ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia

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 first phase. The phase 1 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population.

Detailed Description
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The participants will undergo an intervention using the assigned ImGTS for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. VR trials are in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort. During the experience, documentation of the patient's reaction and interaction with the ImGTS will be recorded by the researchers. The participants will be staying at the designated laboratory for not more than one hour. Demographic characteristics Demographic characteristics of the participant (age, sex, educational attainment, marital status, living conditions, hobbies and interests, previous experience with VE applications, existing illnesses, medications) will be collected by the researchers through a questionnaire. Personal data, such as name and contact information, will only be collected to allow the investigators to contact the participants, as needed. Safety Safety will be ensured by assessing a participant's experience of cybersickness. A cybersickness questionnaire, the Virtual Reality Sickness Questionnaire will be administered after each session. In this self-report questionnaire, nine symptoms will be rated as absent/none, slight, moderate, or severe. These symptoms are general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness when the eyes are closed, and vertigo. Answering the questionnaire will take around 10 minutes. In the event that a participant will experience severe cybersickness, they may opt to discontinue the experience. They will be instructed to remove the HMD or to step out of the Semi-CAVE room to rest and recover from the symptoms. A medical professional will be present to monitor the participant's symptoms and to attend to them for further management. The reason(s) for discontinuing the experience will be documented. Acceptability The acceptability of the design will be measured using the Place Probe, a sense of place questionnaire. The questionnaire will be administered after each session, and it will collect information on a participant's experience in the VE application, particularly on (a) their general impression of the environment, (b) the key features of the environment, and (c) their feelings of presence. A positive general impression, a memorable environment, and high level of presence will indicate that the VE developed is acceptable. This will take about 10 minutes to complete. Usability Usability testing will be performed according to the PNS ISO/IEC Metrics. The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction. Additional usability metrics will be identified during the first phase of the study. The metrics will be specifically adjusted to the target participants as well as the contents to be included in the VR system.

Official Title
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Developing an Immersive Gamification Technology System (ImGTS) for the Management of Patients With Behavioral and Psychological Symptoms of Dementia (Phase 1 Trial)

Conditions
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Dementia Alzheimers

Intervention / Treatment
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* Procedure: virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40 to 59 years old Montreal Cognitive Assessment-Philippine Version (MoCA-P) score > 20 Neuropsychiatric Inventory (NPI) score of 0 Able to understand Filipino and English Exclusion Criteria: Previously diagnosed with dementia Receptive aphasia Previously diagnosed with a psychiatric disorder Previously diagnosed with seizures or epilepsy Significant visual and hearing impairment Has a history of motion sickness Quadriplegia or paralysis of dominant hand Life expectancy of less than a year

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: HMD and Semi-Cave
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semi-CAVE<br>The Semi-CAVE (Figure 2) will use two screens positioned at a corner of the room, each with a ceiling-mounted short throw projector in front. The user will sit in the middle of the area, giving them a viewing angle of roughly 180 degrees. The user will interact with the system through motion sensors positioned at the corners of the area. To one side of the area will be a sufficiently powerful computer running the software. The projectors will be connected to this computer via HDMI cables or similar. The Semi-CAVE may be offered as a solution for rehabilitation centers. | Procedure: virtual reality<br>* Create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population initially, using semi-Cave or head-mounted display.<br>|
| Experimental: Head-mounted display or HMD<br>The HMD will be a commercially available device that uses handheld controllers in addition to the head mounted apparatus, to control movement while in the VE. This device could provide a cheaper, more practical alternative to patients with mobility issues and environmental limitations brought about by the pandemic, since this can be used at home. Any patient, with supervision from their caregivers, will be able to use the applications using only the HMD system. | Procedure: virtual reality<br>* Create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population initially, using semi-Cave or head-mounted display.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of cybersickness will be assessed using the Virtual Reality Sickness Questionnaire. | A 9-item Virtual Reality Sickness Questionnaire to assess cybersickness. | Immediately after each intervention, within an hour of completion of the virtual reality game. | 
| The acceptability of the design will be measured using the Place Probe. | The Place Probe is a sense of place questionnaire. | Immediately after each intervention, within an hour of completion of the virtual reality game. | 
| The rate of usability will be performed according to the Philippine National Standards ISO/IEC Metrics. | The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction. | Within an hour of the end of the study. |