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Recruiting NCT06597591

Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders

No phase Interventional Cognitive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR headset, Tablet.
Who it may be relevant to
Registry conditions: Cognitive Disorder. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 witho
  • 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 s

Primary outcome measures

  • Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire [Time frame: at inclusion]
  • UTAUT 2 Questionnaire [Time frame: at 4-week]
  • UTAUT 2 Questionnaire [Time frame: at 8-week]
  • UTAUT 2 Questionnaire [Time frame: at 16-week]
  • UTAUT 2 Questionnaire [Time frame: at 20-week]
  • UTAUT 2 Questionnaire [Time frame: at 24-week]

Eligibility criteria

Inclusion criteria

  • consulting the Nice hospital Memory Center
  • diagnosis of Mild Neurocognitve Disorder or slight major neurocognitive disorder (DSM V)
  • 60 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Nice — Nice

Identifiers

NCT: NCT06597591 · 24-PP-06 VR4IC · Numéro ID RCB: 2024-A01142-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗