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临床试验/NCT05072015
NCT05072015尚未招募不适用

Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年2月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement

研究概览

简要总结

Primary purpose: Fluctuations and dyskinesia evolution in Parkinson's disease patients, one year after initiation of deep brain stimulation, apomorphin pump or duodopa pump

Secundary purposes:

  • Motor complications evolution at 6 months, 2 and 3 years
  • MDS UPDRS III score at 6 months, 1, 2 and 3 years
  • non motor complications evolution at 6 months, 1, 2 and 3 years
  • cognition and psychiatric complications evolution at 6 months, 1, 2 and 3 years
  • cutaneous and digestive complications at 6 months, 1, 2 and 3 years
  • neuropathy occurrence at 6 months, 1, 2 and 3 years
  • medical treatment and Levodopa equivalent dose modifications at 6 months, 1, 2 and 3 years

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement

时间窗: 1 year

Evaluate the evolution of motor fluctuations and dyskinesias at one year in patients. treated with one of the 3 TSLs (bilateral stimulation of the subthalamic nucleus, apomorphine pump and duodopa pump. the higher the score, the more the disease is installed

次要结局

未报告次要终点

研究者

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

研究点 (1)

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