Post-stroke Cognitive ImpairmentNCT04596072
A Clinical Trail of Integrative Medicine Approaches for Post-Stroke Cognitive Impairment
A study testing Chinese traditional rehabilitation in people with Post-stroke Cognitive Impairment, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Cognitive Impairment
- What is being tested?
- Chinese traditional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 3 sitesChina
- Study dates
- 25 Apr 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Hangzhou hospital of traditional Chinese medicine
Hangzhou, Zhejiang, 310002
Jiaxing hospital of Chinese traditional medicine
Jiaxing, Zhejiang, 314000
About this study
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.
Read the 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.
- Conditions
- Post-stroke Cognitive Impairment
- Being tested
- Chinese traditional rehabilitation
- Keywords
- post-stroke cognitive impairment, rehabilitation, traditional Chinese medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese traditional rehabilitationCombination product
Chinese traditional rehabilitation including acupuncture and herbs
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | standard treatment |
| treatment | Experimental | standard treatment, regular cognitive function training, acupuncture, and herbs Receives: Combination Product: Chinese traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 week, 4 weeks, 8 weeks, 12 weeks, 16weeks
Secondary outcomes (4)
change in the scores of mini-Mental State Examination (MMSE)
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.
Measured: 0 week, 8 weeks, 12 weeks, 16 weeks
Changes in Daily Living ability
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.
Measured: 0 week, 8 weeks, 12 weeks, 16 weeks
Changes in depressive status
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.
Measured: 0 week, 8 weeks, 12 weeks and 16 weeks
Changes in the patterns of activation of brain regions related to cognitive impairment
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.
Measured: 0 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start25 Apr 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruijie Ma, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- RUIJIE MA, Doctor, Study director, The Third Affiliated hospital of Zhejiang Chinese Medical UniversityXINYUN LI, Master, Principal investigator, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596072
- Sponsor's protocol ID
- 2020ZJZS002
- Status last verified
- Apr 2025
- First submitted
- 10 Oct 2020
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trail of Integrative Medicine Approaches for Post-Stroke Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04596072
- Acronym / sponsor ID
- 2020ZJZS002
- Conditions
- Post-stroke Cognitive Impairment
- Keywords
- post-stroke cognitive impairment, rehabilitation, traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –standard treatment |
| treatment | Experimental | Combination Product: Chinese traditional rehabilitationstandard treatment, regular cognitive function training, acupuncture, and herbs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese traditional rehabilitationChinese traditional rehabilitation including acupuncture and herbs | Combination product | treatment |
Primary outcome
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.
4 secondary outcomes
change in the scores of mini-Mental State Examination (MMSE)
Time frame: 0 week, 8 weeks, 12 weeks, 16 weeks
Changes in Daily Living ability
Time frame: 0 week, 8 weeks, 12 weeks, 16 weeks
Changes in depressive status
Time frame: 0 week, 8 weeks, 12 weeks and 16 weeks
Changes in the patterns of activation of brain regions related to cognitive impairment
Time frame: 0 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RUIJIE MA, Doctor study director
The Third Affiliated hospital of Zhejiang Chinese Medical University
XINYUN LI, Master principal investigator
Zhejiang Chinese Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese traditional rehabilitation in people with Post-stroke Cognitive Impairment, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Cognitive function (time frame: 0 week, 4 weeks, 8 weeks, 12 weeks, 16weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.