Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention

The Methodist Hospital Research Institute30 enrolled

Overview

This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers.

Virtual reality (VR) imitates reality by creating an artificial 3-D environment using computing technology or software. Using this software with a headset, a virtual environment is created, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a virtual environment allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled virtual environment. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. This trial aims to follow in similar footsteps using the gamification of exercises for cognitive stimulation in healthy volunteers to record outcomes and perform usability testing. These exercise "games" allow users to focus and pay attention to the game while helping reorient and cognitively stimulate the user's brain. The games are built with increasing difficulty and complexity of user demand and output. A novel, 3D-simulated software platform prototype called ''ReCognitionVR'' was developed to provide VR-based cognitive exercises to healthy participants for testing. The premise of this trial is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed- environment with music. According to our institutional review board recommendations, this pilot study will be conducted in two steps on two different cohorts which are as follows: In the first step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercises will be evaluated on elderly healthy subjects. This study's results will inform the design of a second-step pilot study. In the second step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercise will be evaluated for elderly surgical patients who are at high risk for the development of delirium.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Virtual Reality

Interventions

Virtual Reality SoftwareOTHER

The ReCognition virtual reality software is delivered via an Oculus Quest 2 device. This three-dimensional simulated software was designed to improve attention and executive functions.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-35 years or ≥60 years * Healthy volunteers who meet one of the following criteria according to their self-reported medical history: 1. American Society of Anesthesiologists (ASA) 1: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance. 2. ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (eg, treated hypertension, obesity with BMI under 35, frequent social drinker, but is nonsmoking). Exclusion Criteria: * Age \<18 years; 36-59 years * Person with active psychiatric disorders, especially schizophrenia * Person who is deaf or blind

Locations (1)

Houston Methodist Research Institute

Houston, Texas, United States

Outcomes

Primary Outcomes

Percentage of Participants Using Virtual Reality Software at 20 Minutes After Start

Whether 70% of participants in each group will complete 20 minutes of use of the ReCognition VR-based software (a binary outcome)

Time frame: 20 minutes after the start of software use

Secondary Outcomes

Participants With a System Usability Scale Score >35

The proportion of participants with a System Usability Scale score \>35 on a scale of 0-100, where higher scores mean better usability.

Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use

Participant High Score in Easy Mode

Participant highest score achieved utilizing the virtual reality software, on a scale of 0 to 100, where higher scores indicate better performance in the software game.

Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use

Participant High Score in Medium Difficulty Mode

Participant highest score achieved utilizing the virtual reality software, on a scale of 0 to 100, where higher scores indicate better performance in the software game.

Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use

Participant High Score in Hard Mode

Participant highest score achieved utilizing the virtual reality software, on a scale of 0 to 100, where higher scores indicate better performance in the software game.

Time frame: After completion of use of the virtual reality software, up to 2 hours after the start of software use

Change From Baseline in Heart Rate After 10 Minutes of Virtual Reality Software Use

Data from ClinicalTrials.gov

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