Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia

NCT07204145 | Not Yet Recruiting

• 1 other identifier: CMUH114-REC3-115
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Behavioral and Psychological Symptoms of Dementia (BPSD); Dementia

Keywords

Dementia; Behavioral and Psychological Symptoms of Dementia (BPSD); Laser Acupuncture

Outcome Measures

Primary Outcomes (1)

• Neuropsychiatric Inventory (NPI) total score

  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).

  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)

Secondary Outcomes (3)

• 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).

Study Arms (3)

Laser Acupuncture

EXPERIMENTAL

Participants receive laser acupuncture with an 808 nm laser pen at GV20, ST36, and PC6, three times per week, 10 seconds per acupoint.

Device: Laser Acupuncture (808 nm laser pen)

Sham Laser Acupuncture

PLACEBO COMPARATOR

Participants receive sham laser acupuncture with the same procedure but without active laser output.

Device: Sham Laser Acupuncture

Usual Care

NO INTERVENTION

Participants receive standard dementia care provided by the facility, including routine medical treatment, nursing care, and daily support, without additional acupuncture or laser intervention.

Interventions

Laser Acupuncture (808 nm laser pen) DEVICE

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.

Laser Acupuncture

Sham Laser Acupuncture DEVICE

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.

Sham Laser Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (2)

Taoyuan Veteran's Home

Taoyuan, Bade District, 33463, Taiwan

Location

China Medical University Hospital

Taichung, Taichung City, 40402, Taiwan

Location

MeSH Terms

Conditions

Behavior; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yuchen Lee, MD, PhD

  Principal Investigator, Department of Acupuncture

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor of Acupuncture, China Medical University, MD, PhD

CONTACT

+886-4-2205-2121; cheerleador@mail2000.com.tw

shu-yun Tang, MS, RN

CONTACT

+886920455281; cheerleador@mail2000.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned in a parallel design to one of three groups: laser acupuncture, sham laser acupuncture, or usual care. The interventions will be delivered concurrently, and outcomes will be assessed at baseline and five follow-up time points.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 31, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

TW (2)