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临床试验/NCT02885194
NCT02885194已完成不适用

Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease : Clinical and Neurophysiological Study

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2015年1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
26
试验地点
2
主要终点
Modification of habituation in percentage, between tests performed before and after DBS

研究概览

简要总结

Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS) could make a profit on the pain in PD.

The investigator would drive a study with a follow up of PD patients before and after STN-DBS. The pain will be clinically explored by targeted questionnaires and electrophysiological through laser evoked potentials.

The questionnaires are designed to quantify and characterize the pain in these patients. Laser evoked potentials will, through repetitive stimulation, study both the functional status of the afferent nociceptive pathways, their habituation to repetitive nociceptive stimuli, and so better understand any abnormalities of the central processing of nociceptive information.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A patient with idiopathic Parkinson's disease
  • Age between 30 and 70 inclusive.
  • No cognitive decline (MMS greater than or equal to 24)
  • Normal brain MRI
  • Informed consent signed
  • With or without pain sensation

排除标准

  • Presence of other neurological pathology that could explain the pain.
  • MMS less than 24
  • Pregnant or breastfeeding women

结局指标

主要结局

Modification of habituation in percentage, between tests performed before and after DBS

时间窗: After the second laser evoked potential which occurred around 3 months after STN-DBS

The habituation is the change of amplitude between the first and the second response of the double stimulation during the laser evoked potential. We calculated a percentage

次要结局

  • Change in latency of laser evoked potential responses before and after DBS(After the second laser evoked potential which occurred around 3 months after STN-DBS)
  • Change in amplitude of laser evoked potential responses before and after DBS(After the second laser evoked potential which occurred around 3 months after STN-DBS)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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