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

NCT04596072 | Completed DMC

• 1 other identifier: 2020ZJZS002
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 3

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.

Conditions

Post-stroke Cognitive Impairment

Keywords

post-stroke cognitive impairment; rehabilitation; traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• 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. 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.

  0 week, 4 weeks, 8 weeks, 12 weeks, 16weeks

Secondary Outcomes (4)

• change in the scores of mini-Mental State Examination (MMSE)

  0 week, 8 weeks, 12 weeks, 16 weeks

• Changes in Daily Living ability

  0 week, 8 weeks, 12 weeks, 16 weeks

• Changes in depressive status

  0 week, 8 weeks, 12 weeks and 16 weeks

• Changes in the patterns of activation of brain regions related to cognitive impairment

  0 weeks, 8 weeks

Study Arms (2)

control

NO INTERVENTION

standard treatment

treatment

EXPERIMENTAL

standard treatment, regular cognitive function training, acupuncture, and herbs

Combination Product: Chinese traditional rehabilitation

Interventions

Chinese traditional rehabilitation COMBINATION_PRODUCT

Chinese traditional rehabilitation including acupuncture and herbs

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 17-26. If patient was educated for ≤ 12 years, one score will be deducted;
• HAMD(Hamilton Depression Scale) score \< 20;
• indications for acupuncture and moxibustion techniques.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (3)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location

Hangzhou hospital of traditional Chinese medicine

Hangzhou, Zhejiang, 310002, China

Location

Jiaxing hospital of Chinese traditional medicine

Jiaxing, Zhejiang, 314000, China

Location

Study Officials

• RUIJIE MA, Doctor

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  STUDY DIRECTOR

• XINYUN LI, Master

  Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 22, 2020
• Study Start: April 25, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

CN (3)