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

NCT06072014 | Unknown

• 1 other identifier: AXEL0003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Cognitive function will be assessed using MOCA-P

  Within one hour after completion of the fourth session

• Cognitive function will be assessed using MMSE

  Within one hour after completion of the fourth session

• Cognitive function will be assessed using ADAS-Cog

  Within one hour after completion of the fourth session

• Activities of daily living will be assessed using ADCS-ADL

  Within one hour after completion of the fourth session

• Health-related quality of life will be assessed using DEMQOL

  Within one hour after completion of the fourth session

Other Outcomes (1)

• Acceptability

  Within one day after completing virtual reality experience

Study Arms (2)

Head-mounted display (HMD)

EXPERIMENTAL

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

Semi-cave automatic virtual environment (semi-CAVE)

EXPERIMENTAL

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

Virtual reality 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

Head-mounted display (HMD); Semi-cave automatic virtual environment (semi-CAVE)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Augmented eXperience E-health Laboratory: lead

Study Sites (1)

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

Manila, National Capital Region, 1000, Philippines

RECRUITING

Related 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

  BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Veeda Michelle M. Anlacan, MD

  University of the Philippines Manila

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Dominic G. Jamora, MD, PhD

CONTACT

+639985438062; rgjamora@up.edu.ph

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 10, 2023
• Study Start: July 10, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-09

Locations

PH (1)