Electroacupuncture for cognitive problems after stroke
Study on the Key Technology of Acupoint Modulation-based Brain Electric Field Therapy for the Treatment of Post-stroke Cognitive Impairment
This trial will test whether electroacupuncture can improve thinking and memory in people who developed cognitive problems after a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University Academic / other |
| Locations | 5 sites (Hangzhou, Zhejiang and 4 other locations) |
| Trial ID | NCT07208019 on ClinicalTrials.gov |
What this trial studies
This interventional trial enrolls adults 35–80 with vascular post-stroke cognitive impairment (meeting Chinese diagnostic guidelines, MMSE 12–24, MoCA <24, NIHSS ≤8) across three hospitals in Hangzhou, China. Participants receive standardized electroacupuncture delivered by trained practitioners at Traditional Chinese Medicine and university hospitals. Cognitive function and related measures (for example MMSE, MoCA, AD-8, and NIHSS) are recorded before and after the intervention to track changes in thinking, memory, and daily function. The trial compares participants' cognitive outcomes following the electroacupuncture regimen to baseline and/or usual care to determine clinical effects.
Who should consider this trial
Good fit: Ideal candidates are Mandarin-speaking adults aged 35–80 with vascular post-stroke cognitive impairment per Chinese guidelines, MMSE 12–24, MoCA <24, NIHSS ≤8, and basic communication ability.
Not a fit: Patients with severe dementia, major residual stroke deficits beyond the trial's NIHSS cutoff, nonvascular causes of cognitive decline, or those unable to attend regular clinic-based acupuncture sessions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, electroacupuncture could provide a non-drug option to improve cognition and daily functioning for people with post-stroke cognitive impairment.
How similar studies have performed: Previous acupuncture and electroacupuncture trials for post-stroke cognitive impairment have shown mixed results, with some small trials suggesting modest benefits but overall evidence remaining limited and heterogeneous.
Eligibility criteria
Show full inclusion / 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;
Where this trial is running
Hangzhou, Zhejiang and 4 other locations
- Zhejiang Provincial Hospital of Traditional Chinese Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Hangzhou Hospital of Traditional Chinese Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Ruijie Ma — The Third Affiliated hospital of Zhejiang Chinese Medical University
- Study coordinator: Bowen Chen
- Email: cbwwjj@163.com
- Phone: +86 13967988987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.