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临床试验/NCT02231645
NCT02231645已完成不适用

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

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico0 个研究点目标入组 22 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
主要终点
Reaction times and responses recorded at the moral task

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Cognitive, behavioural and psychiatric symptoms

结局指标

主要结局

Reaction times and responses recorded at the moral task

时间窗: For the experimental group these measures are collected in ON and OFF STN DBS (30 minutes pass between the ON and OFF condition)

次要结局

  • Reaction times and responses recorded at the economics task(For the experimental group these measures are collected in ON and OFF STN DBS (30 minutes pass between the ON and OFF condition))

研究者

申办方类型
Other
责任方
Sponsor

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