An fMRI Study of Jianpi Yishen Huatan Granules for Cognitive Impairment After Acute Cerebral Infarction
- Conditions
- Cognitive Impairment
- Interventions
- Drug: Jianpi Yishen Huatan GranulesOther: the placebo
- Registration Number
- NCT02752867
- Lead Sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Jianpi Yishen Huatan Granules group Jianpi Yishen Huatan Granules Treat with the prescription of Jianpi Yishen Huatan Granules and conventional treatment of ischemic stroke. The control group the placebo 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.
- Primary Outcome Measures
Name Time Method Changes of the fMRI outcome after the treatment 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） 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) 90 days Using Numerical sequence test（DS-S) to examine memory
Digital color connection test (CCT) 90 days Using Digital color connection test (CCT) to examine executive function and attention
Montreal Cognitive Assessment scale(MoCA) 90 days Using this scale to measure cognitive function
Verbal memory test(HVLT) 90 days Using Verbal memory test(HVLT) to examine verbal memory
Mini-mental state examination(MMSE) 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) 90 days Using Clinical Dementia Rating scale(CDR) to measure the severity of dementia
- Secondary Outcome Measures
Name Time Method National institute of health stroke scale 90 days Using National institute of health stroke scale to measure the severity of stroke
Modified Rankin scale 90 days Using Modified Rankin scale to measure the recovery of neurological function
Activity of Daily Living Scale 90 days Using this scale to measure daily living ability
Scores of Chinese medicine symptoms 90 days 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.
Trial Locations
- Locations (1)
Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China