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临床试验/NCT02126475
NCT02126475已完成不适用

L'Expectation Temporelle Dans la Maladie de Parkinson : étude Oculomotrice Psychophysique et Par électroencéphalographie

Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
oculomotor reaction time: saccade latency

研究概览

简要总结

Although major progresses were realized during recent years, temporal cognition is still poorly understood. However, abnormal temporal cognition is an underestimated aspect of several neurological disorders, particularly if basal ganglia (BG) are affected. Therefore, the interest of studying temporal cognition is double: firstly, it is an essential function necessary to guide all behavior; secondly, it seems to be very sensitive to the integrity of dopaminergic pathways. It is well known that Parkinson's disease (PD) is partly due to a degeneration of neurons producing dopamine in the Substantia Nigra pars compacta (SNc). Therefore, in this project, PD patients and healthy volunteers will be used as a model to study the role of dopamine in temporal expectation.

An expectation is an internal representation of an event that is likely to occur in the future. Temporal expectation builds-up as time elapses before the upcoming event. The role of temporal expectation in the oculomotor domain has often been studied using anticipatory eye movements as a tool. Indeed, expectation evokes anticipatory eye movements. However, to the knowledge of the investigators, expectation and anticipation have so far been studied in experimental tasks where temporal information is essential but not voluntarily controlled. This is usually referred to as 'automatic' or 'emergent' timing: the timing of the eye movement adapts to the timing of the target, implicitly and without voluntary control of the subject. However, anticipatory movements can also be based on an explicit estimation of time, e.g. during music playing. In summary, timing can be based on cognitive (explicit) or automatic (implicit) processing. The originality of the behavioral task the investigators will use in this study is that it will require an explicit comparison of a memorized duration with elapsing time in order to anticipate target appearance. In this task, expectation of the upcoming event will build up on explicit temporal information.

Same PD patients will be tested under treatment ("ON") and without treatment ("OFF") to determine the effect of dopamine in time expectation . Only levodopa responsive Parkinson patients will be included and among them only those receiving levodopa and/or dopa agonists three times daily at a stable dosis since 30 days.

the investigators hypothesize that eye movements latency will not linearly covary with objective time in "OFF" PD patients. In treated PD patients, a recovery of the linear relationship between subjective and objective time is expected. This would clearly demonstrate the role of dopamine in temporal expectation in humans.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy volunteers :
  • •Men or women, age: 18 to 65 years old
  • •Subject affiliated to a national insurance scheme
  • •Informed consent of the study signed
  • •Normal neurological exam
  • •Men or women, age: 18 to 65 years old
  • •Subject affiliated to a national insurance scheme
  • •Informed consent of the study signed
  • •Idiopathic Parkinson disease, UKPDSBB criteria (Hughes, Ben-Shlomo, Daniel, & Lees, 1992; Hughes, Daniel, Kilford, & Lees, 1992; Hughes, Daniel, & Lees, 2001)
  • •Non fluctuant patients
  • •Patients treated by L-Dopa +/- other anti-Parkinsonian's, stable dose for 30 days

排除标准

  • •Cognitive or behavioural disorder
  • •Severe psychiatric symptomatology and psychotropic drug use
  • •Subject non-affiliated to a national insurance scheme
  • •No signature of the Informed consent of the study
  • •Subject freedom-deprived by court or administrative order

结局指标

主要结局

oculomotor reaction time: saccade latency

时间窗: at least 21 days after inclusion

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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