跳至主要内容
临床试验/NCT02672943
NCT02672943Unknown不适用

The Role of Noradrenergic Network, and Its Association With Autonomous Dysfunction,Cerebral Autoregulation and microRNA in Parkinson Disease Before and After Medication and Rehabilitation Treatment

Chang Gung Memorial Hospital0 个研究点目标入组 60 人开始时间: 2016年1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
60
主要终点
Neuroimage

研究概览

简要总结

In this three-year project, our research teams are going to consecutively explore these important clinical, drug and physical rehabilitation treatment effects, noradrenergic network, autonomic dysfunction and microRNA signalling data as well as the correlations between them in early Parkinson Disease (PD) patients. The investigators hypothesize that the explorations of the above insights are unique and can provide an important source data for Taiwanese Parkinson Disease (PD).

详细描述

(1) 70 patients with PD. (2) 30 age and sex-match controls.

Methods:

-1st year To built up the biobank of 30 early PD patients (Hoehn and Yahr stage 1-3) and 30 health controls in all examination.

The PD patients will accept the MRI, autonomic dysfunction, and peripheral microRNA examination and their correlations among each other at least 12 hours after the least medication.

-2nd year Second year, the investigators will follow-up the 30 PD patients enrolled in the 1st years.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In this study, the patients should be 40-75 years of age and identified as PD. PD patients with an early clinical stage (Hoehn and Yahr stage 1-3) will be enrolled in this study. The informed written consent which is approved by Ethics Committee of our hospital will be obtained from the patient or their family.

排除标准

  • Patients with the following conditions are excluded:
  • Atherosclerotic narrowing on intracranial and extracranial vessels (>50% stenosis) with or without evidence of old cerebral infarctions, coronary artery diseases status post percutaneous transluminal coronary angioplasty or bypass surgery and renal failure requiring hemodialysis or peritoneal dialysis
  • Moderate to severe heart failure (NYHA class III and IV).
  • Central or peripheral disorders known to affect autonomic nervous systems.

结局指标

主要结局

Neuroimage

时间窗: 12 weeks

Conventional MRI, Rest function MRI Image Data Preprocessing, Assessment of cerebral blood flow with Arterial Spin Labeling (ASL) MRI and Chemical Exchange Saturation Transfer

次要结局

  • Physical Rehabilitation_1(12 weeks)
  • Physical Rehabilitation_3(12 weeks)
  • Physical Rehabilitation_4(12 weeks)
  • Biochemical Analysis(18 months)
  • Physical Rehabilitation_2(12 weeks)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

相似试验