Electroacupuncture Treatment for Post-stroke Cognitive Impairment

NCT07208019 | Recruiting DMC

• 1 other identifier: 2025C02200
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 5

Brief Summary

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

Post-Stroke Cognitive Impairment (PSCI)

Keywords

Stroke; PSCI; Post-stroke cognitive impairment

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• Modified Barthel Index

  Week 0 before treatment, Week 12 after treatment, Week 24 after treatment

• Hamilton Depression Scale(HAMD)

  Week 0 before treatment, Week 12 after treatment, Week 24 after treatment

• Electroencephalogram(EEG)

  Pre-treatment, 8th week post-treatment

• Near-infrared spectroscopy

  Pre-treatment, 8th week post-treatment

• Modified Rankin Scale(mRS)

  Week 0 before treatment, Week 12 after treatment, Week 24 after treatment

Study Arms (2)

Sham electroacupuncture group

SHAM COMPARATOR

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

Other: Acupuncture

Electroacupuncture group

EXPERIMENTAL

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

Other: Acupuncture

Interventions

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.

Also known as: Electroacupuncture

Electroacupuncture group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ruijie Ma: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• The Third Affiliated hospital of Zhejiang Chinese Medical University: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Hangzhou Hospital of Traditional Chinese Medicine: collaborator
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (5)

Zhejiang Provincial Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, 310006, China

RECRUITING

Hangzhou Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, 310007, China

NOT YET RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 314408, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Acupuncture Therapy; Electroacupuncture

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Ruijie Ma

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bowen Chen

CONTACT

+86 13967988987; cbwwjj@163.com

Luyao Fu

CONTACT

+86 18457100195; 1710591584@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project sponsor, principal investigator, project leader, professor

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: October 6, 2025
• Study Start: October 5, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-09

Locations

CN (5)