Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline sleep quality at 3 months, 6 months, 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill the diagnostic criteria of vascular cognitive impairment
排除标准
- •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
研究组 & 干预措施
regular medication treatment
regular medication treatment
干预措施: Acupuncture (Device)
acupuncture and regular medication treatment
acupuncture and regular medication treatment
干预措施: Acupuncture (Device)
结局指标
主要结局
Change from baseline sleep quality at 3 months, 6 months, 12 months
时间窗: 3 months, 6 months, 12 months
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
次要结局
- Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline motor function (UPDRS) at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline continuous motor function at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline memory performances at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline executive performances at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline executive performances (Stroop interference test) at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline executive performances (calculation) at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline abstract thinking at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline language performances at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline fluency performances at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)
- Change from baseline neuropsychiatric symptoms at 3 months, 6 months, 12 months(3 months, 6 months, 12 months)