Functional Magnetic Resonance Imaging Study to Explore the Mechanism and the Efficacy and Safety of Jianpi Yishen Huatan Granule for Cognitive Impairment After Acute Cerebral Infarction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes of the fMRI outcome after the treatment
研究概览
简要总结
The purpose of this study is to explore the pathogenesis of cognitive impairment after acute cerebral infarction by applying the multimodal function MRI to dynamically observe the changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of the brain ,and to provide a visual instrument for evaluating the therapeutical effects of Chinese medicine through the application of multimodal function MRI to observe the changes of the neurotransmitter in certain area in the brain before and after the treatment.
详细描述
The present study is designed to assess the efficacy and safety of Jianpi Yishen Huatan granules with cognitive impairment after Acute Cerebral Infarction by fMRI and neuropsychology scales,as well as observe the symptoms,syndrome characteristics and neuropsychological changes of patients with cognitive dysfunction after acute cerebral infarction.And explore the pathogenesis of cognitive impairment after acute cerebral infarction by applying the multimodal function MRI to dynamically observe the changes of the value of NAA,Cho,Cr,FA in a certain region in the brain and the function of the brain ,and to provide a visual instrument for evaluating the therapeutical effects of Chinese medicine through the application of multimodal function MRI to observe the changes of the neurotransmitter in certain area in the brain before and after the treatment.
The sample size is 40 of which 20 are from the intervention group and 20 are from the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients conform to the diagnostic criteria of acute ischemic stroke.
- •The cerebral infarction area lies in the blood supply area of middle cerebral artery: basal ganglia,corona radiate region or other subcortical regions..
- •The cumulative infarction area is no more than 3.0 cm.
- •Stroke onset within 21 days
- •Age from forty to eighty, gender not limited
- •Neuropsychological assessments: Montreal Cognitive Assessment Scale scores less than 26 points or MMSE scores range from 19 points to 26 points in literates or MMSE scores range from 17 points to 24 points in illiterates
- •Informed and signed the informed consent
排除标准
- •Transient Ischemic Attack
- •Stroke patients with the causes of cerebral hemorrhage, subarachnoid hemorrhage, brain tumors, brain injury, or blood diseases and so on.
- •Stroke with an onset of more than 21 days
- •Cerebral embolism caused by atrial fibrillation resulted from rheumatic heart disease, coronary heart disease and other heart diseases.
- •Patients who cannot cooperate with the check due to serious visual, hearing dysfunction, apraxia, aphasia.
- •Patients with other neurological diseases which can affect cognitive function (for example:Alzheimer's Disease，Parkinson's disease, frontotemporal dementia，Huntington's disease)
- •Patients with communication difficulties, or psychiatric disease
- •Depression (Hamilton Depression Scale scores more than or equal to 17 points)
- •Diagnosed with alcohol or drug dependence within the past six months
- •With other diseases which can cause cognitive dysfunction, Such as trauma，tumor or infection of the central nervous system, metabolic disorders, normal pressure hydrocephalus , folic acid or vitamin B12 Deficiency, thyroid hypofunction,sever anemia,sever Parkinson's Disease, encephalitis, syphilis or HIV
- •With a previous history of stroke and serious sequelae, and cannot cope with neuropsychological examination
- •With severe primary diseases, and cannot comply with the above scheme
研究组 & 干预措施
Jianpi Yishen Huatan Granules group
Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.
干预措施: Jianpi Yishen Huatan Granules (Drug)
The control group
Treat with the placebo which contain 5% of prescription of Jian Pi Yi Shen Hua Tan Granules and 95% dextrin and conventional treatment of ischemic stroke.
干预措施: the placebo (Other)
结局指标
主要结局
Changes of the fMRI outcome after the treatment
时间窗: 90 days
Using the fMRI to measure the changes of neurotransmitter and brain function in the brain before and after the treatment.
Stroop Color- Word Association Test（Stroop test）
时间窗: 90 days
This is a test used to find out the memory and executive function of patients.The test contains three small test.
Numerical sequence test（DS-S)
时间窗: 90 days
Using Numerical sequence test（DS-S) to examine memory
Digital color connection test (CCT)
时间窗: 90 days
Using Digital color connection test (CCT) to examine executive function and attention
Montreal Cognitive Assessment scale(MoCA)
时间窗: 90 days
Using this scale to measure cognitive function
Verbal memory test(HVLT)
时间窗: 90 days
Using Verbal memory test(HVLT) to examine verbal memory
Mini-mental state examination(MMSE)
时间窗: 90 days
MMSE is an acknowledged scale to measure cognition function from the aspects of orientation ability, memory, attention, calculation ability, recall and language,etc.
Clinical Dementia Rating scale(CDR)
时间窗: 90 days
Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia
次要结局
- National institute of health stroke scale(90 days)
- Modified Rankin scale(90 days)
- Activity of Daily Living Scale(90 days)
- Scores of Chinese medicine symptoms(90 days)
研究者
Yunling Zhang
President of Dongfang Hospital
Dongfang Hospital Beijing University of Chinese Medicine