Early Versus Late Application of Subthalamic Deep Brain Stimulation to Parkinson's Disease Patients With Motor Complications: a Multicentre, Prospective and Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores
研究概览
简要总结
Although deep brain stimulation of the subthalamic nucleus(STN DBS) has become the surgical treatment of choice for Parkinson's disease(PD), a consensus on the timing of surgery is lacking. This study is intended to demonstrate that early, compared with delayed, introduction of STN DBS is more beneficial for PD patients who have developed motor complications.
详细描述
In this prospective study, 200 PD patients will be recruited for STN DBS over three years, including 133 with motor complications existing for more than three years (late complication group) and 67 less than three years (early complication group). To make a comparison of therapeutic efficacy between the two groups, motor and non-motor symptoms will be assessed using specific rating scales and questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease with good response to levodopa(i.e. more than 30% improvement in the MDS-UPDRS Part III score after an acute levodopa challenge)
- •Presence of fluctuations and/or dyskinesias
- •Age ranging from 18 to 75 years old
- •Normal brain MRI
- •Absence of dementia (Mini Mental State Examination ≥ 26)
- •Absence of severe psychiatric diseases
- •Written informed consent
排除标准
- •Presence of severe metabolic diseases
- •Severe cardiac/respiratory/renal/hepatic diseases
- •Secondary parkinsonism or multiple system atrophy
- •Illiteracy or insufficient language skills to complete the questionnaires
- •Poor compliance and unreasonable expectation
- •Women who are pregnant or breast feeding
- •Simultaneous participation in another clinical trial
结局指标
主要结局
Changes in 39-item Parkinson's disease questionnaire (PDQ-39) scores
时间窗: From baseline to 4 years
Quality of life
次要结局
- Changes in time spent in the "on" state without troubling dyskinesia based on Parkinson's disease home diary(From baseline to 4 years)
- Changes in Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores(From baseline to 4 years)
- Severe adverse effects(From baseline to 4 years)
- Changes in MDS-UPDRS patient questionnaire (Part I B and Part II) scores(From baseline to 4 years)
研究者
Chen Ling
MD, PhD
First Affiliated Hospital, Sun Yat-Sen University