An fMRI Study of Jianpi Yishen Huatan Granules for Cognitive Impairment After Acute Cerebral Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Drug: Jianpi Yishen Huatan Granules
* Other: the placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jianpi Yishen Huatan Granules group<br>Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke. | Drug: Jianpi Yishen Huatan Granules<br>* Jianpi Yishen Huatan Granules contain Herba cistanche，Fructus Alpinia Oxyphyllae，Rhodiola rosea, Polygala tenuifolia willd and Coptis chinensis.Jianpi Yishen Huatan Granules dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of treatment cycles: one<br>* Other names: Jianpi Yishen Huatan Granules group;|
| Placebo Comparator: The control group<br>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. | Other: the placebo<br>* Treat with the placebo which contain 5% of prescription of Jian Pi Yi Shen Hua Tan Granules and 95% dextrin.The placebo dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of cycles: one<br>* Other names: the placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the fMRI outcome after the treatment | Using the fMRI to measure the changes of neurotransmitter and brain function in the brain before and after the treatment. | 90 days | 
| Mini-mental state examination(MMSE) | MMSE is an acknowledged scale to measure cognition function from the aspects of orientation ability, memory, attention, calculation ability, recall and language,etc. | 90 days | 
| Montreal Cognitive Assessment scale(MoCA) | Using this scale to measure cognitive function | 90 days | 
| Stroop Color- Word Association Test（Stroop test） | This is a test used to find out the memory and executive function of patients.The test contains three small test. | 90 days | 
| Numerical sequence test（DS-S) | Using Numerical sequence test（DS-S) to examine memory | 90 days | 
| Digital color connection test (CCT) | Using Digital color connection test (CCT) to examine executive function and attention | 90 days | 
| Verbal memory test(HVLT) | Using Verbal memory test(HVLT) to examine verbal memory | 90 days | 
| Clinical Dementia Rating scale(CDR) | Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National institute of health stroke scale | Using National institute of health stroke scale to measure the severity of stroke | 90 days | 
| Modified Rankin scale | Using Modified Rankin scale to measure the recovery of neurological function | 90 days | 
| Activity of Daily Living Scale | Using this scale to measure daily living ability | 90 days | 
| Scores of Chinese medicine symptoms | Scores of Chinese medicine symptoms, which is a scale resulted from literature research, the argumentation of experts and clinical observation,contain 23 items of the core symptoms of cognitive impairment. And the scale is used to measure the changes of symptoms of Chinese medicine before and after treatment. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traditional Chinese medicine granules, Cognitive Impairment, Acute cerebral infraction, treatment