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

Dementia Alzheimers Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072014
• Other study ID #: AXEL0003
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Augmented eXperience E-health Laboratory
• Contact: Roland Dominic G. Jamora, MD, PhD
• Phone: +639985438062
• Email: rgjamora[@]up.edu.ph
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia Alzheimers

Intervention

Other:
• Virtual 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

Locations

Country	Name	City	State
Philippines	University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory	City Of Manila	National Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Augmented eXperience E-health Laboratory

Country where clinical trial is conducted

Philippines, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability	Acceptability will be measured among a small group of patients and their caregivers through an interview and a focus group discussion	Within one day after completing virtual reality experience
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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