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Clinical Trial NCT07208019 for Post-Stroke Cognitive Impairment (PSCI) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Electroacupuncture Treatment for Post-stroke Cognitive Impairment 340 Non-Invasive Randomized Prevention

Recruiting
Clinical Trial NCT07208019 is an interventional study for Post-Stroke Cognitive Impairment (PSCI) that is recruiting. It started on 5 October 2025 with plans to enroll 340 participants. Led by Ruijie Ma, it is expected to complete by 30 March 2027. The latest data from ClinicalTrials.gov was last updated on 17 December 2025.
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, ...Show More
Official Title

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

Conditions
Post-Stroke Cognitive Impairment (PSCI)
Other Study IDs
  • 2025C02200
NCT ID Number
NCT07208019
Start Date (Actual)
2025-10-05
Last Update Posted
2025-12-17
Completion Date (Estimated)
2027-03-30
Enrollment (Estimated)
340
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Stroke
PSCI
Post-stroke cognitive impairment
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Sham ComparatorSham electroacupuncture group
Treatment of electroacupuncture device without output current based on ordinary acupuncture and moxibustion
Acupuncture
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.
ExperimentalElectroacupuncture group
Treatment with electro-acupuncture device on the basis of ordinary needling
Acupuncture
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 ...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Modified Barthel Index
Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
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.
Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
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.
Pre-treatment, 8th week post-treatment
Near-infrared spectroscopy
Pre-treatment, 8th week post-treatment
Modified Rankin Scale(mRS)
The scoring criteria are 0-5 points, with 0 being completely asymptomatic and 5 being severely disabled.
Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
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.
Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Magnetic Resonance Imaging
Pre-treatment, 8th week post-treatment
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.
Week 8 after treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
35 Years
Eligible Sexes
All
  • 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.

  • 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;
Ruijie Ma logoRuijie Ma
Study Responsible Party
Ruijie Ma, Sponsor-Investigator, Project sponsor, principal investigator, project leader, professor, The Third Affiliated hospital of Zhejiang Chinese Medical University
Study Central Contact
Contact: Bowen Chen, +86 13967988987, [email protected]
Contact: Luyao Fu, +86 18457100195, [email protected]
5 Study Locations in 1 Countries

Zhejiang

Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, 310006, China
Fengjia Ni, Contact, 19816878056, [email protected]
Recruiting
Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, 310007, China
Liping Li, Contact, 13857161334, [email protected]
Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
Lusha Tong, Contact, 15868171218, [email protected]
Not yet recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310053, China
Kun Yan, Contact, +86 28 8542 4855, [email protected]
Ruijie Ma, Contact, +86 18057102851, [email protected]
Recruiting
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 314408, China
Xinyun Li, Contact, 18069783240, [email protected]
Recruiting