Clinical Effect of Acupuncture in Neurodegenerative Diseases on Traumatic Brain Injury Patients
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
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
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
Yu-Chen Lee
professor
China Medical University Hospital
