 Euros) 20% of the times (non risky letters). "B" and "C" letters led to high positive
      feedback (+100 Euros) only 20% of the times and to a high negative feedback (-70 Euros) 80%
      (risky letters). The task is designed to reward non risky choices, so that the larger the
      number of non risky choices, the higher is the amount of money earned. The task comprises 102
      trials, 68 non conflictual and 34 conflictual (Rosa et al., 2013).

      Experimental protocol

      All patients will be tested with the moral and the economics tasks during the best ON-drug
      medication condition. The experimental group performed the tasks in the STN DBS ON condition
      and in the STN DBS OFF condition. Following the end of the STN DBS ON session, the DBS
      devices will be turned off by the physician 30 minutes prior to the STN DBS OFF session. The
      order of stimulation conditions and of the versions of the task will be randomized and
      counterbalanced.

      The control group will similarly perform the moral and the economics tasks twice with the
      same time intervals, without the STN DBS manipulation.

      Motor, cognitive and psychological assessment. Patients will perform a short motor, cognitive
      and psychological assessment using the UPDRS III, the MMSE and VASs for subjective evaluation
      of mood, anxiety, movement difficulty and motor fatigue. VASs will be performed twice: in STN
      DBS ON and OFF conditions for experimental group, and in the first and the second session for
      the control group. UPDRS III and MMSE will be evaluated when patients from the experimental
      group are in STN DBS ON condition and when control patients are in the first session.

      Statistical Analysis

      Normality tests will be performed on behavioural data (reaction times and responses at
      computerized tasks, scores obtained at MMSE, UPDRS III, VASs) with One-Sample
      Kolmogorov-Smirnov Test.

      Behavioural data obtained by the experimental group in STN DBS ON and STN DBS OFF conditions
      will be compared with analysis of variance (ANOVA). Also data obtained by patients from the
      experimental group will be compared to data obtained by the control groups.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Reaction times and responses recorded at the moral task
time frame: For the experimental group these measures are collected in ON and OFF STN DBS (30 minutes pass between the ON and OFF condition)
measure: Reaction times and responses recorded at the economics task
time frame: For the experimental group these measures are collected in ON and OFF STN DBS (30 minutes pass between the ON and OFF condition)
arm group label: STN DBS group
arm group type: Experimental
description: Experimental protocol is executed in PD patients with STN DBS implant in STN DBS ON and OFF conditions
arm group label: Control group
arm group type: No Intervention
description: Experimental protocol is executed in PD patients without STN DBS implant twice without experimental variable manipulation.
intervention type: Device
intervention name: STN DBS
description: The DBS device is turned on and off by the physician.
arm group label: STN DBS group
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Alberto Priori, MD, PhD
role: Study Director
affiliation: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
responsible party type: Sponsor
mesh term: Parkinson Disease