Actively Recruiting
Electroacupuncture Treatment for Post-stroke Cognitive Impairment
Led by Ruijie Ma · Updated on 2025-12-17
340
Participants Needed
5
Research Sites
77 weeks
Total Duration
On this page
Sponsors
R
Ruijie Ma
Lead Sponsor
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Electroacupuncture Treatment for Post-stroke Cognitive Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with vascular cognitive impairment after stroke according to Chinese Western medicine guidelines
- Meet traditional Chinese medicine criteria for vascular mild cognitive impairment
- Mini Mental State Examination (MMSE) score between 12 and 24
- Montreal Cognitive Assessment (MoCA) score below 24
- National Institutes of Health Stroke Scale (NIHSS) score of 8 or less
- Early Dementia Screening Scale (AD-8) score less than 2
- Aged between 35 and 80 years old
- Basic communication skills in Mandarin and have at least one stable caregiver
- Signed informed consent form
You will not qualify if you...
- Serious primary chronic diseases such as heart, liver, kidney, endocrine, or blood system diseases
- Severe cardiovascular or cerebrovascular diseases
- Skin diseases or scar conditions unsuitable for acupuncture
- Unable to undergo repeated MRI exams due to claustrophobia or implants
- Cognitive impairment or severe neurological or mental disorders before stroke with unstable control
- Deemed unsuitable for the study by clinical trial staff
- Participated in related clinical research within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
2
Hangzhou Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China, 310007
Not Yet Recruiting
3
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
4
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310053
Actively Recruiting
5
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 314408
Actively Recruiting
Research Team
B
Bowen Chen
CONTACT
L
Luyao Fu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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