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Post-Stroke Cognitive Impairment (PSCI)NCT07208019

Electroacupuncture Treatment for Post-stroke Cognitive Impairment

A study testing Acupuncture in people with Post-Stroke Cognitive Impairment (PSCI), run by Ruijie Ma at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Post-Stroke Cognitive Impairment (PSCI)
What is being tested?
Acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
340 participants
Where
5 sitesChina
Study dates
5 Oct 2025to 30 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

China5 sites, 5 recruiting
  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    Hangzhou, Zhejiang, 310006

    Fengjia Ni, 19816878056, 873962564@qq.com

    Recruiting
  • Hangzhou Hospital of Traditional Chinese Medicine

    Hangzhou, Zhejiang, 310007

    Liping Li, 13857161334, michelleli2000@163.com

    Not yet recruiting
  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Lusha Tong, 15868171218, rosa00tong@163.com

    Not yet recruiting
  • The Third Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang, 310053

    Kun Yan, +86 28 8542 4855, zslunli@163.com

    Ruijie Ma, +86 18057102851, 20071028@zcmu.edu.cn

    Recruiting
  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 314408

    Xinyun Li, 18069783240, lxyjasmine2010@163.com

    Recruiting

Other trials in China

About this study

Official title: Study on the Key Technology of Acupoint Modulation-based Brain Electric Field Therapy for the Treatment of Post-stroke Cognitive Impairment

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.

Read more

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.

Being tested
Acupuncture
Keywords
Stroke, PSCI, Post-stroke cognitive impairment
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureOther

    Also called Electroacupuncture

    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.

  • AcupunctureOther

    Also called Sham electroacupuncture

    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.

Study groups in NCT07208019
Study groupRoleWhat they receive
Sham electroacupuncture groupSham comparatorTreatment of electroacupuncture device without output current based on ordinary acupuncture and moxibustion
Receives: Other: Acupuncture
Electroacupuncture groupExperimentalTreatment with electro-acupuncture device on the basis of ordinary needling
Receives: Other: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropsychological Test Battery(NTB)

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

  2. Montreal Cognitive Assessment

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

  3. Mini-Mental State Examination

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

Secondary outcomes (8)
  1. Modified Barthel Index

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

  2. 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.

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

  3. 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.

    Measured: Pre-treatment, 8th week post-treatment

  4. Near-infrared spectroscopy

    Measured: Pre-treatment, 8th week post-treatment

  5. Modified Rankin Scale(mRS)

    The scoring criteria are 0-5 points, with 0 being completely asymptomatic and 5 being severely disabled.

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

  6. 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.

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

  7. Magnetic Resonance Imaging

    Measured: Pre-treatment, 8th week post-treatment

  8. 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.

    Measured: Week 8 after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2025
  2. Study start5 Oct 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07208019
Sponsor's protocol ID
2025C02200
Status last verified
Sep 2025
First submitted
9 Sep 2025
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: When all research plans are completed and all participants have completed the clinical study, data access can be opened.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Post-Stroke Cognitive Impairment (PSCI), run by Ruijie Ma at 5 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bowen Chen (+86 13967988987, cbwwjj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuropsychological Test Battery(NTB) (time frame: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment). The study lists 3 primary outcomes in all. 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 17 Dec 2025.

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