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

Browse trials for

• Dementia 2,172
• Alzheimer Disease 3,675

Dementia

2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Lead sponsor

Augmented eXperience E-health Laboratory is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Study arms

• Experimental
  Head-mounted display (HMD)

  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

• Experimental
  Semi-cave automatic virtual environment (semi-CAVE)

  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

Interventions

• OtherVirtual reality

  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

Primary outcomes

1. 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.

   Time frame: Within one hour after completion of the fourth session

2. 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.

   Time frame: Immediately after each intervention, within an hour of completion of the virtual reality game

3. 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.

   Time frame: Immediately after each intervention, within an hour of completion of the virtual reality game

Secondary outcomes

1. 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.

   Time frame: Within one hour after completion of the fourth session

2. 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.

   Time frame: Within one hour after completion of the fourth session

3. 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.

   Time frame: Within one hour after completion of the fourth session

4. 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

   Time frame: Within one hour after completion of the fourth session

5. 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.

   Time frame: Within one hour after completion of the fourth session

Other outcomes

1. Acceptability

   Acceptability will be measured among a small group of patients and their caregivers through an interview and a focus group discussion

   Time frame: Within one day after completing virtual reality experience

Publications

• Anlacan, V.M.M. et al. (2023). Application Design for a Virtual Reality Therapy Game for Patients with Behavioral and Psychological Symptoms of Dementia. In: Krouska, A., Troussas, C., Caro, J. (eds) Novel & Intelligent Digital Systems: Proceedings of the 2nd International Conference (NiDS 2022). NiDS 2022. Lecture Notes in Networks and Systems, vol 556. Springer, Cham. https://doi.org/10.1007/978-3-031-17601-2_15