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Not yet recruiting NCT07204145

Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia

No phase Interventional Behavioral and Psychological Symptoms of Dementia (BPSD) Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laser Acupuncture (808 nm laser pen), Sham Laser Acupuncture.
Who it may be relevant to
Registry conditions: Behavioral and Psychological Symptoms of Dementia (BPSD), Dementia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (3)
  • 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).]
  • 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).]
  • 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).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • Taoyuan Veteran's Home — Taoyuan City
  • China Medical University Hospital — Taichung

Identifiers

NCT: NCT07204145 · CMUH114-REC3-115

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗