Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders

Not Applicable

Recruiting

• Conditions: Cognitive Disorder
• Interventions: Device: Tablet; Device: VR headset

• Registration Number: NCT06597591
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Study Start: 2024-11-18
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2027-05-18
• Study Completion: 2027-11-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serious game on tablet ( non Immersive VR)	Tablet	After enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game on a tablet.
Serious game on VR headset ( immersive VR)	VR headset	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.
Waiting Serious game on VR headset (Waiting immersive VR)	VR headset	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.
Waiting Serious game on tablet ( Waiting non Immersive VR)	Tablet	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.

Primary Outcome Measures

Name	Time	Method
Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire	at inclusion	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.
UTAUT 2 Questionnaire	at 24-week	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.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France