A Clinical Trail of Integrative Medicine Approaches for Post-Stroke Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 3
- 主要终点
- Change of Cognitive function
研究概览
简要总结
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.
详细描述
This study will collect inpatients from April 2019 to December 2024 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke as per the TCM definition, presenting symptoms include unilateral paresis or paralysis, sensory deficits, speech impairment, and hemianopsia. PSCI diagnosis involves clinically significant deficits in at least one cognitive domain and severe disruption of instrumental activity of daily livings.
- •age above 18 years;
- •disease duration of 30-180 days;
- •written informed consent by the patient's legal guardian;
- •MoCA (Montreal Cognitive Assessment) score of 17-
- •If patient was educated for ≤ 12 years, one score will be deducted;
- •HAMD(Hamilton Depression Scale) score < 20;
- •indications for acupuncture and moxibustion techniques.
排除标准
- •Cognitive impairment caused by subarachnoid hemorrhage, transient ischemic attack, or other intracranial lesions., such as tumors, aneurysms, vascular malformations, cysticercosis, schistosomiasis, encephalitis, meningitis, hydrocephalus, or head trauma;
- •non-atherosclerotic thrombotic cerebral infarction (such as cardiac embolism, procoagulant state, endovascular shedding, or arteritis);
- •pregnant or lactating women;
- •severe chronic diseases of the heart, liver, kidneys, other viscera, or endocrine system or hematopoietic system;
- •severe dementia, serious language understanding disorders, or mental illness;
- •bleeding tendency;
- •lack of inclusion criteria or not suitable for clinical observation.
结局指标
主要结局
Change of Cognitive function
时间窗: 0 week, 4 weeks, 8 weeks, 12 weeks, 16weeks
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. MoCA has a maximum score of 30 points. The normal scoring standard is a total score ≥ 26 points (for those with an education level ≤ 12 years, this standard is reduced by 1 point). Higher scores mean a better outcome.
次要结局
- Changes in the patterns of activation of brain regions related to cognitive impairment(0 weeks, 8 weeks)
- Changes in Daily Living ability(0 week, 8 weeks, 12 weeks, 16 weeks)
- change in the scores of mini-Mental State Examination (MMSE)(0 week, 8 weeks, 12 weeks, 16 weeks)
- Changes in depressive status(0 week, 8 weeks, 12 weeks and 16 weeks)
研究者
Ruijie Ma
Clinical Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University