Behavioral and Psychological Symptoms of Dementia (BPSD), Dementia
Conditions
Keywords
Dementia, Behavioral and Psychological Symptoms of Dementia (BPSD), Laser Acupuncture
Brief 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.
Interventions
DEVICELaser 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.
DEVICESham 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.
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric Inventory (NPI) total score | 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
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination (MMSE) total score | 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). |
| Activities of Daily Living (ADL) total score | 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). |
| Change in psychotropic medication use | 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. |
Countries
Taiwan
Contacts
Primary ContactProfessor of Acupuncture, China Medical University, MD, PhD
Backup Contactshu-yun Tang, MS, RN
Outcome results
None listed