This study evaluates a non-invasive electrical stimulation therapy applied to specific acupoints on the fingers (called Jing-Well points) to improve thinking and memory problems after stroke.
Purpose: Many stroke survivors develop cognitive difficulties (problems with memory, attention, and decision-making). Current treatments are limited. This study tests whether gentle electrical stimulation to hand acupoints can improve these symptoms.
Who can participate: Adults aged \[35-80\] who have had an ischemic stroke and now have mild to moderate cognitive impairment.
What happens: Participants will be randomly assigned to receive either (1) active electrical stimulation to hand Jing-Well points, (2) sham (fake) stimulation. Treatment will last 4 weeks, 6 sessions per week, each 30 minutes, with a stimulation frequency of 10 Hz and intensity adjusted to each participant's tolerance. Cognitive tests and brain imaging will be done before and after treatment.
Potential benefits: Participants may experience improved cognitive function. The study will also help researchers understand how this therapy works in the brain.
Risks: The electrical stimulation may cause mild tingling or skin irritation at the electrode sites. Brain imaging is non-invasive and safe. All procedures will be performed by trained professionals.
Aged 35-80 years;
Stroke duration within 2 weeks to 6 months post-onset;
Cognitive impairment confirmed by neuropsychological assessment: Montreal Cognitive Assessment (MoCA) score < 26;
Clinical evaluation excludes delirium, major depressive disorder, schizophrenia, or other primary psychiatric/behavioral disorders as the principal cause of current cognitive impairment. No history of other known neurological diseases that may cause cognitive impairment (e.g., multiple sclerosis, encephalitis, Parkinson's disease, post-traumatic dementia, normal pressure hydrocephalus, etc.);
Unstable vital signs or life-threatening comorbidities;
Implanted devices (cardiac pacemaker/defibrillator, deep brain stimulator, etc.);
History of epilepsy or epileptic seizures;
Pregnant or lactating women;
Parallel
Transcutaneous Electrical Stimulation at Jing-Well Acupoints
DeviceDevice-based transcutaneous electrical stimulation (TES) delivered to six hand Jing-Well acupoints: Shaoze (SI1), Shangyang (LI1), Zhongchong (PC9), Guanchong (SJ1), Shaochong (HT9), and Dadun (LR1). A custom-designed portable electrical stimulator (model YM-JX-V01, manufactured by Yimai Artificial Intelligence Medical Technology (Tianjin) Co., Ltd.) is used with disposable self-adhesive reference electrodes (4 × 4 cm) and stimulation electrodes (diameter 5 mm). Stimulation parameters: square wave, frequency 10 Hz, pulse width 320 μs, intensity individually titrated to sensory threshold (typically 0-1 mA), session duration 30 minutes. Treatment schedule: 6 sessions per week (Monday-Saturday) for 4 consecutive weeks, totaling 24 sessions. Electrodes are placed bilaterally at the designated acupoints according to WHO Standard Acupuncture Point Locations.
Transcutaneous Sham Electrical Stimulation at Jing-Well Acupoints
DeviceDevice-based sham transcutaneous electrical stimulation (TES) delivered to six hand Jing-Well acupoints: Shaoze (SI1), Shangyang (LI1), Zhongchong (PC9), Guanchong (SJ1), Shaochong (HT9), and Dadun (LR1). A custom-designed portable electrical stimulator with open-circuit design (model YM-JX-V01, manufactured by Yimai Artificial Intelligence Medical Technology (Tianjin) Co., Ltd.) is used with disposable self-adhesive reference electrodes (4 × 4 cm) and stimulation electrodes (diameter 5 mm). The device delivers ineffective stimulation (0 Hz, no current output) while maintaining identical visual and tactile feedback. Sessions follow the same schedule as the active group: 30 minutes per session, 6 sessions per week for 4 consecutive weeks (24 sessions total). Electrodes are placed bilaterally at the designated acupoints according to WHO Standard Acupuncture Point Locations.
MoCA（Montreal Cognitive Assessment)
Mini-Mental State Examination（MMSE）
Vascular Dementia Assessment Scale-cognitive subscale（VaDAS-cog ）
Activities of Daily Living Scale（ADL）
Whole-brain frequency band absolute and relative power derived from resting-state electroencephalography (EEG)
Resting-state EEG signals will be acquired. Absolute power and relative power of multiple frequency bands (delta, theta, alpha, beta) across the whole brain will be quantified to reflect cortical electrical activity.
Concentration changes of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) measured by functional near-infrared spectroscopy (fNIRS)
Prefrontal cortical hemodynamic signals will be acquired via resting-state functional near-infrared spectroscopy. Concentration changes of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) will be quantified to evaluate cerebral hemodynamic function.
C-Reactive Protein
Folic Acid / Folate
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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead sponsor
Tianjin University of Traditional Chinese Medicine
Collaborator
