ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia

NCT05265182 | Completed

• 1 other identifier: AXEL0001
• 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 first phase. The phase 1 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population.

Conditions

Dementia Alzheimers

Outcome Measures

Primary Outcomes (3)

• The incidence of cybersickness will be assessed using the Virtual Reality Sickness Questionnaire.

  A 9-item Virtual Reality Sickness Questionnaire to assess cybersickness.

  Immediately after each intervention, within an hour of completion of the virtual reality game.

• The acceptability of the design will be measured using the Place Probe.

  The Place Probe is a sense of place questionnaire.

  Immediately after each intervention, within an hour of completion of the virtual reality game.

• The rate of usability will be performed according to the Philippine National Standards ISO/IEC Metrics.

  The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction.

  Within an hour of the end of the study.

Study Arms (2)

Semi-CAVE

EXPERIMENTAL

The Semi-CAVE (Figure 2) will use two screens positioned at a corner of the room, each with a ceiling-mounted short throw projector in front. The user will sit in the middle of the area, giving them a viewing angle of roughly 180 degrees. The user will interact with the system through motion sensors positioned at the corners of the area. To one side of the area will be a sufficiently powerful computer running the software. The projectors will be connected to this computer via HDMI cables or similar. The Semi-CAVE may be offered as a solution for rehabilitation centers.

Procedure: virtual reality

Head-mounted display or HMD

EXPERIMENTAL

The HMD will be a commercially available device that uses handheld controllers in addition to the head mounted apparatus, to control movement while in the VE. This device could provide a cheaper, more practical alternative to patients with mobility issues and environmental limitations brought about by the pandemic, since this can be used at home. Any patient, with supervision from their caregivers, will be able to use the applications using only the HMD system.

Procedure: virtual reality

Interventions

virtual reality PROCEDURE

Create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population initially, using semi-Cave or head-mounted display.

Head-mounted display or HMD; Semi-CAVE

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 40 to 59 years old
• Montreal Cognitive Assessment-Philippine Version (MoCA-P) score \> 20
• Neuropsychiatric Inventory (NPI) score of 0
• Able to understand Filipino and English

You may not qualify if:

• Previously diagnosed with dementia
• Receptive aphasia
• Previously diagnosed with a psychiatric disorder
• Previously diagnosed with seizures or epilepsy
• Significant visual and hearing impairment
• Has a history of motion sickness
• Quadriplegia or paralysis of dominant hand
• Life expectancy of less than a year

Sponsors & Collaborators

• Augmented eXperience E-health Laboratory: lead

Study Sites (1)

College of Allied Medical Professions Clinic for Therapy Services

Manila, National Capital Region, 1000, Philippines

Location

Related Publications (18)

• Appel L, Kisonas E, Appel E, Klein J, Bartlett D, Rosenberg J, Smith CN. Administering Virtual Reality Therapy to Manage Behavioral and Psychological Symptoms in Patients With Dementia Admitted to an Acute Care Hospital: Results of a Pilot Study. JMIR Form Res. 2021 Feb 3;5(2):e22406. doi: 10.2196/22406.

  PMID: 33533720 BACKGROUND

• Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

  PMID: 23961782 BACKGROUND

• Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.

  PMID: 30702436 BACKGROUND

• Clay F, Howett D, FitzGerald J, Fletcher P, Chan D, Price A. Use of Immersive Virtual Reality in the Assessment and Treatment of Alzheimer's Disease: A Systematic Review. J Alzheimers Dis. 2020;75(1):23-43. doi: 10.3233/JAD-191218.

  PMID: 32280091 BACKGROUND

• Coelho T, Marques C, Moreira D, Soares M, Portugal P, Marques A, Ferreira AR, Martins S, Fernandes L. Promoting Reminiscences with Virtual Reality Headsets: A Pilot Study with People with Dementia. Int J Environ Res Public Health. 2020 Dec 12;17(24):9301. doi: 10.3390/ijerph17249301.

  PMID: 33322679 BACKGROUND

• Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.

  PMID: 9153155 BACKGROUND

• Dominguez JC, Orquiza MG, Soriano JR, Magpantay CD, Esteban RC, Corrales ML, Ampil ER. Adaptation of the Montreal Cognitive Assessment for elderly Filipino patients. East Asian Arch Psychiatry. 2013 Sep;23(3):80-5.

  PMID: 24088400 BACKGROUND

• Dominguez J, Fe de Guzman M, Reandelar M, Thi Phung TK. Prevalence of Dementia and Associated Risk Factors: A Population-Based Study in the Philippines. J Alzheimers Dis. 2018;63(3):1065-1073. doi: 10.3233/JAD-180095.

  PMID: 29710725 BACKGROUND

• Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral and psychological symptoms of dementia. BMJ. 2015 Mar 2;350:h369. doi: 10.1136/bmj.h369.

  PMID: 25731881 BACKGROUND

• Kim O, Pang Y, Kim JH. The effectiveness of virtual reality for people with mild cognitive impairment or dementia: a meta-analysis. BMC Psychiatry. 2019 Jul 12;19(1):219. doi: 10.1186/s12888-019-2180-x.

  PMID: 31299921 BACKGROUND

• Wong WT, Tan NC, Lim JE, Allen JC Jr, Lee WS, Quah JHM, Paulpandi M, Teh TA, Lim SH, Malhotra R. Comparison of Time Taken to Assess Cognitive Function Using a Fully Immersive and Automated Virtual Reality System vs. the Montreal Cognitive Assessment. Front Aging Neurosci. 2021 Nov 23;13:756891. doi: 10.3389/fnagi.2021.756891. eCollection 2021.

  PMID: 34887743 BACKGROUND

• Manera V, Chapoulie E, Bourgeois J, Guerchouche R, David R, Ondrej J, Drettakis G, Robert P. A Feasibility Study with Image-Based Rendered Virtual Reality in Patients with Mild Cognitive Impairment and Dementia. PLoS One. 2016 Mar 18;11(3):e0151487. doi: 10.1371/journal.pone.0151487. eCollection 2016.

  PMID: 26990298 BACKGROUND

• Mendez MF, Joshi A, Jimenez E. Virtual reality for the assessment of frontotemporal dementia, a feasibility study. Disabil Rehabil Assist Technol. 2015 Mar;10(2):160-4. doi: 10.3109/17483107.2014.889230. Epub 2014 Feb 14.

  PMID: 24524440 BACKGROUND

• Moyle W, Jones C, Dwan T, Petrovich T. Effectiveness of a Virtual Reality Forest on People With Dementia: A Mixed Methods Pilot Study. Gerontologist. 2018 May 8;58(3):478-487. doi: 10.1093/geront/gnw270.

  PMID: 28329867 BACKGROUND

• Optale G, Urgesi C, Busato V, Marin S, Piron L, Priftis K, Gamberini L, Capodieci S, Bordin A. Controlling memory impairment in elderly adults using virtual reality memory training: a randomized controlled pilot study. Neurorehabil Neural Repair. 2010 May;24(4):348-57. doi: 10.1177/1545968309353328. Epub 2009 Nov 24.

  PMID: 19934445 BACKGROUND

• Strong J. Immersive Virtual Reality and Persons with Dementia: A Literature Review. J Gerontol Soc Work. 2020 Apr;63(3):209-226. doi: 10.1080/01634372.2020.1733726. Epub 2020 Feb 24.

  PMID: 32091323 BACKGROUND

• Thapa N, Park HJ, Yang JG, Son H, Jang M, Lee J, Kang SW, Park KW, Park H. The Effect of a Virtual Reality-Based Intervention Program on Cognition in Older Adults with Mild Cognitive Impairment: A Randomized Control Trial. J Clin Med. 2020 Apr 29;9(5):1283. doi: 10.3390/jcm9051283.

  PMID: 32365533 BACKGROUND

• White PJ, Moussavi Z. Neurocognitive Treatment for a Patient with Alzheimer's Disease Using a Virtual Reality Navigational Environment. J Exp Neurosci. 2016 Nov 8;10:129-135. doi: 10.4137/JEN.S40827. eCollection 2016.

  PMID: 27840579 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HMD and Semi-Cave

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: March 3, 2022
• Study Start: April 28, 2022
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: February 1, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)