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临床试验/NCT01953718
NCT01953718已完成不适用

A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
1
主要终点
Change of parameters (voltage, pulse width, frequency) during follow-up

研究概览

简要总结

The purpose of this study is to assess the impact of different parameters (voltage, pulse width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms in patients with Parkinson's disease (PD).

详细描述

In this observational study, we will retrospectively analyze the one-year follow-up data of 27 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University in the years 2008-2012. The data, including parameter settings and severity of motor symptoms indicated by Unified Parkinson's Disease Rating Scale (UPDRS) Part III scores, was collected during the patients' annual visit to the hospital for reprogramming. A correlation analysis will be conducted to investigate the relationship between change of a specific parameter and the subsequent change of motor scores.

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
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PD patients treated with bilateral STN DBS in the First Affiliated Hospital in the years 2008-2012

排除标准

  • Simultaneous participation in another clinical trial
  • Dementia (Mini Mental State Examination < 26)
  • Removal of DBS electrodes
  • Loss to follow-up

结局指标

主要结局

Change of parameters (voltage, pulse width, frequency) during follow-up

时间窗: at 12 months

Change of UPDRS Part III score and the relation to parameters

时间窗: at 12 months

Changes of tremor, rigidity, bradykinesia and postural stability scores evaluated by UPDRS Part III and the relation to parameters

时间窗: at 12 months

次要结局

  • Change of daily levodopa equivalent dosage (LED) during follow-up(at 12 months)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Ling

MD,PhD

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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