Acoustic Stimulation, Cognitive Training, Dementia, Healthcare Disparities, Precision Medicine
Conditions
Keywords
Dementia, Gamma frequency auditory tone, Personalize intervention, Urban-rural disparities, Cognitive training
Brief summary
As Taiwan transitions into a super-aged society, rising dementia rates have severely strained long-term care systems. Although current daycare centers provide multi-modal programs, they remain limited to behavioral training, lacking precise interventions targeting brain function and neuroplasticity or integrated non-invasive neuromodulation technologies. Furthermore, urban-rural disparities in resources, staffing allocation, and tech experience hinder practical deployment, with empirical research remaining scarce. Addressing this gap, this study investigates a smart brain health promotion model combining personalized gamma music stimulation and cognitive training for mild cognitive impairment and dementia, while evaluating its feasibility across diverse care settings.
Detailed description
As Taiwan transitions into a super-aged society, the prevalence of dementia continues to rise, and its associated behavioral and psychological symptoms have placed a significant burden on the long-term care system. While current adult daycare centers and dementia care center have widely adopted multi-modal health promotion programs-which offer certain benefits for functional maintenance-they largely focus on behavioral training levels. They rarely incorporate precise intervention designs that directly act on brain function and neuroplasticity, nor do they integrate safe, low-invasive brain neuromodulation technologies suitable for long-term care settings. Furthermore, differences in resource conditions, staffing allocation, and technological experience across different care settings (such as urban versus rural areas) pose challenges to the practical promotion and application of long-term care technology, with relevant empirical research remaining relatively limited. To address these research gaps, this study combines personalized gamma music stimulation with cognitive activity training to investigate their effects on cognitive performance and psychological states in older adults with mild cognitive impairment and mild dementia. Additionally, it evaluates the feasibility and acceptability of different intervention tools across various care settings, serving as an empirical reference for the development of smart brain health promotion models.
Interventions
DEVICEDigital personalized intervention system (active setting)
Participants will receive auditory stimulation using the gamma auditory stimulation device (active setting) during cognitive training activity for 1 hour per day, 2 days a week, over 12 weeks, for a total of 24 hours.
Participants will receive auditory stimulation using the gamma auditory stimulation device (active setting) during cognitive training activity for 1 hour per day, 2 days a week, over 12 weeks, for a total of 24 hours.
Participants will receive auditory stimulation using the gamma auditory stimulation device (sham setting) during cognitive training activity for 1 hour per day, 2 days a week, over 12 weeks, for a total of 24 hours.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 60 years * The score of MoCA between 10 to 25
Exclusion criteria
* Diagnosis of other psychiatric or neurological disorders, and those with a history of neurological or psychiatric disorders that may affect cognitive assessment or performance. For example (but not limited to): Parkinson's disease, schizophrenia, major depressive disorder, epilepsy, severe traumatic brain injury with loss of consciousness, and stroke. * Drug, Nicotine or alcohol addictions * Serious heart, liver or kidney disorders, and visual, auditory or motor impairments interfering with neuropsychological tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change score of Montreal Cognitive Assessment (MoCA) | baseline (T1), through intervention completion, an average of 3 month (T2) | This scale is one of the most commonly used tools for assessing mild cognitive impairment and early-stage dementia, evaluating capacities such as executive function, attention, visuospatial abilities, language, memory, and orientation. The scale has a maximum score of 30, with higher scores indicating better cognitive function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change score of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) | baseline (T1), through intervention completion, an average of 3 month (T2) | A neuropsychological test used to assess cognitive impairment, particularly in the context of Alzheimer's disease. The ADAS-Cog typically has a total score ranging from 0 to 70, with higher scores indicating greater cognitive impairment. |
| Change score of the Neuropsychiatric Inventory Questionnaire (NPI-Q) | baseline (T1), through intervention completion, an average of 3 month (T2) | Through semi-structured interviews with primary caregivers or observers, this scale will be used to assess behavioral and psychological symptoms of dementia (BPSD). It consists of 12 items, including depression, anxiety, agitation, hallucinations, delusions, insomnia, behavioral problems, and emotional instability. Each item is scored in two parts: frequency (1 = rarely, 2 = sometimes, 3 = often, 4 = very often/almost daily) and severity (1 = mild, 2 = moderate, 3 = severe). The symptom score for each item equals frequency multiplied by severity (ranging from 0 to 12 points). The total score of the scale ranges from 0 to 144, with higher scores indicating more severe symptoms. |
| Change score of the Geriatric Depression Scale-15 (GDS-15). | baseline (T1), through intervention completion, an average of 3 month (T2) | This scale assesses the depressive emotional states of older adults through self-administration or interviews, covering dimensions such as motivation for activity participation, social and life satisfaction, energy levels, fatigue, and feelings of sadness or hopelessness. It consists of 15 items, with each item scored 0 or 1 (0 = No, 1 = Yes); higher scores indicate a more severe level of depression. |
| User Subjective Experience Assessment | Through intervention completion, an average of 3 month (T2) | We will collect subjective assessments from participants and the staff in daycare center across three dimensions: intervention acceptability, system usability, and overall satisfaction. Each dimension will be evaluated using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). |
| Qualitative Interview | Through intervention completion, an average of 3 month (T2) | Using purposive sampling, we will invite willing older adults and care workers with good attendance from each experimental group (anticipating 2 older adults and 2 care workers per group, totaling approximately 16 participants) to conduct semi-structured in-depth interviews. Each interview will last approximately 30 to 60 minutes, and will be audio-recorded with the participants' consent for subsequent transcription. The main topics will include: (1) overall impressions and acceptability of the intervention program; (2) subjective experiences regarding gamma music and technological devices; (3) setting- and resource-related factors; (4) gender- and personal background-related experiences; (5) practical implementation challenges faced by care workers and their coping strategies; and (6) recommendations for future program adjustments and scaling. Qualitative data will be analyzed using thematic analysis with the qualitative analysis software ATLAS.ti. |
Countries
Taiwan
Contacts
CONTACTChia-Hsiung Cheng, Ph.D.
Outcome results
None listed