Behavioral and Psychological Symptoms of Dementia (BPSD)NCT07204145
Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia
A study testing Laser Acupuncture (808 nm laser pen) in people with Behavioral and Psychological Symptoms of Dementia (BPSD) and Dementia, run by China Medical University Hospital at 2 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioral and Psychological Symptoms of Dementia (BPSD), Dementia
- What is being tested?
- Laser Acupuncture (808 nm laser pen)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Oct 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Professor of Acupuncture, China Medical University, MD, PhD contact
Taiwan2 sites
China Medical University Hospital
Taichung, Taichung City, 40402
Clinical Trial Office, China Medical University Hospital, +886-4-2205-2121, cheerleador@mail2000.com.tw
shu-yun Research Coordinator
Taoyuan Veteran's Home
Taoyuan City, Bade District, 33463
Head of Health Care Section, +886-3-3681140 ext. 295, cheerleador@mail2000.com.tw
About this study
Official title: The Efficacy of Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial
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).
Read the 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.
- Being tested
- Laser Acupuncture (808 nm laser pen), Sham Laser Acupuncture
- Keywords
- Dementia, Behavioral and Psychological Symptoms of Dementia (BPSD), Laser Acupuncture
- Medical subject headings
- Behavior, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser Acupuncture | Experimental | Participants receive laser acupuncture with an 808 nm laser pen at GV20, ST36, and PC6, three times per week, 10 seconds per acupoint. Receives: Device: Laser Acupuncture (808 nm laser pen) |
| Sham Laser Acupuncture | Placebo comparator | Participants receive sham laser acupuncture with the same procedure but without active laser output. Receives: Device: Sham Laser Acupuncture |
| Usual Care | No intervention | Participants receive standard dementia care provided by the facility, including routine medical treatment, nursing care, and daily support, without additional acupuncture or laser intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Inventory (NPI) total score
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).
Measured: 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 outcomes (3)
Mini-Mental State Examination (MMSE) total score
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).
Measured: 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
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).
Measured: 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
Tracks changes in the dosage and number of prescribed psychotropic medications, including antipsychotics, antidepressants, anxiolytics, and hypnotics.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral and Psychological Symptoms of Dementia (BPSD)Studies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a parallel design to one of three groups: laser acupuncture, sham laser acupuncture, or usual care. The interventions will be delivered concurrently, and outcomes will be assessed at baseline and five follow-up time points.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
- Investigators
- Yuchen Lee, MD, PhD, Principal investigator, Principal Investigator, Department of Acupuncture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204145
- Sponsor's protocol ID
- CMUH114-REC3-115
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been determined. Any decision regarding data sharing will require careful consideration of participant privacy and data protection, particularly for individuals with dementia.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Laser Acupuncture for Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07204145
- Acronym / sponsor ID
- CMUH114-REC3-115
- Keywords
- Dementia, Behavioral and Psychological Symptoms of Dementia (BPSD), Laser Acupuncture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a parallel design to one of three groups: laser acupuncture, sham laser acupuncture, or usual care. The interventions will be delivered concurrently, and outcomes will be assessed at baseline and five follow-up time points.
| Arm | Type | Receives |
|---|---|---|
| Laser Acupuncture | Experimental | Device: Laser Acupuncture (808 nm laser pen)Participants receive laser acupuncture with an 808 nm laser pen at GV20, ST36, and PC6, three times per week, 10 seconds per acupoint. |
| Sham Laser Acupuncture | Placebo comparator | Device: Sham Laser AcupunctureParticipants receive sham laser acupuncture with the same procedure but without active laser output. |
| Usual Care | No intervention | –Participants receive standard dementia care provided by the facility, including routine medical treatment, nursing care, and daily support, without additional acupuncture or laser intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Laser Acupuncture |
| Sham Laser AcupunctureParticipants 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. | Device | Sham Laser Acupuncture |
Primary outcome
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).
3 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been determined. Any decision regarding data sharing will require careful consideration of participant privacy and data protection, particularly for individuals with dementia.
Related trials for Behavioral and Psychological Symptoms of Dementia (BPSD)
Recruiting
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia
BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion
Recruiting
Web-Based Psychoeducation for Dementia Caregivers
Dementia
Recruiting
Transcranial Random Noise (tRNS) for BPSD in Alzheimer's Disease: A Double-blind Randomized Controlled Trial
Transcranial Random Noise Stimulation (tRNS), Electroencephalography
Recruiting
SUNAM Protocol for Managing BPSD
Dementia
Recruiting
Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD
Mild Cognitive Impairment, Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Professor of Acupuncture, China Medical University, MD, PhD contact
Yuchen Lee, MD, PhD principal investigator
Principal Investigator, Department of Acupuncture
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Acupuncture (808 nm laser pen) in people with Behavioral and Psychological Symptoms of Dementia (BPSD) and Dementia, run by China Medical University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor of Acupuncture, China Medical University, MD, PhD (+886-4-2205-2121, cheerleador@mail2000.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.