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临床试验/NCT00922909
NCT00922909已完成不适用

Executive Control Analysis in Patients Suffering From Parkinson Disease and Treated by Deep Brain Stimulation (Chronometric and Electromyographic Approach During a Simon Task)

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
to assess the effect of subthalamic stimulation on the patients' performance in a Simon task.

研究概览

简要总结

Different results have recently led to question the classical notion according to which the motor and cognitive deficits in Parkinson's disease are tied to a thalamo-cortical inhibition due to the degeneration of the dopaminergic nigro-striatal pathways. Instead, Parkinsons's disease seems accompanied by an increase in motor cortical activity.

A reaction time task, known as the "Simon task" in the literature, allows one to study the influence of irrelevant visual information on decision making. In the most common version of this task (used in the prosed study), the subjects have to choose between a left- and a right-hand keypress according to the color of a visual signal presented either to the left or to the right of a fixation. The to be established association is said "congruent" when the response is ipsilateral to the stimulus and "incongruent" when the response is contralateral to the stimulus. In healthy volunteers, EMG investigations have revealed that in a significant numbers of trials, the contraction of the response agonist is preceded by a infra-liminal contraction of the agonist involved in the non-required response. Such "partial errors" demonstrate that the nervous system is able to detect, abort and correct a part of its errors, thereby revealing the existence of an on-line executive control in simple decision tasks. Behavioral studies performed in Parkinson disease patients, suggest that these patients may experience a deficit in such a control.

The present study aims at testing this hypothesis by assessing the effect of subthalamic stimulation on the patients' performance in a Simon task.

详细描述

Different results have recently led to question the classical notion according to which the motor and cognitive deficits in Parkinson's disease are tied to a thalamo-cortical inhibition due to the degeneration of the dopaminergic nigro-striatal pathways. Instead, Parkinsons's disease seems accompanied by an increase in motor cortical activity.

A reaction time task, known as the "Simon task" in the literature, allows one to study the influence of irrelevant visual information on decision making. In the most common version of this task (used in the prosed study), the subjects have to choose between a left- and a right-hand keypress according to the color of a visual signal presented either to the left or to the right of a fixation. The to be established association is said "congruent" when the response is ipsilateral to the stimulus and "incongruent" when the response is contralateral to the stimulus. In healthy volunteers, EMG investigations have revealed that in a significant numbers of trials, the contraction of the response agonist is preceded by a infra-liminal contraction of the agonist involved in the non-required response. Such "partial errors" demonstrate that the nervous system is able to detect, abort and correct a part of its errors, thereby revealing the existence of an on-line executive control in simple decision tasks. Behavioral studies performed in Parkinson disease patients, suggest that these patients may experience a deficit in such a control.

Aims

The present study aims at testing this hypothesis by assessing the effect of subthalamic stimulation on the patients' performance in a Simon task.

Methods

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Parkinson disease
  • Mattis score > 130,MMSE > 24
  • No subthalamic stimulation for 6 months
  • No depressive disease evoluting

排除标准

  • Colorblindness
  • Psychotropic treatment introduced for less than a month

研究组 & 干预措施

2

Active Comparator

Day 1 : morning : Medication on ; Stimulation : off afternoon : Medication : on ; Stimulation : on Day 2 : morning : Medication : off ; Stimulation : off afternoon : medication : off ; stimulation : on

干预措施: Simon task (Behavioral)

3

Active Comparator

Day 1 : morning : Medication off ; Stimulation : on afternoon : Medication : off ; Stimulation : off Day 2 : morning : Medication : on ; Stimulation : on afternoon : medication : on ; stimulation : off

干预措施: Simon task (Behavioral)

4

Active Comparator

Day 1 : morning : Medication off ; Stimulation : off afternoon : Medication : off ; Stimulation : on Day 2 : morning : Medication : on ; Stimulation : off afternoon : medication : on ; stimulation : on

干预措施: Simon task (Behavioral)

1

Active Comparator

Day 1 : morning : Medication on ; Stimulation on afternoon : Medication on ; Stimulation off Day 2 : morning : Medication off ; Stimulation on afternoon : Medication off ; Stimulation off

干预措施: Simon task (Behavioral)

结局指标

主要结局

to assess the effect of subthalamic stimulation on the patients' performance in a Simon task.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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