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临床试验/NCT05839132
NCT05839132尚未招募不适用

Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
76
试验地点
1
主要终点
plasma levels of Aβ peptide

研究概览

简要总结

Traumatic brain injury (TBI) is an altered brain function caused by an external force, which may annually have 69 million incidence cases all over the world. Increasing evidence suggests that TBI may be a major risk of beta amyloid (Aβ)-associated neurodegenerative disorders, such as Alzheimer's disease, frontotemporal dementia, and Parkinson's disease. Investigations from brain imaging studies revealed that Aβ density maps of TBI patients overlapped with those with Alzheimer's disease, and increased Aβ density not only associated with prolonged TBI duration but also associated with decreased white matter integrity. It has been suggested that the axonal injury and cerebrovascular dysfunction due to TBI may associate with the elevated level of Aβ peptides. The increasing accumulation in Aβ due to TBI may contribute to the initiation of the pathological alterations in neurodegeneration diseases. Recent animal studies suggest that acupuncture may promote regeneration of nerves in injured tissues and reduce the concentration of Aβ in brain. Moreover, recent clinical trials also indicate that acupuncture may improve the vascular cognitive impairment due to cerebral small vessel disease. Thus, acupuncture treatment on TBI may not only be of benefit for the TBI recovery but also act to interrupt the pathological changes in these neurodegenerative diseases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age ≥ 20 years old
  • •GCS score > 8
  • •loss of consciousness < 24 hr
  • •the physical condition is suitable for acupuncture treatment
  • •having adequate competency for understanding the study and a willingness to sign the written informed consent forms
  • •be able to commence the acupuncture intervention within 2 weeks after TBI diagnosis

排除标准

  • •medical history of neurological, cardiovascular events, e.g., epilepsy, stroke, major depression or anxiety
  • •a history of the mental disorder, e.g., major depression or anxiety
  • •other major medical conditions, e.g., active cancer, uncontrolled diabetes, amputation
  • •receipt of acupuncture within the 6 months prior to study entry
  • •patients with pacemaker or metal graf

研究组 & 干预措施

acupuncture treatment group

Experimental

Disposable acupuncture needles will be inserted into acupoints for a depth of 20-30 mm in a direction oblique or parallel to the surface. To ensure allocation concealment, all needles will be affixed with plastic O-rings and adhesive tapes.

Acupuncture points: Baihui(DU20), Sishencong(EM1), Hegu(LI4), Taichong(LR3)

干预措施: Acupuncture (Procedure)

sham acupuncture treatment group

Placebo Comparator

Streitberger's non-invasive placebo acupuncture needles will be used in the control group; blunt-tipped needles will touch the skin quickly without being inserted. To ensure allocation concealment, all needles will be affixed with plastic O-rings and adhesive tapes.

Acupuncture points: Baihui(DU20), Sishencong(EM1), Hegu(LI4), Taichong(LR3)

干预措施: Acupuncture (Procedure)

结局指标

主要结局

plasma levels of Aβ peptide

时间窗: After 2-week acupuncture treatment interva

Decreased plasma levels of Aβ peptide

plasma levels of tau

时间窗: After 2-week acupuncture treatment interva

Decreased plasma levels of tau

plasma levels of glial fibrillary acidic protein (GFAP)

时间窗: After 2-week acupuncture treatment interva

Decreased plasma levels of glial fibrillary acidic protein (GFAP)

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

Yu-Chen Lee

professor

China Medical University Hospital

研究点 (1)

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