An interventional study of True Electroacupuncture and Sham Electroacupuncture in Post-Stroke Cognitive Impairment, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
This clinical study investigates whether electroacupuncture can improve thinking and memory in people with cognitive problems after a stroke (Post-Stroke Cognitive Impairment, or PSCI).
Participants will be randomly assigned to one of two groups: one group will receive real electroacupuncture, while the other will receive a sham treatment . Both groups will also receive standard medical care.The main goal is to see if the real electroacupuncture leads to greater improvement in cognitive function tests over 6 months compared to the sham treatment. The study will also use brain scans (MRI) and other assessments to understand how the treatment might work.
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: True Electroacupuncture
Procedure: Sham Electroacupuncture
The true electroacupuncture group will receive electroacupuncture treatment for 7 days, once a day, each session lasting approximately 30 minutes. Acupoints include main points (e.g., bilateral forehead lines, Tianzhu BL10, Fengchi GB20) and syndrome-based points. After needle insertion and manual stimulation for deqi, true EA (100 Hz dense wave, tolerable intensity) is applied the SDZ-IIB device, connecting MS2 and BL10 on each side.
The sham electroacupuncture group will receive electroacupuncture treatment for 7 days, once a day, each session lasting approximately 30 minutes.The same acupoints and needle insertion/manual stimulation are used. However, a modified SDZ-IIB device with severed leads (incapable of current output) is connected, simulating the appearance of true electroacupuncture without electrical stimulation. The treatment frequency and duration are identical to the electroacupuncture group.
Change in Mini-Mental State Examination (MMSE) Score
The Mini-Mental State Examination (MMSE) is a standardized 30-point questionnaire used to screen for cognitive impairment. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame: baseline, 3 months and 6 months post-treatment.
Change in MoCA (Montreal Cognitive Assessment) Scale Score
The Montreal Cognitive Assessment (MoCA) is a 30-point screening tool designed to detect mild cognitive impairment. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame: baseline, 3 months and 6 months post-treatment.
Change in Clinical Dementia Rating (CDR) scale Score
The Clinical Dementia Rating (CDR) is a clinician-rated scale that assesses the severity of dementia across six domains. The global CDR score ranges from 0 (no impairment) to 3 (severe dementia), with higher scores indicating greater severity of dementia.
Time frame: baseline, 3 months and 6 months post-treatment.
Change in NTB (Neuropsychological Test Battery) Score
The Neuropsychological Test Battery (NTB) is a composite measure designed to assess cognitive function across multiple domains. It evaluates key areas including memory (e.g., verbal/visual recall), attention, executive function, and processing speed. A composite Z-score is derived by averaging the standardized scores of the individual cognitive tests. The composite score is interpreted such that higher scores indicate better overall cognitive performance.
Time frame: baseline, 3 months and 6 months post-treatment.
Multimodal functional Near-Infrared Spectroscopy - Electroencephalogram (fNIRS-EEG) Assessment
Functional Near-Infrared Spectroscopy (fNIRS) and Electroencephalogram (EEG) are used to non-invasively record cerebral hemodynamic changes (blood oxygen levels and blood flow) and electrophysiological brain activity, respectively, to explore neural correlates of treatment response.
Time frame: baseline, 3 months, and 6 month
Quality of Life as assessed by the Stroke-Specific Quality of Life Scale (SS-QOL)
The Stroke-Specific Quality of Life Scale (SS-QOL) is a patient-reported outcome measure designed to evaluate health-related quality of life specifically for stroke survivors. It assesses multiple domains relevant to life after stroke. Scores are calculated for each domain and a total score can be derived, with higher scores indicating better perceived quality of life.
Time frame: baseline, 3 months, and 6 months.
Depressive Symptoms as assessed by the Hamilton Depression Rating Scale (HRSD-24)
The Hamilton Depression Rating Scale (HRSD-24) is a clinician-administered scale used to rate the severity of depressive symptoms. Higher total scores indicate greater severity of depression.
Time frame: baseline, 3 months, and 6 months
Traditional Chinese Medicine (TCM) Syndrome Score
A diagnostic scale based on the TCM Diagnostic and Treatment Guidelines for Vascular Mild Cognitive Impairment (2024). It evaluates TCM symptoms, tongue, and pulse features to diagnose syndrome patterns (e.g., Kidney Deficiency with Blood Stasis). A total score ≥12 confirms the diagnosis of a specific syndrome pattern.
Time frame: baseline, 3 months, and 6 months
MRI Examination
MRI scans are used to comprehensively assess the impact of electroacupuncture on brain structure and function.
Time frame: baseline, 3 months, and 6 months
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire assessing sleep quality and disturbances over a 1-month interval. The global score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: baseline, 3 months, and 6 months
Independence in Activities of Daily Living as assessed by the modified Barthel Index (MBI)
The modified Barthel Index (MBI) is an observer-rated scale used to measure a person's performance in basic activities of daily living (ADL), such as feeding, bathing, and mobility. The total score ranges from 0 to 100, with higher scores indicating greater independence.
Time frame: Baseline, 3 months, 6 months
Functional Disability as assessed by the modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is a clinician-reported measure of global disability after a stroke. Scores range from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.
Time frame: Baseline, 3 months, 6 months
No study locations are listed for this record.
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Second Affiliated Hospital, School of Medicine, Zhejiang University