ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia
NCT ID: NCT05265182
Last Updated: 2023-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-04-28
2022-07-26
Brief Summary
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Detailed Description
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Demographic characteristics Demographic characteristics of the participant (age, sex, educational attainment, marital status, living conditions, hobbies and interests, previous experience with VE applications, existing illnesses, medications) will be collected by the researchers through a questionnaire. Personal data, such as name and contact information, will only be collected to allow the investigators to contact the participants, as needed.
Safety Safety will be ensured by assessing a participant's experience of cybersickness. A cybersickness questionnaire, the Virtual Reality Sickness Questionnaire will be administered after each session. In this self-report questionnaire, nine symptoms will be rated as absent/none, slight, moderate, or severe. These symptoms are general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness when the eyes are closed, and vertigo. Answering the questionnaire will take around 10 minutes.
In the event that a participant will experience severe cybersickness, they may opt to discontinue the experience. They will be instructed to remove the HMD or to step out of the Semi-CAVE room to rest and recover from the symptoms. A medical professional will be present to monitor the participant's symptoms and to attend to them for further management. The reason(s) for discontinuing the experience will be documented.
Acceptability The acceptability of the design will be measured using the Place Probe, a sense of place questionnaire. The questionnaire will be administered after each session, and it will collect information on a participant's experience in the VE application, particularly on (a) their general impression of the environment, (b) the key features of the environment, and (c) their feelings of presence. A positive general impression, a memorable environment, and high level of presence will indicate that the VE developed is acceptable. This will take about 10 minutes to complete.
Usability Usability testing will be performed according to the PNS 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. Additional usability metrics will be identified during the first phase of the study. The metrics will be specifically adjusted to the target participants as well as the contents to be included in the VR system.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Semi-CAVE
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.
virtual reality
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
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.
virtual reality
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.
Interventions
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virtual reality
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.
Eligibility Criteria
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Inclusion Criteria
* Montreal Cognitive Assessment-Philippine Version (MoCA-P) score \> 20
* Neuropsychiatric Inventory (NPI) score of 0
* Able to understand Filipino and English
Exclusion Criteria
* 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
40 Years
59 Years
ALL
Yes
Sponsors
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Augmented eXperience E-health Laboratory
OTHER
Responsible Party
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Principal Investigators
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Veeda Michelle M Anlacan, MD
Role: PRINCIPAL_INVESTIGATOR
University of the Philippines Manila
Locations
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College of Allied Medical Professions Clinic for Therapy Services
Manila, National Capital Region, Philippines
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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AXEL0001
Identifier Type: -
Identifier Source: org_study_id
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