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临床试验/NCT02759159
NCT02759159Unknown不适用

The Study of Brain Functional Network Modulatory Mechanism of Alzheimer's Disease Using Acupuncture at the "Four-gate" Acupoints

Xuanwu Hospital, Beijing2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
brain functional connectivity

研究概览

简要总结

Alzheimer's disease (AD) is one of the major brain diseases which received more attention in recent years. The disconnection syndrome is the main pathophysiological mechanism leading to cognitive decline in AD patients. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on AD patients by moderating the neural pathway directly. However, the underlying mechanism remains unclear. By using resting state functional magnetic resonance imaging (fMRI) method, as well as acupuncture and neurology sciences, investigators will explore the multi-modality data analysis; compare brain connectivity and network parameters changes between pre- and post- acupuncture treatment; analyze the correlation between fMRI changes and neuropsychology test. The present study aims to elucidate the neural mechanism of acupuncture therapy on early AD, provide theoretical evidence from the perspective of functional connectivity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of Alzheimer's Disease Clinical diagnosis of MCI due to Alzheimer's Disease Drug therapy regularly

排除标准

  • •Frontotemporal dementia Lewy body dementia Vascular dementia Severe depression Brain vascular disease Metabolic disease

研究组 & 干预措施

AD-true acupuncture

Experimental

True acupuncture at the "four-gate"acupoints will be administered on AD patients

干预措施: true acupuncture (Procedure)

AD-sham acupuncture

Sham Comparator

Sham acupuncture at the "four-gate"acupoints will be administered on AD patients

干预措施: sham acupuncture (Procedure)

Mild Cognitive Impairment(MCI)-true acupuncture

Experimental

True acupuncture at the "four-gate"acupoints will be administered on MCI patients

干预措施: true acupuncture (Procedure)

MCI-sham acupuncture

Sham Comparator

Sham acupuncture at the "four-gate"acupoints will be administered on MCI patients

干预措施: sham acupuncture (Procedure)

结局指标

主要结局

brain functional connectivity

时间窗: with in first week after the whole acupuncture treatment

GE750 3.0T gradient-echo single-shot echo plannar imaging TR=2000ms TE=30ms slice=36 slice thickness=3mm gap=1mm volumes=180

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

likuncheng

Head of Radiology Department

Xuanwu Hospital, Beijing

研究点 (2)

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