Personalized Sensory Stimulation: Urban and Rural Dementia Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 60 years
The score of MoCA between 10 to 25
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital personalized intervention system (active setting)
DeviceParticipants 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.
Gamma auditory stimulation device (active setting)
DeviceParticipants 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.
Gamma auditory stimulation device (sham setting)
DeviceParticipants 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.
Treatment groups
90 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Urban High-Tech Experimental GroupExperimental treatment 1 intervention
Group B: Urban Low-Tech Experimental GroupExperimental treatment 1 intervention
Group C: Urban Control GroupSham comparator 1 intervention
Group D: Rural High-Tech Experimental GroupExperimental treatment 1 intervention
Group E: Rural Low-Tech Experimental GroupExperimental treatment 1 intervention
Group F: Rural Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change score of Montreal Cognitive Assessment (MoCA)
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.
Time frame
baseline (T1), through intervention completion, an average of 3 month (T2)Secondary outcomes
1
Change score of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
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.
Time frame
baseline (T1), through intervention completion, an average of 3 month (T2)2
Change score of the Neuropsychiatric Inventory Questionnaire (NPI-Q)
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.
Time frame
baseline (T1), through intervention completion, an average of 3 month (T2)3
Change score of the Geriatric Depression Scale-15 (GDS-15).
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.
Time frame
baseline (T1), through intervention completion, an average of 3 month (T2)4
User Subjective Experience Assessment
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).
Time frame
Through intervention completion, an average of 3 month (T2)Sponsors and contacts
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Source ClinicalTrials.gov
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