A Clinical Trail of Integrative Medicine Approaches for Post-Stroke Cognitive Impairment

Not Applicable

Completed

• Conditions: Post-stroke Cognitive Impairment
• Interventions: Combination Product: Chinese traditional rehabilitation

• Registration Number: NCT04596072
• Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

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.

Study Timeline

• Study Start: 2019-04-25
• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment	Chinese traditional rehabilitation	basic treatment+ Cognitive rehabilitation training+Chinese traditional rehabilitation

Primary Outcome Measures

Name	Time	Method
Change of Cognitive function	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.

Secondary Outcome Measures

Name	Time	Method
Changes in the patterns of activation of brain regions related to cognitive impairment	0 weeks, 8 weeks	ALLF, fALFF, PerAF, ReHo and DC were used to analyze the resting state functional magnetic resonance imaging. The pattern changes of relevant brain regions related to cognitive impairment after stroke were revealed.
change in the scores of mini-Mental State Examination (MMSE)	0 week, 8 weeks, 12 weeks, 16 weeks	The scale is used for rapid evaluation of orientation, memory, attention, calculation, language, and visuospatial structure. MMSE has a maximum score of 30 points. The normal cut-off values are: illiterate group ≥17 points, primary school group ≥20 points, middle school or higher group ≥24 points. Higher scores mean a better outcome.
Changes in Daily Living ability	0 week, 8 weeks, 12 weeks, 16 weeks	ADL(Activity of Daily Living) will be used, which also known as the Barthel Index, consists of 10 items, including toileting, grooming, using the toilet, eating, dressing, transferring, activities, going up and down stairs, and bathing). The total score ranges from 0 to 100. Higher scores mean a better outcome.
Changes in depressive status	0 week, 8 weeks, 12 weeks and 16 weeks	use Hamilton Depression Scale to evaluate depression, the score were 24 for severe, 17 for moderate and 7 for mild. Higher scores mean a worse outcome.

Trial Locations

Locations (3)

The Third Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China

Hangzhou hospital of traditional Chinese medicine; 🇨🇳 Hangzhou, Zhejiang, China

Jiaxing hospital of Chinese traditional medicine; 🇨🇳 Jiaxing, Zhejiang, China