NCT07204145

Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia

The Efficacy of Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-01-30
• Completion: 2026-03-31
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

2 sites across 1 country: Taiwan