NCT00855621Unknown不适用
Prognostic Factors in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) - a Prospective Randomized Double-blind Study (The NORSTIM Study)
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from baseline of the motor score of the New-UPDRS (part III) OFF medication
研究概览
简要总结
The purpose of this study is to identify factors predicting good results in patients treated with deep brain stimulation for Parkinson's disease. The study includes a comparison of two surgical methods used to provide this therapy.
详细描述
The study will prospectively examine the effects of deep brain stimulation of the subthalamic nucleus (STN-DBS) on motor function, quality of life and cognitive function in Parkinson's disease (PD) patients treated at Rikshospitalet University Hospital. The aim is to identify which factors that predict good treatment outcome, in order to improve patient selection of this generally highly effective, but specialized and expensive treatment.
The study has several aims:
- Randomized double-blind evaluation of the impact of using single vs. multiple electrode-recordings to guide electrode placement.
- To identify factors predicting good effect on motor function and improvements of quality of life after deep brain stimulation of the subthalamic nucleus.
- To identify cognitive and psychiatric changes related to deep brain stimulation of the subthalamic nucleus
- To study social functioning of patients after STN-DBS and quality of life of patient caregivers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of Parkinson's disease
- •Symptoms ≥ 5 years
- •Severity of Parkinson's disease ≥ 20 points in UPDRS motor scale (scale 0-108) in OFF medication state
- •Marked fluctuations of motor symptoms AND/OR troublesome dyskinesias AND/OR severe tremor AND/OR intolerable side-effects of dopaminergic drugs
- •Failure of medical treatment to sufficiently control symptoms
- •L-dopa responsive symptoms with ≥30% reduction in UPDRS motor score in drug ON state compared to OFF state OR severe l-dopa unresponsive tremor
排除标准
- •Previous surgery for Parkinson's disease
- •Marked axial motor symptoms unresponsive to treatment with l-dopa
- •Dementia (Mattis dementia rating scale < 130).
- •Patient suffering from untreated moderate or major depression or anxiety disorder
- •Presence of other psychiatric disorder preventing necessary co-operation
- •Brain MRI showing marked atrophy or white matter changes
- •Increased risk of bleeding
- •Presence of medical illness with short life expectancy
- •Other surgical contra-indications
结局指标
主要结局
Change from baseline of the motor score of the New-UPDRS (part III) OFF medication
时间窗: 12 months
次要结局
- Frequency of new or worsened psychiatric symptoms(12 months)
- Change in social functioning (Social adjustment scale-SR)(12 months)
- Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life)(12 months)
- Change from baseline in Mattis Dementia Rating Scale score(12 months)
- Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index)(12 months)
- Change from baseline of Clinical Dyskinesia Rating Scale score(12 months)
- Change from baseline in ADL function (UPDRS part II)(12 months)
研究者
Mathias Toft
Consultant neurologist
Oslo University Hospital
研究点 (2)
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