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临床试验/NCT01495897
NCT01495897已完成不适用

Adaptation Sensorimotrice, Cervelet et Mouvements Anormaux: Projet d'étude Oculomotrice

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 14 人开始时间: 2011年3月1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
14
试验地点
2
主要终点
Saccadic adaptation

研究概览

简要总结

Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Essential tremor is a slowly progressive neurologic disorder characterized by the appearance of a tremor during the voluntary movement. The pathophysiology of dystonia or essential tremor is not fully elucidated. Dystonia and essential tremor are associated with dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the cerebellum and cerebellar pathways has also been recently suggested.

The investigators propose to study 30 patients having a primary dystonia (15 DYT11 genetically documented), 15 patients having an essential tremor without deep brain stimulation and 15 patients having an essential tremor with deep brain stimulation.A group of 30 healthy volunteers will be recruited and tested according to the same modalities. They will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.

Eye position will be sampled with a video-based monocular eye tracker (SMI, Germany) before and immediately after an adaptation task. Saccade adaptation is evaluated as the percentage change in the mean saccade amplitude between pre-test and post-test.

Expected results:

  • no or fewer alteration of the performance to the adaptation task in the Parkinson group than in the Essential Tremor group/ dystonia group.
  • abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor group, providing further neurophysiological evidence of cerebellar dysfunction.

详细描述

Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Essential tremor is a slowly progressive neurologic disorder characterized by the appearance of a tremor during the voluntary movement. High frequency stimulation of the ventral intermedius nucleus (Vim) of the thalamus, relay for the cerebellar output, is successfully used for the treatment of severe essential tremor. It occasionally induces adverse event such as balance disorders or cerebellar symptoms. The pathophysiology of dystonia or essential tremor is not fully elucidated. Dystonia and essential tremor are associated with dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the cerebellum and cerebellar pathways has also been recently suggested. It seems that dystonia and essential tremor could be the result of basal ganglia or cerebellar dysfunction, or from dysfunction of structures controlled at the same time by the cerebellum and the basal ganglia.

methodology: We propose to study 30 patients having a primary dystonia (15 DYT11 genetically documented), 15 patients having an essential tremor without deep brain stimulation and 15 patients having an essential tremor with deep brain stimulation.

A group of 30 healthy volunteers will be recruited and tested according to the same modalities. They will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.

The subjects will be seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location. This avoided any post-saccadic visual feedback that would counteract the adaptive mechanism. Saccade adaptation is evaluated as the percentage change in the mean saccade amplitude between the pre-test and post-test.

Expected results:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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 ≥18 years
  • -normal cognitive functions (>24y)
  • Normal clinical examination of ocular mobility, visualization of the target
  • No drug potentially able to modify and to influence the data: anti-depressants, neuroleptics, anti-emetics, amphetamines, anti myoclonic/dystonic drugs, alcohol, dopaminergic drug, antiepileptic.
  • Dystonia or essential tremor or Parkinson: diagnostic made by a neurologist
  • For DYT11: mutation in SGCE gene.
  • For dystonia: No secondary dystonia
  • For Parkinson : UPDRS<28
  • No other neurological disorder
  • For the patient having deep brain stimulation:
  • Duration of stimulation> 6 months
  • Cerebral imagery post operation made
  • Stimulation parameter stable since 3 months at least.
  • Usual stop of the stimulation during the night

排除标准

  • Uncontrollable medical problems not related to M-D
  • Current active psychiatric disorder
  • Intake during the last 3 days of drugs potentially able to modify and to influence the data: anti-depressants, neuroleptics, anti-emetics, amphetamines, anti myoclonic/dystonic drugs, alcohol, dopaminergic drug
  • Subjects legally protected.
  • Subjects who are not enrolled at social security.

结局指标

主要结局

Saccadic adaptation

时间窗: between the pre-test and post-test, maximum 4 hours

Saccadic adaptation, evaluated as the percentage of changes in the mean saccade amplitude between the pre-test and post-test.

Characteristics of the saccade

时间窗: measured during the analysis of the recorded session, maximum 4 hours

latency, velocity, duration of the saccade

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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