Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Orthostatic blood pressure change
研究概览
简要总结
The aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension.
详细描述
Parkinson's disease (PD) is one of the most common neurodegenerative disorders with increasing prevalence because of aging population. The main symptoms include rigidity, hypokinesia, tremor and impaired balance, but the disease also causes autonomic dysfunction. Motor fluctuations are common treatment related problems in PD, around 50-70% of patients treated with levodopa finally develop motor fluctuations. Continuous duodenal levodopa infusion has been effective in the treatment of motor dysfunction in advanced PD. However, little is known of its effects on autonomic nervous system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease: diagnosis made at least five years earlier
- •Positive response to levodopa
- •Motor fluctuations that cannot be adequately controlled with oral medication
- •No signs or symptoms of cerebellar dysfunction or vascular parkinsonism
排除标准
- •Severe cognitive symptoms
- •Severe arrythmias
- •Severe asthma or COPD
- •Heart, liver or kidney failure
- •No significant vascular lesions in brain MRI imaging.
研究组 & 干预措施
Levodopa Infusion
Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.
干预措施: Levodopa infusion (Drug)
结局指标
主要结局
Orthostatic blood pressure change
时间窗: Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started
次要结局
- Sweating measured by evaporimeter(Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started)
- Autonomic nervous system symptoms questionnaire (NMSS)(Before levodopa infusion and 2 months after levodopa infusion was started)
- Quality of life questionnaire (PDQ-39)(Before levodopa infusion and 2 months after levodopa infusion was started)