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临床试验/NCT02071693
NCT02071693已完成不适用

Cholinergic Pathways Hyperintensities Scale Could Not Predict the Change of Cognitive Status of Parkinson's Disease Patients After Bilateral STN DBS.

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2013年12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
38
试验地点
1
主要终点
Change of MoCA score during follow-up and its relationship with preoperative CHIPS score

研究概览

简要总结

To retrospectively investigate the relationship between the Cholinergic Pathways Hyperintensities Scale (CHIPS) score and the change of cognitive status of Parkinson's disease (PD) patients after bilateral subthalamic nucleus deep brain stimulation (STN DBS).

详细描述

In this observational study, we will retrospectively analyze 38 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University during the year of 2008-2012. All patients will be evaluated by Unified Parkinson's Disease Rating Scale part III(UPDRSIII) before and after operation. Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment(MoCA) in the on medication condition pre-operation and on stimulation on medication condition post-operation. The follow-up time points are one week pre-operation and 6, 12, 24 months post-operation. Before operation, white matter hyperintensities(WMHs)in the cholinergic pathways will be determined on a 3.0 Tesla MRI, using the visual rating scale of Cholinergic Pathways Hyperintensities Scale (CHIPS). A correlation analysis will be conducted to investigate the relationship between CHIPS score and the change of cognitive status of PD patients after bilateral STN DBS retrospectively.

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

  • Clinical diagnosis of Parkinson's disease according to United Kingdom Parkinson's Disease Brain Bank Criteria
  • Experience bilateral STN DBS surgery in the First Affiliated Hospital, Sun Yat-sen University, China.
  • Preoperative 3.0 Tesla MRI scanning.

排除标准

  • Loss to follow-up
  • Participation in other clinical trials

结局指标

主要结局

Change of MoCA score during follow-up and its relationship with preoperative CHIPS score

时间窗: Pre-operation and 6, 12, 24 months post-operation

Change of MMSE score during follow-up and its relationship with preoperative CHIPS score

时间窗: Pre-operation and 6, 12, 24 months post-operation

次要结局

  • Change of UPDRS III score during follow-up and its relationship with preoperative CHIPS score(Pre-operation and 6, 12, 24 months post-operation)

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

Doctor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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