Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia

Официальное название

The Efficacy of Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство Laser Acupuncture (808 nm laser pen)
  Participants receive laser acupuncture using an 808 nm, 100 mW semiconductor laser pen applied at acupoints GV20, bilateral ST36, and bilateral PC6. Each acupoint is irradiated for 10 seconds, three times per week, for 12 weeks.
• Устройство Sham Laser Acupuncture
  Participants receive the same procedure as the laser acupuncture group, using an 808 nm semiconductor laser pen applied at acupoints GV20, bilateral ST36, and bilateral PC6. The device is identical in appearance and produces lights and beeping sounds; however, it delivers no energy output. Each acupoint is contacted for 10 seconds, three times per week, for 12 weeks.

Первичные конечные точки

• Neuropsychiatric Inventory (NPI) total score [Срок оценки: 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)]

Вторичные конечные точки (3)

• Mini-Mental State Examination (MMSE) total score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Тайвань · 2 центра

• Taoyuan Veteran's Home — Taoyuan City
• China Medical University Hospital — Taichung

Идентификаторы

NCT: NCT07204145 · CMUH114-REC3-115

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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