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临床试验/NCT02814201
NCT02814201已完成不适用

Study of Motor Slowing in Parkinson's Disease by a Computerized Mental Chronometry Paradigm

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2011年7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
55
试验地点
1
主要终点
SRT

研究概览

简要总结

Action slowing has been demonstrated in many diseases. Parkinson's disease (PD) and Huntington's disease (HD) are two neurodegenerative diseases affecting the basal ganglia, particularly the medial globus pallidus, and the clinical expression of these two diseases is characterized by a combination of motor and cognitive disorders, but with two opposing patterns of dysfunction. Action slowing has been demonstrated in both of these diseases and has been extensively studied in Parkinson's disease, suggesting a perceptive-cognitive origin. Far fewer studies have been conducted in Huntington's disease. However, all of these studies were performed with different methodologies in small cohorts and the value of the proposed study is to use a validated and standardized computerized mental chronometry paradigm, providing a better understanding of the mechanisms of action slowing in these two diseases and to more clearly define a disease-specific profile.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Agreeing to participate in the study
  • French mother tongue
  • MMSE > 20/30
  • Specific to the MP and MH:
  • Parkinson's disease:
  • defined by the criteria of the UKPDSBB
  • stage 1 , 2 or 3 Hoehn and Yahr (ON)
  • age of onset of the disease known
  • brain MRI performed during follow-up
  • Huntington disease :
  • genetically defined (CAG > 35)
  • weaning neuroleptic ( Tercian® and Solian® : 2 days; Haldol® : 5 days ; Tiapridal® and Xenazine : 1 day ; Zyprexa® : 4 days)
  • Early stage : Fahn and Shoulson I and II is a CFT score between 7 and 13

排除标准

  • Illiteracy, writing or reading difficulties
  • Visual perceptual auditory deficit or preventing reading, drawing, writing or understanding instructions
  • Visual hallucinations
  • Significant history may sound on cognition (unbalanced thyroid dysfunction, ischemic heart disease or embolic unstabilized or symptomatic, progressive neoplasia, chronic alcoholism weaned or not)
  • Current or previous neurological diseases other than MH or MP: ischemic cerebral vascular accident or bleeding, head injuries (loss of higher knowledge in 15 minutes), epilepsy requiring treatment.
  • Psychiatric disorders depression unless treated (stable treatment for 1 month)
  • Psychotropic treatment (except anxiolytic, antidepressant steady since 1 month)
  • Inability to achieve an autonomous operation without technical assistance over a distance of 20 meters.
  • Inability to stand without technical assistance for 30 seconds.

结局指标

主要结局

SRT

时间窗: Day 0

simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )

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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