Remote Ischemic Conditioning AS Adjuvant Therapy for Parkinson's Disease: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Unified Parkinson's disease Rating Scale - Session III
研究概览
简要总结
The purpose is to evaluate feasibility and efficacy of Remote Ischemic Conditioning(RIC) as adjuvant therapy for Parkinson's Disease(PD). Sixty patients will be randomized into 2groups: RIC group receiving Remote Ischemic Conditioning except conventional therapy（n=30）and control group with conventional therapy (n=30).
详细描述
Remote ischaemic conditioning (RIC) is a procedure whereby ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms to above systolic pressures (mmHg). This procedure induce neurohormonal, systemic or vascular changes in the body. Such changes often result in improved collateralisation of blood supply to various areas of the body, as well as improved efficiencies of cellular metabolism. RIC has been shown to improve outcomes in patients with heart attacks, strokes, but is not investigated for PD. We argue that RIC may exert neuroprotective effect on PD due to its multiple mechanisms. The aim of the study is to evaluate the impact of RIC on long term outcomes in patients with PD.
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
- Single (Outcomes Assessor)
盲法说明
a single-blind (outcomes assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 - 70 years;
- •diagnosed with idiopathic PD;
- •a rating of 1-3 on the Hoehn and Yahr Scale;
- •On optimized dopaminergic therapy for 4 weeks prior to enrollment;
- •Be able to complete the research scale evaluation;
- •sign informed consent.
排除标准
- •Atypical Parkinsonism or other significant brain conditions such as a stroke;
- •Significant mental disease or psychosis;
- •History or presence of significant peripheral vascular disease in the upper limbs;
- •Presence of skin ulceration to the arms;
- •Deep Brain Stimulation ( DBS);
- •Taking part in another clinical trial of an investigational medicinal product;
- •Life expectancy less than 1 year due to Severe medical disease;
- •other reasons that are unsuitable for the trial in the investigator's opinion.
结局指标
主要结局
Change in Unified Parkinson's disease Rating Scale - Session III
时间窗: 24weeks
The Unified Parkinson´s Disease Rating Scale Part Ⅲ is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 (Best score possible) to 108 (Worst score possible).
次要结局
- Changes on quality of life(12 weeks, 24weeks, 48 weeks)
- Change in Unified Parkinson's disease Rating Scale - Session III(12 weeks, 48 weeks)
- Changes on Depression(12 weeks, 24weeks, 48 weeks)
- Changes on Cognitive function(12 weeks, 24weeks, 48 weeks)
- Levodopa Equivalent Dose(12 weeks, 24weeks, 48 weeks)
- frequency of adverse events(From screening up to 48 weeks)
研究者
Hui-Sheng Chen
Director of neurology department
General Hospital of Shenyang Military Region