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NCT Number: NCT06597591

Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders

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.

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Key information

Conditions

Cognitive Disorder Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire

    Time frame: 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.

  2. UTAUT 2 Questionnaire

    Time frame: at 4-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.

  3. UTAUT 2 Questionnaire

    Time frame: at 8-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.

  4. UTAUT 2 Questionnaire

    Time frame: at 16-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.

  5. UTAUT 2 Questionnaire

    Time frame: at 20-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.

  6. UTAUT 2 Questionnaire

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lemaire Justine

CONTACT

[email protected]

+330492034778

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: VR4IC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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