The Efficacy of Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Neuropsychiatric Inventory (NPI) total score
研究概览
简要总结
This study uses a laser acupuncture pen to stimulate specific acupoints, aiming to evaluate its effectiveness in improving behavioral and psychological symptoms of dementia (BPSD).
详细描述
Participants will be dementia patients residing in institutions who present with BPSD symptoms. A laser acupuncture pen with a wavelength of 808 nm will be used to irradiate the following acupoints three times per week: GV20, ST36, and PC6, with each acupoint irradiated for 10 seconds per session. The severity of BPSD, activities of daily living, and cognitive function will be assessed using the NPI, MMSE, and ADL scales, respectively, while recording the dosage of oral Psychotropic medicationsmedications. A total of six assessments, including the baseline, will be conducted to evaluate the immediate, short-term, and long-term effects of laser acupuncture.
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)
盲法说明
Participants, care providers, and outcome assessors will be masked to group assignment. The investigator delivering the intervention will be aware of the assignment due to the nature of the laser acupuncture procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Dementia: Participants must have a clinical diagnosis of dementia, of any type or severity
- •Consent: Written informed consent provided by the participant's family or legal representative.
排除标准
- •Refusal to sign the informed consent form.
- •Unable to cooperate with the intervention procedure despite repeated attempts.
- •History of epilepsy.
- •End-stage liver disease.
- •End-stage renal disease requiring hemodialysis.
- •Presence of brain tumor or history of major brain surgery.
- •Acute cardiovascular or cerebrovascular events within the past 3 months (e.g., unstable angina, myocardial infarction, stroke).
- •Use of a cardiac pacemaker.
- •Currently receiving acupuncture or traditional Chinese medicine treatment.
- •Presence of acute illness.
- •Abnormal blood pressure or fever.
- •Presence of malignant tumor.
- •Pregnancy.
- •Presence of unusual physical abnormalities or sensory nerve disorders.
结局指标
主要结局
Neuropsychiatric Inventory (NPI) total score
时间窗: Baseline (before intervention), 1 week after first intervention, 1 month after first intervention, 2 months after first intervention, 3 months after first intervention, and 4 months after first intervention (also 1 month after the end of intervention)
The Neuropsychiatric Inventory (NPI) assesses behavioral and psychological symptoms of dementia. The NPI total score ranges from 0 to 144, with higher scores indicating more severe symptoms (worse outcome).
次要结局
- Mini-Mental State Examination (MMSE) total score(Baseline (before intervention), 1 week after first intervention, 1 month after first intervention, 2 months after first intervention, 3 months after first intervention, and 4 months after first intervention ( also 1 month after the end of intervention).)
- Activities of Daily Living (ADL) total score(Baseline (before intervention), 1 week after first intervention, 1 month after first intervention, 2 months after first intervention, 3 months after first intervention, and 4 months after first intervention ( also 1 month after the end of intervention).)
- Change in psychotropic medication use(Baseline (before intervention), 1 week after first intervention, 1 month after first intervention, 2 months after first intervention, 3 months after first intervention, and 4 months after first intervention (also 1 month after the end of intervention).)
研究者
Yu-Chen Lee
Professor
China Medical University Hospital