Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia

NCT ID: NCT07204145

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-03-31

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.

Conditions

Behavioral and Psychological Symptoms of Dementia (BPSD); Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Laser Acupuncture (808 nm laser pen)

Intervention Type: 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.

Sham Laser Acupuncture

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

Group Type: PLACEBO_COMPARATOR

Sham Laser Acupuncture

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu-Chen Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuchen Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator, Department of Acupuncture

Locations

Taoyuan Veteran's Home

Taoyuan, Bade District, Taiwan

China Medical University Hospital

Taichung, Taichung City, Taiwan

Countries

Taiwan

Central Contacts

Professor of Acupuncture, China Medical University, MD, PhD

Role: CONTACT

cheerleador@mail2000.com.tw

+886-4-2205-2121

shu-yun Tang, MS, RN

Role: CONTACT

cheerleador@mail2000.com.tw

+886920455281

Facility Contacts

Head of Health Care Section

Role: primary

cheerleador@mail2000.com.tw

+886-3-3681140 ext. 295

Clinical Trial Office, China Medical University Hospital

Role: primary

cheerleador@mail2000.com.tw

+886-4-2205-2121

shu-yun Research Coordinator

Role: backup

Other Identifiers

CMUH114-REC3-115

Identifier Type: -

Identifier Source: org_study_id