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

NCT ID: NCT06072014

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2023-12-31

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.

Conditions

Dementia Alzheimers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Augmented eXperience E-health Laboratory

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veeda Michelle M. Anlacan, MD

Role: PRINCIPAL_INVESTIGATOR

University of the Philippines Manila

Locations

University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory

Manila, National Capital Region, Philippines

Site Status: RECRUITING

Countries

Philippines

Central Contacts

Roland Dominic G. Jamora, MD, PhD

Role: CONTACT

rgjamora@up.edu.ph

+639985438062

Facility Contacts

Maria Eliza R. Aguila, PhD

Role: primary

mraguila1@up.edu.ph

+639178212563

References

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

Reference Type: BACKGROUND

Other Identifiers

AXEL0003

Identifier Type: -

Identifier Source: org_study_id