A Clinical Trail of Acupuncture and Herbs for Post-stroke Cogntive Impairment

Study Overview
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Brief Summary
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The traditional Chinese medicine rehabilitation for the post-stroke cognitive impairment will be intervened, which can promote the recovery of post-stroke cognitive function patients, reduce the disability rate and improve the quality of life.

Detailed Description
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This study will collect inpatients from April 2020 to December 2022 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.

Official Title
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A Clinical Trail of Acupuncture and Herbs for Post-stroke Cogntive Impairment

Conditions
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Post-stroke Cognitive Impairment

Intervention / Treatment
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* Combination Product: Chinese traditional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Cognitive disorder Chinese medicine diagnosed as apoplexy; The diagnosis of cerebral infarction or cerebral hemorrhage was consistent with western medicine by CT/MRI examination; The course of disease ranges from 30 to 180 days; First onset; Or come on in the past without the sequela such as limb paralysis; ·Age ≥18 years; Informed consent signed by the legal guardian of the patient; Montreal cognitive assessment scale (Montreal Cognitive Assessment, MoCA) score reaches a certain standard, MoCA scale score of 30 points, scored 17-26 points or less judged with cognitive impairment, if the education time 12 years or less on the basis of plus 1; Hamilton depression scale (HAMD) < 20. Meet the requirements of indications of acupuncture and moxibustion; Volunteer to participate in this project, the patient has no serious complications, can accept acupuncture treatment and good compliance. Exclusion Criteria: Cognitive disorder Subarachnoid hemorrhage, transient ischemic attack, or with other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cysticercosis, schistosomiasis, encephalitis, meningitis, hydrocephalus, brain trauma sequelae; ·Non-atherosclerotic thrombotic cerebral infarction (such as cardiogenic embolism, clotting status, endovascular shedding, arteritis, etc.); Patients with severe primary chronic diseases such as heart, liver, kidney, viscera, endocrine system, hematopoietic system, serious disorders of language understanding, and mental disorders; Suffered from a variety of bleeding tendency diseases; Pregnant or lactating women; Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, which cannot judge the efficacy or incomplete data affect the efficacy judgment and are not suitable for clinical observation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| No Intervention: control<br>basic treatment+ Cognitive rehabilitation training | |
| Experimental: treatment<br>basic treatment+ Cognitive rehabilitation training+Chinese traditional rehabilitation | Combination Product: Chinese traditional rehabilitation<br>* Chinese traditional rehabilitation including acupuncture and herbs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Cognitive function | Montreal Cognitive Assessment(MOCA) will be used,this method focus on the sensitivity and specificity of the scale for the recognition of cognitive impairment are high, and it is evaluated from visual spatial/executive function, language function, image ability orientation and so on. | baseline, 0 week, 8 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Daily Living ability | The scale has a total of 14 items, including two parts: one is the physical life self-care scale, with 6 items (going to the toilet, eating, dressing, grooming, walking and bathing); The second is the instrumental daily living ability scale, which consists of 8 items (telephone, shopping, meal preparation, housework, laundry, transportation, medication and self-care economy). | 0 week, 12 weeks, 16 weeks and 24 weeks | 
| Changes in depressive status | use Hamilton Depression Scale to evaluate depression，the score were 24 for severe, 17 for moderate and 7 for mild. | 0 week, 12 weeks, 16 weeks and 24 weeks | 
| Montreal cognitive assessment scale score change trend | analyse the change scale scores of different stages(Before intervention；After 8 weeks 、16 weeks 、24 weeks intervention) MOCA, the higher scores mean a better outcome | at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks | 
| Changes in memory, attention and computational ability, language function | use MOCA to evaluate Memory, attention and calculation ability, language function | at baseline, 12weeks | 
| The rate of change in the scores of mini-Mental State Examination (MMSE) | analyse the change scale score of before intervention MMSE, higher scores mean a better outcome | at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks | 
| Neural activity in the brain | The changes of the concentration of oxy-hemoglobin(HbO2), deoxy-hemoglobin (Hbb), cerebral blood flow (CBF) and cerebral blood volume of Functional near-infrared spectroscopy(fNIRS) will be analyzed | at baseline and 12 weeks | 
| Changes in the patterns of related brain regions in cognitive impairment | use re-fMRI data of ALLF，ReHo，FC to evaluate brain function | at baseline and 12 weeks | 
| Effective rate of cognitive function treatment | MoCA score will be calculated from baseline to 12 weeks of treatment and effective rate of treatment will follow the specific criteria. Recovery: the score increased by ≥90% compared with the baseline; Significant effective: the score increased between 70% and 89% compared with the baseline. Effective: the score increased between 30% and 69% compared with the baseline. Ineffective: the score increased < 30% compared with the baseline | at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks | 
| Changes in the neurologic recovery | The Rankim Scale will be analyzed at baseline，0 week, 12 weeks to assess the changes in the neurologic recovery. | at baseline，0 week, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, post-stroke cognitive impairment, traditional Chinese medicine