The Efficacy of Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Neuropsychiatric Inventory (NPI) total score
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Laser Acupuncture
Participants receive laser acupuncture with an 808 nm laser pen at GV20, ST36, and PC6, three times per week, 10 seconds per acupoint.
Intervention: Laser Acupuncture (808 nm laser pen) (Device)
Sham Laser Acupuncture
Participants receive sham laser acupuncture with the same procedure but without active laser output.
Intervention: Sham Laser Acupuncture (Device)
Usual Care
Participants receive standard dementia care provided by the facility, including routine medical treatment, nursing care, and daily support, without additional acupuncture or laser intervention.
Outcomes
Primary Outcomes
Neuropsychiatric Inventory (NPI) total score
Time Frame: 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).
Secondary Outcomes
- 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).)
- 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).)
Investigators
Yu-Chen Lee
Professor
China Medical University Hospital