Key Technical Research on the Treatment of Post-stroke Cognitive Impairment With Brain Electric Field Therapy Based on Acupoint Regulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Change in Mini-Mental State Examination (MMSE) Score
研究概览
简要总结
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.
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
- •Meets diagnostic criteria for Vascular Cognitive Impairment (VCI) per the 2024 Chinese VCI guidelines.
- •Meets TCM diagnostic criteria per the 2024 Vascular Mild Cognitive Impairment guidelines.
- •Cognitive scores: MMSE 12-24 and MoCA <24; NIHSS ≤8; AD-8 <
- •Age 35-80 years.
- •Basic communication ability (Mandarin) and has a stable caregiver.
- •Provides written informed consent.
排除标准
- •Severe chronic systemic diseases (e.g., cardiac, hepatic, renal, hematologic) or unstable cardiovascular/cerebrovascular disease.
- •Local skin conditions (e.g., herpes, ulceration, keloid) contraindicating acupuncture.
- •Contraindications for repeated MRI (e.g., claustrophobia, post-aneurysm embolization).
- •Pre-existing cognitive impairment or other major uncontrolled neurological/psychiatric disorders.
- •Deemed unsuitable for the study by investigators.
- •Participation in another clinical trial within the past 3 months.
研究组 & 干预措施
True Electroacupuncture
干预措施: True Electroacupuncture (Procedure)
Sham Electroacupuncture
干预措施: Sham Electroacupuncture (Procedure)
结局指标
主要结局
Change in Mini-Mental State Examination (MMSE) Score
时间窗: baseline, 3 months and 6 months post-treatment.
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.
Change in MoCA (Montreal Cognitive Assessment) Scale Score
时间窗: baseline, 3 months and 6 months post-treatment.
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.
Change in Clinical Dementia Rating (CDR) scale Score
时间窗: baseline, 3 months and 6 months post-treatment.
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.
Change in NTB (Neuropsychological Test Battery) Score
时间窗: baseline, 3 months and 6 months post-treatment.
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.
次要结局
- Multimodal functional Near-Infrared Spectroscopy - Electroencephalogram (fNIRS-EEG) Assessment(baseline, 3 months, and 6 month)
- Quality of Life as assessed by the Stroke-Specific Quality of Life Scale (SS-QOL)(baseline, 3 months, and 6 months.)
- Depressive Symptoms as assessed by the Hamilton Depression Rating Scale (HRSD-24)(baseline, 3 months, and 6 months)
- Traditional Chinese Medicine (TCM) Syndrome Score(baseline, 3 months, and 6 months)
- MRI Examination(baseline, 3 months, and 6 months)
- Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)(baseline, 3 months, and 6 months)
- Independence in Activities of Daily Living as assessed by the modified Barthel Index (MBI)(Baseline, 3 months, 6 months)
- Functional Disability as assessed by the modified Rankin Scale (mRS)(Baseline, 3 months, 6 months)