Cognitive DisorderVR4ICNCT06597591
Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders
A study testing VR headset and Tablet in people with Cognitive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Disorder
- What is being tested?
- VR headset and Tablet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2024to 18 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, 06000
Valérie Foussat, +330493034011, foussat.v@chu-nice.fr
About this study
Official title: Acceptability of a VR-based Training for Inhibitory Control in Subjects With 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.
- Conditions
- Cognitive Disorder
- Being tested
- VR headset, Tablet
- Keywords
- inhibitory control, serious game, virtual reality, cognitive disorder
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR headsetDevice
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.
TabletDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Serious game on VR headset ( immersive VR) | Experimental | 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. Receives: Device: VR headset |
| Serious game on tablet ( non Immersive VR) | Experimental | After enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game on a tablet. Receives: Device: Tablet |
| Waiting Serious game on VR headset (Waiting immersive VR) | Experimental | 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. Receives: Device: VR headset |
| Waiting Serious game on tablet ( Waiting non Immersive VR) | Experimental | 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. Receives: Device: Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion
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.
Measured: at 4-week
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.
Measured: at 8-week
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.
Measured: at 16-week
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.
Measured: at 20-week
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.
Measured: at 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Nov 2024
- Primary completion18 May 2027 (estimated)
- Study completion18 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pseudo-randomisation (controlling for demographic and clinical features, and previous VR experience)
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie MOUTON, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597591
- Sponsor's protocol ID
- 24-PP-06 VR4IC
- Other IDs
- Numéro ID RCB: 2024-A01142-45
- Acronym
- VR4IC
- Status last verified
- Jun 2026
- First submitted
- 5 Sep 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of a VR-based Training for Inhibitory Control in Subjects With Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT06597591
- Acronym / sponsor ID
- VR4IC / 24-PP-06 VR4IC
- Conditions
- Cognitive Disorder
- Keywords
- inhibitory control, serious game, virtual reality, cognitive disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 18 May 2027 (estimated)
- Study completion
- 18 Nov 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Pseudo-randomisation (controlling for demographic and clinical features, and previous VR experience)
| Arm | Type | Receives |
|---|---|---|
| Serious game on VR headset ( immersive VR) | Experimental | Device: VR headsetAfter enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game with a VR Headset. |
| Serious game on tablet ( non Immersive VR) | Experimental | Device: TabletAfter enrolment, patients will have 8 sessions (2 times per week for 4 weeks) of 20 minutes playing the serious game on a tablet. |
| Waiting Serious game on VR headset (Waiting immersive VR) | Experimental | Device: VR headset2-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. |
| Waiting Serious game on tablet ( Waiting non Immersive VR) | Experimental | Device: Tablet2-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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR headset8 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. | Device | Serious game on VR headset ( immersive VR), Waiting Serious game on VR headset (Waiting immersive VR) |
| Tablet8 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. | Device | Serious game on tablet ( non Immersive VR), Waiting Serious game on tablet ( Waiting non Immersive VR) |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cognitive Disorder
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruitingObservational study
MCR Syndrome in Quebec : Results From NuAge Study
Motoric Cognitive Risk Syndrome, Aging Disorder
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurélie MOUTON, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR headset and Tablet in people with Cognitive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lemaire Justine (+330492034778, lemaire.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire (time frame: at inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.