Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment
Vascular cognitive impairment (VCI) is a broad dimensional term, ranging from mild cognitive impairment without incapacity on activity of daily living to vascular dementia (VaD), referred to as significant cognitive impairment and decline in function status.
In this three-year project, we aim to evaluate the effects of biochemical data, early clinical variables, neuroimaging results, and intervention of acupuncture treatment on vascular event related cognitive impairment in crossectional analysis and longitudinal follow-up.
研究概览
详细说明
Stroke is a common cerebrovascular disease of the central nervous system leading to serious medical complication. It results in a high mortality rate and increased disability rate. Stroke survivors may have long-lasting consequences, including motor dysfunction, sensibility dysfunction, and cognitive impairment]. Cognition is a key component of rehabilitation and recovery; therefore it is associated with poor engagement in rehabilitee and outcomes including increased mortality. As vascular dementia (VaD) is considered the second-most-common type of dementing illness, accounting for a significant proportion of total dementia case, vascular cognitive impairment (VCI) is a broader dimensional term, ranging from mild cognitive impairment without incapacity on activity of daily living to VaD, referred to as significant cognitive impairment and decline in function status.
Acupuncture is an ancient Chinese medical technique in which fine, stainless steel needles are inserted into certain anatomical locations of the body surface to elicit neurohormonal responses of the body system via nerve stimulation. Acupuncture are reported to be probably effective in improving cognitive function in vascular dementia animal models via multiple mechanisms such as anti-apoptosis, antioxidative stress reaction, and metabolism enhancing of glucose and oxygen.
Motor features may not parallel to the cognitive changes, it will serve as the disease progression marker. Unified Parkinson's Disease Rating Scale (UPDRS)-part III scores and NIH Stroke Scale (NIHSS) will be used.
- At Kaohsiung Chang Gung Memorial Hospital, all the patients (n=80) will be included and receive a Standardized Acupuncture intervention; 40 will be treated with regular medication; 40 will be treated with acupuncture and regular medication.
- For acupressure program, all participants are treated in supine position, and a certified TCM physician applied firm pressure (3 to 5 kg of pressure) with fingertips in a circular motion at a speed of 2 circles per second for a duration of one minute per acupoint. The complete process lasts for 8 minutes.
Cognitive function, Motor function, Mood and Sleep will be evaluated at baseline and follow-up period of time at 3 month, 6 month, and 12 month.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Kaohsiung、台湾、83301
- 招聘中
- Kaohsiung Chang Gung Memorial Hospital
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接触：
- YaTing Chang
- 电话号码：077317123
- 邮箱：emily0606@cgmh.org.tw
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1. Fulfill the diagnostic criteria of vascular cognitive impairment
Exclusion Criteria:
- Systemic inflammatory disease with on-going treatment
- Severe psychiatric disease, such as major depressive disorder or schizophrenia
- Severe traumatic brain injury
- Unable to tolerate exam of brain MRI
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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假比较器：regular medication treatment
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acupuncture treatment on selected acupoint
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实验性的：acupuncture and regular medication treatment
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acupuncture treatment on selected acupoint
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline sleep quality at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Analogous variables were extracted from actigraphy.
The sleep variables collected were sleep start time, sleep end time, sleep duration, sleep efficiency, and wake after sleep onset time, and the activity variables collected were heart rate activity score,activity amount, and activity intensity
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3 months, 6 months, 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Cognitive Abilities Screening Instrument (CASI).
In addition to general cognitive performance, CASI was used to evaluate specific domains, including short-term memory, attention and concentration, abstraction, visual construction, language, and list-generating fluency.
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3 months, 6 months, 12 months
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Change from baseline motor function (UPDRS) at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Unified Parkinson's Disease Rating Scale (UPDRS)-part III scores for parkinsonian features.
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3 months, 6 months, 12 months
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Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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NIH Stroke Scale (NIHSS) score 0-24.
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3 months, 6 months, 12 months
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Change from baseline continuous motor function at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Physical activity was measured using accelerometers.
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3 months, 6 months, 12 months
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Change from baseline memory performances at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Verbal memory were evaluated by using Chinese Version Verbal Learning Test (CVVLT).Visual-spatial abilities.
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3 months, 6 months, 12 months
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Change from baseline executive performances at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Attention and executive function was evaluated by Trail Making Test B.
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3 months, 6 months, 12 months
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Change from baseline executive performances (Stroop interference test) at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Attention and executive function was evaluated by Stroop interference test.
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3 months, 6 months, 12 months
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Change from baseline executive performances (calculation) at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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As the calculation ability depends on executive function, calculation ability was evaluated to reflect part of executive function.
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3 months, 6 months, 12 months
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Change from baseline abstract thinking at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Abstract reasoning was evaluated by using similarities (conceptualization) in frontal assessment battery-Similarities.
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3 months, 6 months, 12 months
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Change from baseline language performances at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Boston Naming Test were used to evaluate language ability in naming.
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3 months, 6 months, 12 months
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Change from baseline fluency performances at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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Semantic category fluency.
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3 months, 6 months, 12 months
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Change from baseline neuropsychiatric symptoms at 3 months, 6 months, 12 months
大体时间：3 months, 6 months, 12 months
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The neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory.
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3 months, 6 months, 12 months
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合作者和调查者
调查人员
- 首席研究员：YaTing Chang, MD,PhD、Chang Gung Memorial Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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