NL-OMON50651招募中不适用
Infusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's disease comparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treetment Deep Brain Stimulation; - INVEST (Infusion VErsus STimulation) study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- idiopathic Parkinson's Disease with bradykinesia and at least two of the
- •following signs; resting tremor, rigidity, and asymmetry;
- •- despite optimal pharmacological treatment, at least one of the following
- •symptoms: severe response fluctuations, dyskinesias, painful dystonia or
- •bradykinesia;
- •-a life expectancy of at least two years.
排除标准
- •-age below 18 years
- •- previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);
- •- previous CLI (through a PEG-tube or Nasal Jejuna| tube);
- •- Hoehn and Yahr stage 5 at the best moment during the day;
- •- dementia or indication for severe cognitive impairment, such as PD-CRS <65;
- •- psychosis;
- •- current depression;
- •- other, severely disabling condition;
- •- contraindications for DBS surgery, such as a physical disorder making surgery
- •- contraindications for PEG surgery such as interposed organs, ascites and
- •oesophagogastric varices, or for Duodopa;
- •- pregnancy, breastfeeding, and women of child bearing age not using a reliable
- •method of contraception;
- •- No informed consent;
- •- legally incompetent adults.
研究者
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