Evaluation of Clinical Efficacy and Mechanism of Hand Jing-Well Acupoint Transcutaneous Electrical Stimulation in Improving Post-Stroke Cognitive Impairment

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Post-Stroke Cognitive Impairment (PSCI)

Interventions

Transcutaneous Electrical Stimulation at Jing-Well AcupointsDEVICE

Device-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 AcupointsDEVICE

Device-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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 35-80 years; 2. Stroke duration within 2 weeks to 6 months post-onset; 3. Cognitive impairment confirmed by neuropsychological assessment: Montreal Cognitive Assessment (MoCA) score \< 26; 4. 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.); 5. No severe aphasia; able to cooperate with scale assessments and complete the treatment protocol required by this study; 6. Voluntary participation in this study; the participant or their legally authorized representative has signed the informed consent form. Exclusion Criteria: 1. Unstable vital signs or life-threatening comorbidities; 2. Implanted devices (cardiac pacemaker/defibrillator, deep brain stimulator, etc.); 3. History of epilepsy or epileptic seizures; 4. Pregnant or lactating women; 5. Concurrent use of other medications affecting cognitive function; 6. Allergy to the study intervention device or history of serious adverse reactions; 7. Severe arrhythmia, malignant hypertension, or severe dysfunction of vital organs (heart, liver, kidney, etc.); 8. Individuals unable to participate in treatment due to severe hearing or visual impairment, or bilateral limb paralysis.

Outcomes

Primary Outcomes

MoCA（Montreal Cognitive Assessment)

Time frame: From enrollment to the end of treatment at 4 weeks

Secondary Outcomes

Mini-Mental State Examination（MMSE）

Time frame: From enrollment to the end of treatment at 4 weeks

Vascular Dementia Assessment Scale-cognitive subscale（VaDAS-cog ）

Time frame: From enrollment to the end of treatment at 4 weeks

Activities of Daily Living Scale（ADL）

Time frame: From enrollment to the end of treatment at 4 weeks

Evaluation of Clinical Efficacy and Mechanism of Hand Jing-Well Acupoint Transcutaneous Electrical Stimulation in Improving Post-Stroke Cognitive Impairment

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts