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临床试验/NCT02652104
NCT02652104已完成不适用

A Review of the Clinical Outcome of Deep Brain Stimulation in the Patients With Advanced Parkinson's Disease in Helsinki and Uusimaa Hospital Between 2006 to 2014

Hospital District of Helsinki and Uusimaa0 个研究点目标入组 140 人开始时间: 2006年1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
140
主要终点
The benefit of deep brain stimulation in the well-being (measured in UPDRS III, H&Y scale) of a patient with advanced Parkinson's disease

研究概览

简要总结

This study reviews the outcome of deep brain stimulation treated patients in Helsinki and Uusimaa University Hospital between 2006 and 2014. The aim of the study is to investigate the outcome and possible side effects of deep brain stimulation treatment.

详细描述

Deep brain stimulation is a FDA approved method in treating patients with advanced Parkinson's disease when the best medical treatment is insufficient. In this study the aim is to investigate the outcome of deep brain stimulation treated patients in Helsinki and Uusimaa University hospital between 2006 and 2014. This study is a retrospective study based on existing patients' medical records and does not include an intervention in the treatment of an individual patient.

Deep brain stimulation carries the risks of major surgery. A complication risk for a hemorrhage is 1-2 % and for an infection is 3-10%. The aim of this study is to evaluate the complications that have occurred and the possible benefit of deep brain stimulation in deep brain stimulation treated patients with advanced Parkinson's disease.

The gathered data will be processed anonymously and an individual patient cannot be identified. The data will be processed with an appropriate statistical program (SPSS). No data will be given to external parties.

研究设计

研究类型
Observational
观察模型
Case Only

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient with advanced Parkinson's disease and given deep brain stimulation according to the best clinical protocol. This study only observes the outcome of given deep brain stimulation and does not affect on the given treatment.

排除标准

  • •The normal exclusion criteria for deep brain stimulation which are dementia, a significant vascular atrophy seen in brain CAT scan or MRI, Parkinson's disease with non-levodopa response with less than 30 % improvement in levodopa challenge test, disease duration less than 5 years

结局指标

主要结局

The benefit of deep brain stimulation in the well-being (measured in UPDRS III, H&Y scale) of a patient with advanced Parkinson's disease

时间窗: at six months post-DBS

次要结局

  • The possible complications of deep brain stimulation in patient with advanced Parkinson's disease(years)
  • The possible decrease in dosage of anti-Parkinsonian drugs after deep brain stimulation(years)

研究者

发起方
Hospital District of Helsinki and Uusimaa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maija Koivu

specialising physician

Hospital District of Helsinki and Uusimaa

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