Evaluation of Clinical Efficacy and Mechanism of Hand Jing-Well Acupoint Transcutaneous Electrical Stimulation in Improving Post-Stroke Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- MoCA（Montreal Cognitive Assessment)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
MoCA（Montreal Cognitive Assessment)
时间窗: From enrollment to the end of treatment at 4 weeks
次要结局
- Activities of Daily Living Scale（ADL）(From enrollment to the end of treatment at 4 weeks)
- Mini-Mental State Examination（MMSE）(From enrollment to the end of treatment at 4 weeks)
- Vascular Dementia Assessment Scale-cognitive subscale（VaDAS-cog ）(From enrollment to the end of treatment at 4 weeks)
研究者
Gao Liang
Associate Chief Physician, Department of Acupuncture, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine