search
Back to results

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

Primary Purpose

Dementia Alzheimers

Status
Recruiting
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
Augmented eXperience E-health Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia Alzheimers

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of the Philippines College of Allied Medical Professions Immersive Technology LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Head-mounted display (HMD)

Semi-cave automatic virtual environment (semi-CAVE)

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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
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.

Full Information

First Posted
September 28, 2023
Last Updated
October 5, 2023
Sponsor
Augmented eXperience E-health Laboratory
search

1. Study Identification

Unique Protocol Identification Number
NCT06072014
Brief Title
ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia (Phase 2)
Official Title
Developing Immersive Gamification Technology Systems for the Management of Patients With Alzheimer's Disease With Behavioral and Psychological Symptoms of Dementia (Phase 2 Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augmented eXperience E-health Laboratory

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Alzheimers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Head-mounted display (HMD)
Arm Type
Experimental
Arm Description
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).
Arm Title
Semi-cave automatic virtual environment (semi-CAVE)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
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 Outcome Measure Information:
Title
Incidence of behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory-12
Description
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
Title
Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire
Description
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
Title
Usability of the virtual reality intervention will be assessed using the System Usability Scale
Description
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 Outcome Measure Information:
Title
Cognitive function will be assessed using MOCA-P
Description
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
Title
Cognitive function will be assessed using MMSE
Description
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
Title
Cognitive function will be assessed using ADAS-Cog
Description
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
Title
Activities of daily living will be assessed using ADCS-ADL
Description
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
Title
Health-related quality of life will be assessed using DEMQOL
Description
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 Pre-specified Outcome Measures:
Title
Acceptability
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roland Dominic G. Jamora, MD, PhD
Phone
+639985438062
Email
rgjamora@up.edu.ph
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veeda Michelle M. Anlacan, MD
Organizational Affiliation
University of the Philippines Manila
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory
City
City Of Manila
State/Province
National Capital Region
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Eliza R. Aguila, PhD
Phone
+639178212563
Email
mraguila1@up.edu.ph

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs