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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Sham Laser Acupuncture | Placebo Comparator | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professor of Acupuncture, China Medical University, MD, PhD | Contact | +886-4-2205-2121 | cheerleador@mail2000.com.tw | |
| shu-yun Tang, MS, RN | Contact | +886920455281 | cheerleador@mail2000.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yuchen Lee, MD, PhD | Principal Investigator, Department of Acupuncture | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taoyuan Veteran's Home | Taoyuan City | Bade District | 33463 | Taiwan |
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.
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| ID | Term |
|---|---|
| D001519 | Behavior |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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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.
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Participants, care providers, and outcome assessors will be masked to group assignment. The investigator delivering the intervention will be aware of the assignment due to the nature of the laser acupuncture procedure.
| 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. |
|
| 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). | 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. | 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). |
| China Medical University Hospital | Taichung | Taichung City | 40402 | Taiwan |
|
| D001523 | Mental Disorders |