跳至主要内容
临床试验/NCT05326724
NCT05326724招募中不适用

The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
concentration of Exosome

研究概览

简要总结

Stroke is the main cause of disability and the second main cause of dementia. Approximately 21.5% of patients develop dementia within 4 years after stroke. The main clinical manifestation of dementia is memory and cognitive impairment. At present, acetylcholinesterase inhibitors and NMDA glutamate receptor antagonists, were used for dementia treatment, but those drugs have limited efficacy. Exosome is an extracellular vesicle from the endosomal, size range from ~40 to 160 nm (average ~100 nm). It contains many cells including DNA, RNA, fat, and metabolites, as well as cytoplasm and cell surface proteins that play a role in regulating intercellular communication. Some studies believe that exosomes in the circulation are an ideal marker to reflect the pathological progress and recovery of stroke, and play a key role in the reorganization of tissues and the progress of neurodegeneration after stroke. Our previous studies have known that acupuncture can increase the long-term potentiation of hippocampal CA1 in rats with ischemic stroke, and improve learning-memory and neurological function. Therefore, the purpose of this study is to explore the role of acupuncture-induced exosome in the treatment of post-stroke dementia.

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
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of stroke.
  • MMSE score between 16 and 26.

排除标准

  • Those with serious diseases, such as heart failure, chronic failure or cancer patients, etc.
  • Intolerance to acupuncture treatment.
  • Allergy to acupuncture needles.
  • Refusal to sign the informed consent form.

结局指标

主要结局

concentration of Exosome

时间窗: 12 weeks

Alzheimer's Disease Assessment Scale-Cognitive Subscale scale

时间窗: 12 weeks

Higher scores indicate greater cognitive impairment.

Behavioural and Psychological Symptoms of Dementia scale

时间窗: 12 weeks

The greater cognitive impairment or dementia severity is associated with higher rates of some BPSD (Behavioral and psychological symptoms of dementia ).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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