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临床试验/NCT05103072
NCT05103072已完成不适用

Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年7月27日最近更新:
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
1
主要终点
Increase of MDS UPDRS 3 score

研究概览

简要总结

Patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient.

The investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator.

The investigators can chose the plot using a software (Guide Xt), which can delete the exhausting test.

The investigators would like to study the non inferiority of this tool to choose the best plot .

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • •age : >18Y
  • •All patient with Parkinson disease eligible for sub thalamic surgery (CAPSIT criterias) in CHU AMIENS

排除标准

  • •patient doesn't consent

研究组 & 干预措施

testing all the plots

the investigator chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator (" plot by plot ")

Guide X Software

the investigator can chose the plot using a software (Guide Xt), which can delete the exhausting test

结局指标

主要结局

Increase of MDS UPDRS 3 score

时间窗: 3 months

The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS has four parts, namely, I: Non-motor Experiences of Daily Living; II: Motor Experiences of DailyLiving; III: Motor Examination; IV: Motor Complications.Twenty questions are completed by the patient/caregiver. Item-specific instructions and an appendix of complementary additional scales are provided.

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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