ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia (Phase 2)

Study Overview
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Brief Summary
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The proposed research project aims to answer the question Are immersive technology systems effective in the management and treatment of patients with BPSD?. This project is composed of three phases and the current study is the second phase. The phase 2 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its clinical effectiveness, safety, usability, and acceptability among patients with mild to moderate Alzheimer's disease.

Official Title
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Developing Immersive Gamification Technology Systems for the Management of Patients With Alzheimer's Disease With Behavioral and Psychological Symptoms of Dementia (Phase 2 Trial)

Conditions
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Dementia Alzheimers

Intervention / Treatment
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* Other: Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 60 years old or older Diagnosed with mild to moderate Alzheimer's dementia according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria Montreal Cognitive Assessment-Philippines (MOCA-P) score of 10-20 inclusive Neuropsychiatric Inventory (NPI-12) score 1-50 inclusive Reisberg Scale Stage 4-5 inclusive Stable dose of antidepressants for the past 6 weeks Stable dose of antipsychotics for the past 4 weeks Able to walk unassisted or with minimal assistance, with or without assistive device No other explanation for condition based on reasonable clinical diagnostics Exclusion Criteria: Have mild cognitive impairment (no dementia) Have MOCA-P score less than 10 or more than 20 Other non-amnestic dementia syndromes Have receptive aphasia Have significant visual or hearing impairment Have an active psychiatric disorder prior to Alzheimer dementia diagnosis Had previous episodes of seizures, diagnosis of epilepsy, or intake of antiepileptic or seizure medications Have quadriplegia or paralysis of the dominant hand Have a history of motion sickness Experience claustrophobia Have a diagnosis of a terminal illness or a life expectancy of less than one year

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Head-mounted display (HMD)<br>The HMD system uses a commercially available virtual headset, the Oculus/Meta Quest 2, which allows a user to view a virtual environment in 360 degrees and to interact with the environment using hand-tracking technology (i.e., when a user's hand is projected into the virtual world to be used for interactions and gestures). | Other: Virtual reality<br>* A role-playing game with activities based on existing therapy activities (such as orientation therapy, reminiscence therapy, art therapy, and music therapy) that are used to manage behavioral and psychological symptoms of dementia<br>|
| Experimental: Semi-cave automatic virtual environment (semi-CAVE)<br>The semi-CAVE system uses projectors and projector screens to provide a 270-degree view of the virtual environment. These projectors are connected to a powerful workstation (desktop computer), which uses HTC Vive trackers and base stations to track user movements and interactions | Other: Virtual reality<br>* A role-playing game with activities based on existing therapy activities (such as orientation therapy, reminiscence therapy, art therapy, and music therapy) that are used to manage behavioral and psychological symptoms of dementia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory-12 | The NPI evaluates the degree and severity of BPSDs and the distress it causes the primary caregiver. Scores range from 0 to 120 where higher scores indicate greater psychiatric disturbance. | Within one hour after completion of the fourth session | 
| Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire | The VRSQ will measure a participant's experience with the following symptoms: general discomfort, fatigue, eye strain, difficulty focusing, headache, fullness of head, blurring of vision, dizziness (when eyes are closed), and vertigo. Symptoms will be rated on a 4-point scale: 0 or None, 1 or Slight, 2 or Moderate, and 3 or Severe. | Immediately after each intervention, within an hour of completion of the virtual reality game | 
| Usability of the virtual reality intervention will be assessed using the System Usability Scale | The SUS is a 10-item questionnaire that is widely used in the evaluation of various kinds and aspects of technology. Each question has five response options ranging from 'Strongly agree' to 'Strongly disagree', which has a corresponding number value. Each response is added and multiplied by 2.5 to obtain the final score that ranges from 0 to 100. A SUS score above 68 is considered above average. | Immediately after each intervention, within an hour of completion of the virtual reality game | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function will be assessed using MOCA-P | Montreal Cognitive Assessment-Philippines (MOCA-P) is a 30-item test that takes about 10-12 minutes to complete. The test measures different cognitive domains such as visuospatial/executive, naming, memory, attention, language, abstraction, and orientation. | Within one hour after completion of the fourth session | 
| Cognitive function will be assessed using MMSE | The Mini-Mental State Exam (MMSE) is a 30-item test for cognitive function. It assesses attention, orientation, memory, registration, recall, calculation, language, and an individual's ability to draw a complex polygon. | Within one hour after completion of the fourth session | 
| Cognitive function will be assessed using ADAS-Cog | The cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) is an 11-item tool for the assessment of the following tasks: word recall, naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, and language. | Within one hour after completion of the fourth session | 
| Activities of daily living will be assessed using ADCS-ADL | The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) is a 24-item assessment on activities of daily living within the past four weeks | Within one hour after completion of the fourth session | 
| Health-related quality of life will be assessed using DEMQOL | The Health-related quality of life for people with dementia (DEMQOL) is a 28-item self-report measure of quality of life specific for persons with mild-to-moderate dementia. It covers four dimensions of quality of life, namely, daily activities, memory, negative emotion, and positive emotion. | Within one hour after completion of the fourth session |