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NCT Number: NCT07204145

Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taoyuan Veteran's Home, Taoyuan City, Bade District, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Neuropsychiatric Inventory (NPI) total score

    Time frame: 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 outcomes

  1. Mini-Mental State Examination (MMSE) total score

    Time frame: 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).

  2. Activities of Daily Living (ADL) total score

    Time frame: 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).

  3. Change in psychotropic medication use

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Professor of Acupuncture, China Medical University, MD, PhD

CONTACT

[email protected]

+886-4-2205-2121

shu-yun Tang, MS, RN

CONTACT

[email protected]

+886920455281

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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