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
Overview
- Phase
- Not Applicable
- Intervention
- Jianpi Yishen Huatan Granules
- Conditions
- Cognitive Impairment
- Sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes of the fMRI outcome after the treatment
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Yunling Zhang
President of Dongfang Hospital
Dongfang Hospital Beijing University of Chinese Medicine
Eligibility Criteria
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
Arms & Interventions
Jianpi Yishen Huatan Granules group
Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke.
Intervention: Jianpi Yishen Huatan Granules
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.
Intervention: the placebo
Outcomes
Primary Outcomes
Changes of the fMRI outcome after the treatment
Time Frame: 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）
Time Frame: 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)
Time Frame: 90 days
Using Numerical sequence test（DS-S) to examine memory
Digital color connection test (CCT)
Time Frame: 90 days
Using Digital color connection test (CCT) to examine executive function and attention
Montreal Cognitive Assessment scale(MoCA)
Time Frame: 90 days
Using this scale to measure cognitive function
Verbal memory test(HVLT)
Time Frame: 90 days
Using Verbal memory test(HVLT) to examine verbal memory
Mini-mental state examination(MMSE)
Time Frame: 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)
Time Frame: 90 days
Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia
Secondary Outcomes
- 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)