Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 4 treatment groups
Group A: Serious game on VR headset ( immersive VR)Experimental treatment 1 intervention
Group B: Serious game on tablet ( non Immersive VR)Experimental treatment 1 intervention
Group C: Waiting Serious game on VR headset (Waiting immersive VR)Experimental treatment 1 intervention
Group D: Waiting Serious game on tablet ( Waiting non Immersive VR)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
at inclusion
2

UTAUT 2 Questionnaire

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.

Time frame
at 4-week
3

UTAUT 2 Questionnaire

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.

Time frame
at 8-week
4

UTAUT 2 Questionnaire

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.

Time frame
at 16-week

Secondary outcomes

Other outcomes

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