Electroacupuncture Treatment for Post-stroke Cognitive Impairment

Ruijie Ma

Status: Enrolling

Conditions: Post-Stroke Cognitive Impairment (PSCI)

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07208019

2025C02200

Details and patient eligibility

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• According to the Western diagnostic criteria for vascular cognitive impairment outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Vascular Cognitive Impairment (2024 Edition)" developed by the Vascular Cognitive Impairment Branch of the Chinese Stroke Society.
• Meets the traditional Chinese medicine diagnostic criteria for vascular cognitive impairment in the "Guidelines for Traditional Chinese Medicine Diagnosis and Treatment of Vascular Mild Cognitive Impairment (2024)";
• The Mini Mental State Examination (MMSE) score ranges from 12-24, while the Montreal Cognitive Assessment (MoCA) score is below 24; Having cognitive impairment but not reaching the level of severe dementia; The National Institutes of Health Stroke Scale (NIHSS) score is ≤ 8 points; The Early Dementia Screening Scale (Ascertain Dementia 8, AD-8) score is less than 2 points;
• Age between 35-80 years old;
• Have basic communication skills, with Mandarin as the main language (communication language is sufficient), and have at least one stable caregiver;
• Sign the informed consent form.

Exclusion criteria

• Merge serious primary chronic diseases such as heart, liver, kidney, endocrine system, and hematopoietic system, as well as severe cardiovascular and cerebrovascular diseases;
• Skin diseases or scar constitution such as herpes and ulceration are easy to appear on the body surface, which is not suitable for acupuncture and moxibustion treatment;
• Not suitable for repetitive MRI examinations, such as claustrophobia, arterial aneurysm embolization, etc;
• Patients with cognitive impairment or other severe neurological or mental disorders prior to the onset of this illness, and unstable control;
• Patients identified by other clinical trial personnel as unsuitable for this study;
• Participated in clinical research on related diseases in the past 3 months;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 2 patient groups

Sham electroacupuncture group

Sham Comparator group

Description:

Treatment of electroacupuncture device without output current based on ordinary acupuncture and moxibustion

Treatment:

Other: Acupuncture

Other: Acupuncture

Electroacupuncture group

Experimental group

Description:

Treatment with electro-acupuncture device on the basis of ordinary needling

Treatment:

Other: Acupuncture

Other: Acupuncture