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

Обзор

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.

Вмешательства

• Устройство Transcutaneous Electrical Stimulation at Jing-Well Acupoints
  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 wa
• Устройство Transcutaneous Sham Electrical Stimulation at Jing-Well Acupoints
  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

Первичные конечные точки

• MoCA（Montreal Cognitive Assessment) [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Вторичные конечные точки (3)

• Mini-Mental State Examination（MMSE） [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Vascular Dementia Assessment Scale-cognitive subscale（VaDAS-cog ） [Срок оценки: From enrollment to the end of treatment at 4 weeks]
• Activities of Daily Living Scale（ADL） [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

• 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.);
• No severe aphasia; able to cooperate with scale assessments and complete the treatment protocol required by this study;
• Voluntary participation in this study; the participant or their legally authorized representative has signed the informed consent form.

Критерии исключения

• 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;
• Concurrent use of other medications affecting cognitive function;
• Allergy to the study intervention device or history of serious adverse reactions;
• Severe arrhythmia, malignant hypertension, or severe dysfunction of vital organs (heart, liver, kidney, etc.);
• Individuals unable to participate in treatment due to severe hearing or visual impairment, or bilateral limb paralysis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Тяньцзинь

Публикации

• Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, Hatsukami TS, Higashida RT, Johnston SC, Kidwell CS, Lutsep HL, Miller E, Sacco RL; American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Interdisciplinary Council on Periph PMID 19423857
• Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascul PMID 23652265

Идентификаторы

NCT: NCT07736885 · TYLL2026-K-076

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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