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

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Cognitive Disorder

Treatments: Device: Tablet; Device: VR headset

Study type: Interventional

Funder types: Other

Identifiers

NCT06597591

24-PP-06 VR4IC

Numéro ID RCB: 2024-A01142-45 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Serious game on VR headset ( immersive VR)

Experimental group

Description:

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.

Treatment:

Device: VR headset

Serious game on tablet ( non Immersive VR)

Experimental group

Description:

After enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game on a tablet.

Treatment:

Device: Tablet

Waiting Serious game on VR headset (Waiting immersive VR)

Experimental group

Description:

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.

Treatment:

Device: VR headset

Waiting Serious game on tablet ( Waiting non Immersive VR)

Experimental group

Description:

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.

Treatment:

Device: Tablet