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Subthalamic Deep Brain Stimulation Effects on Decision-making Processing in Patients With Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
STN DBS
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Parkinson's disease, Deep brain stimulation, Subthalamic nucleus, decision-making, cognition, behavior

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parkinson's disease
  • For experimental group: STN DBS implant occurred no less than 6 months before and with optimal stimulation parameters

Exclusion Criteria:

  • Cognitive, behavioural and psychiatric symptoms

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    STN DBS group

    Control group

    Arm Description

    Experimental protocol is executed in PD patients with STN DBS implant in STN DBS ON and OFF conditions

    Experimental protocol is executed in PD patients without STN DBS implant twice without experimental variable manipulation.

    Outcomes

    Primary Outcome Measures

    Reaction times and responses recorded at the moral task

    Secondary Outcome Measures

    Reaction times and responses recorded at the economics task

    Full Information

    First Posted
    September 1, 2014
    Last Updated
    October 28, 2020
    Sponsor
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    Collaborators
    Istituto Neurologico Nazionale IRCCS Casimiro Mondino, Pavia, Italy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02231645
    Brief Title
    Subthalamic Deep Brain Stimulation Effects on Decision-making Processing in Patients With Parkinson's Disease
    Official Title
    Subthalamic Deep Brain Stimulation Effects on Moral and Economics Decision-making Processing in Patients With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    Collaborators
    Istituto Neurologico Nazionale IRCCS Casimiro Mondino, Pavia, Italy

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Parkinson's disease, Deep brain stimulation, Subthalamic nucleus, decision-making, cognition, behavior

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    STN DBS group
    Arm Type
    Experimental
    Arm Description
    Experimental protocol is executed in PD patients with STN DBS implant in STN DBS ON and OFF conditions
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Experimental protocol is executed in PD patients without STN DBS implant twice without experimental variable manipulation.
    Intervention Type
    Device
    Intervention Name(s)
    STN DBS
    Intervention Description
    The DBS device is turned on and off by the physician.
    Primary Outcome Measure Information:
    Title
    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)
    Secondary Outcome Measure Information:
    Title
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Parkinson's disease For experimental group: STN DBS implant occurred no less than 6 months before and with optimal stimulation parameters Exclusion Criteria: Cognitive, behavioural and psychiatric symptoms
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alberto Priori, MD, PhD
    Organizational Affiliation
    Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Subthalamic Deep Brain Stimulation Effects on Decision-making Processing in Patients With Parkinson's Disease

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