Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders

NCT06597591 | Recruiting

• 2 other identifiers: 24-PP-06 VR4ICNuméro ID RCB: 2024-A01142-45
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Disorder

Keywords

inhibitory control; serious game; virtual reality; cognitive disorder

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

Serious game on VR headset ( immersive VR)

EXPERIMENTAL

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

Serious game on tablet ( non Immersive VR)

EXPERIMENTAL

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

Waiting Serious game on VR headset (Waiting immersive VR)

EXPERIMENTAL

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

Waiting Serious game on tablet ( Waiting non Immersive VR)

EXPERIMENTAL

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

Interventions

VR headset DEVICE

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.

Serious game on VR headset ( immersive VR); Waiting Serious game on VR headset (Waiting immersive VR)

Tablet DEVICE

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.

Serious game on tablet ( non Immersive VR); Waiting Serious game on tablet ( Waiting non Immersive VR)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Guillaume SACCO, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lemaire Justine

CONTACT

+330492034778; lemaire.j@chu-nice.fr

Study Design

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

Model Details: Pseudo-randomisation (controlling for demographic and clinical features, and previous VR experience)

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): May 18, 2027
• Study Completion (Estimated): November 18, 2027
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)