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NCT Number: NCT04596072

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

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.

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Key information

Conditions

Post-stroke Cognitive Impairment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou hospital of traditional Chinese medicine, Hangzhou, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Chinese traditional rehabilitation

Combination Product

Chinese traditional rehabilitation including acupuncture and herbs

Primary outcomes

  1. Change of Cognitive function

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Changes in Daily Living ability

    Time frame: 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.

  3. Changes in depressive status

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2020
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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