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临床试验/NCT01223144
NCT01223144已完成不适用

Decision-making and Emotion Recognition in Essential Tremor

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
Comparison of the performance in the Iowa Gambling Task and the Ekman facial recognition test

研究概览

简要总结

The present study aims at investigating cognitive functions requiring orbitofrontal control, namely decision-making and facial emotion recognition. The investigators hypothesize that decision-making and facial emotion recognition are impaired in patients with essential tremor (ET) due to frontal lobe dysfunction which may have consequences in daily social life.

详细描述

Beyond tremor, ET patients display a wide spectrum of clinical abnormalities such as ataxia, deafness, olfactory disturbances, cognitive dysfunction and personality changes. Cognitive dysfunction mainly consists in a dysexecutive syndrome. Personality changes are characterized by increased harm avoidance. These findings suggest a complex modification in frontal lobe function in ET patients, including aspects of dorsolateral and orbitofrontal control. Previous studies have exclusively focused on dorsolateral prefrontal control, while orbitofrontal aspects remain to be elucidated. Orbitofrontal areas are involved in processing emotion and reward, as well as normal social behavior. Dysfunction in these regions may have direct consequences in daily social life.

We hypothesize that decision-making and facial emotion recognition are impaired in ET patients due to frontal lobe dysfunction which may have consequences in daily social life. The first aspect can be assessed with the Iowa Gambling Task, a simple paradigm that simulates real-life decision-making. Briefly, players are given four decks of cards, a loan of $ 2,000 and asked to play so they can lose the least amount of money and win the most. Turning each card carries an immediate reward and sometimes an unpredictable penalty. Decks A and B are the most disadvantageous leading to an overall loss of money, while decks C and D are the most advantageous with an overall gain of money. In contrast to control subjects, patients with damage of the orbitofrontal or ventromedian cortex continue to perseverate with the bad decks, sometimes even though they know that they are losing money overall. The second aspect, i.e. the recognition of facial emotion can be assessed in a simple paradigm where patients have to choose the best fitting response among six facial expressions (happiness, sadness, fear, surprise, disgust and anger) that are presented in random order. All study subjects will be tested with the Benton Visual Retention Test to exclude impairment in visual perception, visual memory or visuoconstructive abilities.

Performances in the Iowa Gambling Task and the facial emotion recognition test will be compared between ET patients and controls. All study subjects will also be tested with the following battery: Modified Card Sorting Test, Stroop, Trail Making Test and Verbal Fluency, Beck Depression Inventory and the Mattis Dementia Rating Scale. These tests will allow assessing the impact of executive function, depression and memory loss on performances in the Iowa Gambling Task and the facial emotion recognition test. Finally, performances in the Iowa Gambling Task and the facial emotion recognition test will be related to sex, age, disease duration and tremor severity.

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
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

  • Age over 18 years
  • Patient diagnosed as having essential tremor
  • Written informed consent
  • Patient covered by the French health insurance system
  • Age over 18 years
  • No diagnosis of essential tremor
  • Written informed consent
  • Subject covered by the French health insurance system

排除标准

  • Dementia (MMSE<24) or other known illness which could impact motor and cognitive performances
  • Patient unable to give written informed consent
  • Same exclusion criteria as for patients

研究组 & 干预措施

age- and sex-matched control subjects

Active Comparator

age- and sex-matched control subjects

干预措施: Iowa Gambling Task and Ekman facial recognition test (Behavioral)

Patients with essential tremor

Experimental

Patients with essential tremor

干预措施: Iowa Gambling Task and Ekman facial recognition test (Behavioral)

结局指标

主要结局

Comparison of the performance in the Iowa Gambling Task and the Ekman facial recognition test

时间窗: 1 day (duration of study)

Comparison of the performance in the Iowa Gambling Task and the Ekman facial recognition test between patients and age- and sex-matched controls. * Iowa Gambling Task: mean number of cards chosen from decks with low (A+B) and high gain (C+D). * Ekman facial recognition test: mean number of faces correctly recognized (60 images with 6 different expressions: happiness, sadness, fear, surprise, disgust and anger).

次要结局

  • Risk anticipation as assessed by the number of advantageous minus disadvantageous choices in the Iowa Gambling Task.(1 day (duration of study))
  • Assessment of the relation between the primary outcome measures and age, sex, disease duration, as well as tremor severity.(1 day (duration of study))
  • Assessment of the relation between the primary outcome measures and executive function and depression.(1 day (duration of study))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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