Clinical trial NCT02752867: An fMRI Study of Jianpi Yishen Huatan Granules for Cognitive Impairment After Acute Cerebral Infarction
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Keywords: traditional Chinese medicine granules
Cognitive Impairment
Acute cerebral infraction
treatment
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Changes of the fMRI outcome after the treatment
timeFrame: 90 days
measure: Mini-mental state examination(MMSE)
timeFrame: 90 days
measure: Montreal Cognitive Assessment scale(MoCA)
timeFrame: 90 days
measure: Stroop Color- Word Association Test（Stroop test）
timeFrame: 90 days
measure: Numerical sequence test（DS-S)
timeFrame: 90 days
measure: Digital color connection test (CCT)
timeFrame: 90 days
measure: Verbal memory test(HVLT)
timeFrame: 90 days
measure: Clinical Dementia Rating scale(CDR)
timeFrame: 90 days
Secondary outcomes:
measure: National institute of health stroke scale
timeFrame: 90 days
measure: Modified Rankin scale
timeFrame: 90 days
measure: Activity of Daily Living Scale
timeFrame: 90 days
measure: Scores of Chinese medicine symptoms
timeFrame: 90 days
Other outcomes:
measure: whole blood cell test
timeFrame: 90 days
measure: routine urine test
timeFrame: 90 days
measure: Liver function
timeFrame: 90 days
measure: electrocardiogram
timeFrame: 90 days
measure: homocysteine
timeFrame: 90 days
measure: routine stool test
timeFrame: 90 days
measure: kidney function
timeFrame: 90 days
Locations:
city: Beijing
country: China
facility: Department of Neurology,Dongfang Hospital,Beijing University of Chinese Medicine
state: Beijing
Study officials:
affiliation: Dongfang Hospital Beijing University of Chinese Medicine
name: Yunling Zhang
role: STUDY_CHAIR
References: