Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders

NCT ID: NCT06597591

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2027-11-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VR headset

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Tablet

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

VR headset

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Tablet

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume SACCO, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Nice

Nice, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lemaire Justine

Role: CONTACT

lemaire.j@chu-nice.fr

+330492034778

Facility Contacts

Valérie Foussat

Role: primary

foussat.v@chu-nice.fr

+330493034011

Other Identifiers

Numéro ID RCB: 2024-A01142-45

Identifier Type: OTHER

Identifier Source: secondary_id

24-PP-06 VR4IC

Identifier Type: -

Identifier Source: org_study_id