Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders (VR4IC)

Acceptability of a VR-based Training for Inhibitory Control in Subjects With Neurocognitive Disorders

Executive function disorders, such as inhibitory control (IC) difficulties, are very common in older adults with neurocognitive disorders (NCD). Management of these disorders is possible using traditional tools and tools based on new technologies, such as serious games and virtual reality (VR). However, today, few immersive tools exist that are specifically focused on IC training. The present study aims to evaluate the acceptability of an immersive application focused on IC in 48 patients with neurocognitive disorders. Participants that will test either an immersive (VR-headset) or a non-immersive (tablet) version of the application for 4 weeks, twice a week, and fill-in acceptability related questionnaires before, during and after the end of the intervention.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Disorder
• Intervention / Treatment: Device: VR headset; Device: Tablet

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lemaire Justine; Phone Number: +330492034778; Email: lemaire.j@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Chu de Nice
    • Contact: Valérie Foussat; Phone Number: +330493034011; Email: foussat.v@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. consulting the Nice hospital Memory Center
2. diagnosis of Mild Neurocognitve Disorder or slight major neurocognitive disorder (DSM V)
3. 60 years old or more
4. presence of deficits in inhibitory control as assessed by the Frontal Assessment Battery
5. fluent in French
6. able to understand the informed consent form and voluntarily consents to participate

Exclusion Criteria:

1. presence of significant vision or motor problems which would impact ability to perform the task
2. significant self-reported motion sickness
3. vulnerable persons as defined in articles L1121-5 to 8 of the French Public Health Code

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Serious game on VR headset ( immersive VR); After enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a VR Headset.	Device: VR headset; 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a VR Headset. The serious game is inspired by the GoNoGo task.The players' task is to throw objects in a basket matching the active rule. These objects can be of three different colors (red, yellow, and purple) with the presence or absence of stains on them. The objects' color is hidden until the player interacts with them. Example of rule: the active rule is to throw in the basket only the objects in red without stains, yellow with stains, and purple with stains. To earn points, the player must match the rule presented and throw the objects away if they do not match.
Experimental: Serious game on tablet ( non Immersive VR); After enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game on a tablet.	Device: Tablet; 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a tablet. The serious game is inspired by the GoNoGo task.The players' task is to throw objects in a basket matching the active rule. These objects can be of three different colors (red, yellow, and purple) with the presence or absence of stains on them. The objects' color is hidden until the player interacts with them. Example of rule: the active rule is to throw in the basket only the objects in red without stains, yellow with stains, and purple with stains. To earn points, the player must match the rule presented and throw the objects away if they do not match.
Experimental: Waiting Serious game on VR headset (Waiting immersive VR); 2-month after enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a VR Headset.	Device: VR headset; 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a VR Headset. The serious game is inspired by the GoNoGo task.The players' task is to throw objects in a basket matching the active rule. These objects can be of three different colors (red, yellow, and purple) with the presence or absence of stains on them. The objects' color is hidden until the player interacts with them. Example of rule: the active rule is to throw in the basket only the objects in red without stains, yellow with stains, and purple with stains. To earn points, the player must match the rule presented and throw the objects away if they do not match.
Experimental: Waiting Serious game on tablet ( Waiting non Immersive VR); 2-month after enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a VR Headset.	Device: Tablet; 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a tablet. The serious game is inspired by the GoNoGo task.The players' task is to throw objects in a basket matching the active rule. These objects can be of three different colors (red, yellow, and purple) with the presence or absence of stains on them. The objects' color is hidden until the player interacts with them. Example of rule: the active rule is to throw in the basket only the objects in red without stains, yellow with stains, and purple with stains. To earn points, the player must match the rule presented and throw the objects away if they do not match.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire	Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology. The UTAUT2 questionnaire contains 25 questions and evaluates variables including Performance Expectancy, Effort Expectancy, Social Influence, Facility Conditions.. Each question is measured using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate a better outcome, reflecting greater acceptance and intention to use the technology.	at inclusion
UTAUT 2 Questionnaire	Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology. The UTAUT2 questionnaire contains 25 questions and evaluates variables including Performance Expectancy, Effort Expectancy, Social Influence, Facility Conditions. Each question is measured using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate a better outcome, reflecting greater acceptance and intention to use the technology.	at 4-week
UTAUT 2 Questionnaire	Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology. The UTAUT2 questionnaire contains 25 questions and evaluates variables including Performance Expectancy, Effort Expectancy, Social Influence, Facility Conditions.. Each question is measured using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate a better outcome, reflecting greater acceptance and intention to use the technology.	at 8-week
UTAUT 2 Questionnaire	Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology. The UTAUT2 questionnaire contains 25 questions and evaluates variables including Performance Expectancy, Effort Expectancy, Social Influence, Facility Conditions.. Each question is measured using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate a better outcome, reflecting greater acceptance and intention to use the technology.	at 16-week
UTAUT 2 Questionnaire	Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology. The UTAUT2 questionnaire contains 25 questions and evaluates variables including Performance Expectancy, Effort Expectancy, Social Influence, Facility Conditions.. Each question is measured using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate a better outcome, reflecting greater acceptance and intention to use the technology.	at 20-week
UTAUT 2 Questionnaire	Questionnaire of acceptability / acceptance of the tool and its use by professionals based on the Unified Theory of Acceptance and Use Technology. The UTAUT2 questionnaire contains 25 questions and evaluates variables including Performance Expectancy, Effort Expectancy, Social Influence, Facility Conditions. Each question is measured using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate a better outcome, reflecting greater acceptance and intention to use the technology.	at 24-week

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Guillaume SACCO, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): May 18, 2027
• Study Completion (Estimated): November 18, 2027

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: virtual reality; serious game; inhibitory control; cognitive disorder
• Additional Relevant MeSH Terms: Mental Disorders; Cognitive Dysfunction; Neurocognitive Disorders; Cognition Disorders
• Other Study ID Numbers: 24-PP-06 VR4IC; Numéro ID RCB: 2024-A01142-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No