Healthy VolunteersLABLifeNCT06337500
Validation of a Making Decision Hybrid (Ecologic and Virtual) Task
A study testing Neurophysiological measure (EEG) and Survey in people with Healthy Volunteers and Behavior and Behavior Mechanisms, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the "hybrid" task and the "virtual" task will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Behavior and Behavior Mechanisms
- What is being tested?
- Neurophysiological measure (EEG) and Survey
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2024to 1 Jun 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 65 inclusive
- Subjects with no neurological or psychiatric disorders
- Subjects with no addictive disorder except tobacco
- Signed informed consent indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the requirements and restrictions inherent in the study
- Affiliation with a French social security scheme or beneficiary of such a scheme.
Who cannot join
- Men and women under 18 or over 65 years of age
- Subjects suffering from a neurological or psychiatric disorder
- Subjects suffering from an addictive disorder, with the exception of tobacco
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
- Subject without health insurance
- Pregnant
- Subject within the exclusion period of another study or on the "national volunteer list".
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 Besançon
Besançon, Not in US/Canada
Karine Charrière, +33381218999, kcharriere@chu-besancon.fr
About this study
The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the "hybrid" task and the "virtual" task will be evaluated.
- Being tested
- Neurophysiological measure (EEG), Survey
- Keywords
- decision-making, ecological task, brain activity
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurophysiological measure (EEG)Device
Cerebral electric activity recorded with EEG
SurveyOther
Participants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed
| Study group | Role | What they receive |
|---|---|---|
| Iowa Gambling Task - ecologic | Experimental | The participant performs the card selection task in its ecological version (with real cards). Receives: Other: Survey |
| Iowa Gambling Task - virtual | Active comparator | The participant performs the card selection task in its virtual version (computer task). Receives: Device: Neurophysiological measure (EEG); Other: Survey |
| Iowa Gambling Task - hybrid | Experimental | The participant performs the card selection task thanks to our homemade interface "LAB-Life". Receives: Device: Neurophysiological measure (EEG); Other: Survey |
| Game of Dice Task - ecologic | Experimental | The participant performs the dice-rolling task in its ecological version (with real dices). Receives: Other: Survey |
| Game of Dice Task - virtual | Active comparator | The participant performs the dice-rolling task in its virtual version (computer task) Receives: Device: Neurophysiological measure (EEG); Other: Survey |
| Game of Dice Task - hybrid | Experimental | The participant performs the dice-rolling task thanks to our homemade interface "LAB-Life". Receives: Device: Neurophysiological measure (EEG); Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the homemade "Lab-Life" interface as a tool for simulating an ecological task with sufficient fidelity, while meeting the conditions required for recording high-quality brain activity using an EEG-HR.
Behavioral score obtained after completion of the hybrid task (netscore obtained at the IGT). This score can be compared with the scores obtained after the ecological and virtual tasks.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie GIUSTINIANI, MD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337500
- Sponsor's protocol ID
- 2023/764
- Acronym
- LABLife
- Status last verified
- Jul 2025
- First submitted
- 15 Mar 2024
- Last updated
- 18 Jul 2025
- 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Making Decision Hybrid (Ecologic and Virtual) Task
- ClinicalTrials.gov ID
- NCT06337500
- Acronym / sponsor ID
- LABLife / 2023/764
- Keywords
- decision-making, ecological task, brain activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 29 Mar 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.
The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the "hybrid" task and the "virtual" task will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Iowa Gambling Task - ecologic | Experimental | Other: SurveyThe participant performs the card selection task in its ecological version (with real cards). |
| Iowa Gambling Task - virtual | Active comparator | Device: Neurophysiological measure (EEG), Other: SurveyThe participant performs the card selection task in its virtual version (computer task). |
| Iowa Gambling Task - hybrid | Experimental | Device: Neurophysiological measure (EEG), Other: SurveyThe participant performs the card selection task thanks to our homemade interface "LAB-Life". |
| Game of Dice Task - ecologic | Experimental | Other: SurveyThe participant performs the dice-rolling task in its ecological version (with real dices). |
| Game of Dice Task - virtual | Active comparator | Device: Neurophysiological measure (EEG), Other: SurveyThe participant performs the dice-rolling task in its virtual version (computer task) |
| Game of Dice Task - hybrid | Experimental | Device: Neurophysiological measure (EEG), Other: SurveyThe participant performs the dice-rolling task thanks to our homemade interface "LAB-Life". |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18 to 65 inclusive
- Subjects with no neurological or psychiatric disorders
- Subjects with no addictive disorder except tobacco
- Signed informed consent indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the requirements and restrictions inherent in the study
- Affiliation with a French social security scheme or beneficiary of such a scheme.
Key exclusion criteria (8 listed)
- Men and women under 18 or over 65 years of age
- Subjects suffering from a neurological or psychiatric disorder
- Subjects suffering from an addictive disorder, with the exception of tobacco
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
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 |
|---|---|---|
| Neurophysiological measure (EEG)Cerebral electric activity recorded with EEG | Device | Game of Dice Task - hybrid, Game of Dice Task - virtual, Iowa Gambling Task - hybrid, Iowa Gambling Task - virtual |
| SurveyParticipants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed | Other | Game of Dice Task - ecologic, Game of Dice Task - hybrid, Game of Dice Task - virtual, Iowa Gambling Task - ecologic, Iowa Gambling Task - hybrid, Iowa Gambling Task - virtual |
Primary outcome
Validation of the homemade "Lab-Life" interface as a tool for simulating an ecological task with sufficient fidelity, while meeting the conditions required for recording high-quality brain activity using an EEG-HR.
Time frame: Day 1
Behavioral score obtained after completion of the hybrid task (netscore obtained at the IGT). This score can be compared with the scores obtained after the ecological and virtual tasks.
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 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Julie GIUSTINIANI, MD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurophysiological measure (EEG) and Survey in people with Healthy Volunteers and Behavior and Behavior Mechanisms, run by Centre Hospitalier Universitaire de Besancon 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 5 inclusion and 8 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 Jul 2025. 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 Karine CHARRIERE, PhD (+333 81218999, kcharriere@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the homemade "Lab-Life" interface as a tool for simulating an ecological task with sufficient fidelity, while meeting the conditions required for recording high-quality brain activity using an EEG-HR. (time frame: Day 1). 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 Jul 2025.