Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia

China Medical University

Status: Not yet enrolling

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

Treatments: Device: Sham Laser Acupuncture; Device: Laser Acupuncture (808 nm laser pen)

Study type: Interventional

Funder types: Other

Identifiers

NCT07204145

CMUH114-REC3-115

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Laser Acupuncture

Experimental group

Description:

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

Treatment:

Device: Laser Acupuncture (808 nm laser pen)

Sham Laser Acupuncture

Placebo Comparator group

Description:

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

Treatment:

Device: Sham Laser Acupuncture

Usual Care

No Intervention group

Description:

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