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| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| The Third Affiliated hospital of Zhejiang Chinese Medical University | OTHER |
| The First Affiliated Hospital of Zhejiang Chinese Medical University |
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Stroke is a global public health issue, and it has become a leading cause of death and disability in China. With the rapid aging of the Chinese population, its incidence rate is continuously rising. According to the "China Stroke Prevention and Treatment Report (2023)", on average, one person experiences a new or recurrent stroke every 10 seconds in China, and one person dies from stroke every 28 seconds. Currently, there are 4 million new stroke cases in China each year, with 12.42 million individuals aged 40 and above currently suffering from stroke, and the affected population is showing a trend of younger onset. Among survivors, approximately 75% suffer from residual disabilities, and 40% have severe disabilities. Consequently, patient families will experience significant economic losses and physical and psychological pain.
Post-Stroke Cognitive Impairment (PSCI) is a common complication of stroke, where patients develop cognitive impairment within six months after the stroke event that meets the diagnostic criteria for cognitive impairment. PSCI is defined as a clinical phenomenon secondary to stroke events, with cognitive decline as its core characteristic. Such impairments encompass cognitive dysfunction caused by various stroke types and are one of the main determinants of functional dependency in post-stroke survivors. The prevalence of PSCI within six months is approximately 30% to 50%, with 10% progressing to dementia. Additionally, PSCI patients face a high risk of death, with up to 61% dying within five years. Countries worldwide have launched targeted guidelines, calling for increased attention and investment in this major complication. However, current treatments for PSCI are still limited to secondary prevention measures for stroke and drugs for treating Alzheimer's disease-like conditions, all lacking high-level clinical evidence. Therefore, effective treatments are urgently needed to improve patient outcomes.
PSCI is a dynamically evolving process, with individual differences in its occurrence time, influencing factors, clinical manifestations, and recovery prognosis. The unique diagnostic system of traditional Chinese medicine may assist in analyzing the disease progression of PSCI. The study of the patterns of syndrome evolution can help explain and provide reference for treatment. Currently, there are no specific drugs for treating PSCI, and relevant drug treatments lack high-level evidence. In recent years, with the development of imaging, artificial intelligence, and electromagnetic physics, non-pharmacological therapies have gradually become one of the research hotspots in the field of PSCI. It is worth noting that non-invasive brain stimulation, represented by transcranial electrical stimulation, is a therapy that directly acts on the brain lesions of PSCI and is often used in combination with acupoint stimulation to achieve better therapeutic effects. Meanwhile, acupuncture and moxibustion therapy has demonstrated good efficacy and safety in the prevention and treatment of PSCI. Multiple clinical studies suggest that electroacupuncture therapy can improve cognitive impairment in patients with PSCI and enhance their quality of life. Furthermore, electroacupuncture therapy can also provide targeted treatment for patients through syndrome differentiation and treatment, compensating for the limitations of Western medicine drug therapy.
This study aims to investigate the evolution patterns of syndromes in post-stroke cognitive impairment (PSCI). Simultaneously, through the standardization of multidimensional and multimodal data related to PSCI patients, we will conduct a multicenter, large-sample clinical randomized controlled trial of electroacupuncture intervention for PSCI using a multimodal artificial intelligence big data model. The goal is to establish a characteristic technology for the diagnosis and treatment of PSCI in traditional Chinese medicine (TCM) that is suitable for promotion, and to establish clinical diagnosis and treatment pathways and standard specifications for diseases where TCM has advantages. This will facilitate the establishment of an efficacy evaluation system for PSCI based on TCM syndrome diagnosis and evolution patterns, realize a precise diagnosis and treatment model combining traditional Chinese and Western medicine for PSCI, and improve patients' overall efficacy and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham electroacupuncture group | Sham Comparator | Treatment of electroacupuncture device without output current based on ordinary acupuncture and moxibustion |
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| Electroacupuncture group | Experimental | Treatment with electro-acupuncture device on the basis of ordinary needling |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Electroacupuncture group: After local routine disinfection.Select the main acupoints of bilateral frontoparietal line (MS2), Tianzhu (BL10), Fengchi (GB20), blood supply, parietal midline (MS5), and parietal midline (MS8). Connect the wires of the electroacupuncture instrument to the same side of the bilateral frontoparietal line(MS2) and Tianzhu acupoint (BL10), and perform head electroacupuncture treatment on both sides with a pair on each side.There are two groups of electroacupuncture, with a continuous frequency of 100Hz, and each electroacupuncture stimulation lasts for 30 minutes. After enrollment, treatment will be conducted 5 times a week for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological Test Battery(NTB) | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment | |
| Montreal Cognitive Assessment | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment | |
| Mini-Mental State Examination | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Barthel Index | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment | |
| Hamilton Depression Scale(HAMD) | <7 indicates no, 7-17 indicates possible, 17-24 indicates certain,>24 indicates severe depression. The lowest score is 0, and the highest score is 46. The higher the score, the more severe the patient's depression. |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bowen Chen | Contact | +86 13967988987 | cbwwjj@163.com | |
| Luyao Fu | Contact | +86 18457100195 | 1710591584@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruijie Ma | The Third Affiliated hospital of Zhejiang Chinese Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial Hospital of Traditional Chinese Medicine | Recruiting | Hangzhou | Zhejiang | 310006 | China |
When all research plans are completed and all participants have completed the clinical study, data access can be opened.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2025 | Dec 9, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 25, 2025 | Sep 9, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| D004599 | Electric Stimulation Therapy |
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| Hangzhou Hospital of Traditional Chinese Medicine | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
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In the whole research process the principle of three separations was implemented: the three parties of operators efficacy evaluators and statistical analysts were separated and the three parties could not exchange research data implementation and other related contents during the whole process of the study. That is to say the third-party professional statisticians who did not know the grouping situation carried out the efficacy evaluation and statistical analysis of the result data in order to try to avoid the bias of the data results caused by single blinding.
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| Acupuncture | Other | Sham electroacupuncture group: After local routine disinfection. Choose the same acupoints as the electroacupuncture group, but use a specially designed electroacupuncture instrument that cannot output current, with only indicator lights or parameter displays when in use. |
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| Week 0 before treatment, Week 12 after treatment, Week 24 after treatment |
| Electroencephalogram(EEG) | Evaluate the quantitative electroencephalogram parameters alpha wave, beta wave, delta wave, and theta wave absolute power, as well as the (delta+theta)/(alpha+beta) ratio (DTABR) and delta/alpha power ratio (DAR), and analyze the correlation between various parameters and cognitive function. | Pre-treatment, 8th week post-treatment |
| Near-infrared spectroscopy | Pre-treatment, 8th week post-treatment |
| Modified Rankin Scale(mRS) | The scoring criteria are 0-5 points, with 0 being completely asymptomatic and 5 being severely disabled. | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment |
| Pittsburgh sleep quality index(PSQI) | It consists of seven dimensions: subjective sleep quality, falling asleep time, sleep duration, sleep disturbances, use of hypnotic drugs, daytime functional disorders, and sleep efficiency. Each dimension scores 0-3 points, with a minimum score of 0 and a maximum score of 21 points. The higher the score, the more severe the sleep problem. The total score of the seven dimensions is the PSQI score. | Week 0 before treatment, Week 12 after treatment, Week 24 after treatment |
| Magnetic Resonance Imaging | Pre-treatment, 8th week post-treatment |
| Short Form 12 Health Survey(SF-12) | This scale covers eight aspects: physical function, physical role, pain, general health, mental health, social function, emotional role, and psychological health. The overall score range is 0-100 points, with higher scores indicating better health conditions. | Week 8 after treatment |
| Hangzhou Hospital of Traditional Chinese Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310007 | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
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| The Third Affiliated Hospital of Zhejiang Chinese Medical University | Recruiting | Hangzhou | Zhejiang | 310053 | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 314408 | China |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |