Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia

Not Applicable

Not yet recruiting

• Conditions: Behavioral and Psychological Symptoms of Dementia (BPSD); Dementia

• Registration Number: NCT07204145
• Lead Sponsor: China Medical University Hospital

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study Start: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-01-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory (NPI) 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)	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 Outcome Measures

Name	Time	Method
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).	The Mini-Mental State Examination (MMSE) assesses global cognitive function. The MMSE total score ranges from 0 to 30, with higher scores indicating better cognitive performance (better outcome).
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).	The Activities of Daily Living (ADL) scale evaluates functional independence in daily activities such as feeding, bathing, dressing, mobility, and continence. Scoring is based on the Barthel Index method, with a total score ranging from 0 to 100. Higher scores indicate greater independence in daily activities (better outcome).
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).	Tracks changes in the dosage and number of prescribed psychotropic medications, including antipsychotics, antidepressants, anxiolytics, and hypnotics.

Trial Locations

Locations (2)

Taoyuan Veteran's Home; 🇨🇳 Taoyuan, Bade District, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taichung City, Taiwan