Clinical trial NCT04596072: A Clinical Trail of Integrative Medicine Approaches for Post-Stroke Cognitive Impairment
Official title: A Clinical Trail of Integrative Medicine Approaches for Post-Stroke Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Cognitive Impairment
Keywords: post-stroke cognitive impairment
rehabilitation
traditional Chinese medicine
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. age above 18 years;
3. disease duration of 30-180 days;
4. written informed consent by the patient's legal guardian;
5. MoCA (Montreal Cognitive Assessment) score of 17-26. If patient was educated for ≤ 12 years, one score will be deducted;
6. HAMD(Hamilton Depression Scale) score \< 20;
7. indications for acupuncture and moxibustion techniques.

Exclusion Criteria:

1. 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;
2. non-atherosclerotic thrombotic cerebral infarction (such as cardiac embolism, procoagulant state, endovascular shedding, or arteritis);
3. pregnant or lactating women;
4. severe chronic diseases of the heart, liver, kidneys, other viscera, or endocrine system or hematopoietic system;
5. severe dementia, serious language understanding disorders, or mental illness;
6. bleeding tendency;
7. lack of inclusion criteria or not suitable for clinical observation.

Primary outcomes:
measure: Change of Cognitive function
timeFrame: 0 week, 4 weeks, 8 weeks, 12 weeks, 16weeks
Secondary outcomes:
measure: change in the scores of mini-Mental State Examination (MMSE)
timeFrame: 0 week, 8 weeks, 12 weeks, 16 weeks
measure: Changes in Daily Living ability
timeFrame: 0 week, 8 weeks, 12 weeks, 16 weeks
measure: Changes in depressive status
timeFrame: 0 week, 8 weeks, 12 weeks and 16 weeks
measure: Changes in the patterns of activation of brain regions related to cognitive impairment
timeFrame: 0 weeks, 8 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou hospital of traditional Chinese medicine
state: Zhejiang
city: Jiaxing
country: China
facility: Jiaxing hospital of Chinese traditional medicine
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: RUIJIE MA, Doctor
role: STUDY_DIRECTOR
affiliation: Zhejiang Chinese Medical University
name: XINYUN LI, Master
role: PRINCIPAL_INVESTIGATOR
References: