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

Augmented eXperience E-health Laboratory

Status: Enrolling

Conditions: Dementia Alzheimers

Treatments: Other: Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06072014

AXEL0003

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Head-mounted display (HMD)

Experimental group

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).

Treatment:

Other: Virtual reality

Semi-cave automatic virtual environment (semi-CAVE)

Experimental group

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

Treatment:

Other: Virtual reality