Validation of a Making Decision Hybrid (Ecologic and Virtual) Task (LABLife)

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 Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers; Behavior and Behavior Mechanisms
• Intervention / Treatment: Other: Survey; Device: Neurophysiological measure (EEG)

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karine CHARRIERE, PhD; Phone Number: +333 81218999; Email: kcharriere@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iowa Gambling Task - ecologic; The participant performs the card selection task in its ecological version (with real cards).	Other: Survey; Participants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed
Active Comparator: Iowa Gambling Task - virtual; The participant performs the card selection task in its virtual version (computer task).	Other: Survey; Participants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed; Device: Neurophysiological measure (EEG); Cerebral electric activity recorded with EEG
Experimental: Iowa Gambling Task - hybrid; The participant performs the card selection task thanks to our homemade interface "LAB-Life".	Other: Survey; Participants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed; Device: Neurophysiological measure (EEG); Cerebral electric activity recorded with EEG
Experimental: Game of Dice Task - ecologic; The participant performs the dice-rolling task in its ecological version (with real dices).	Other: Survey; Participants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed
Active Comparator: Game of Dice Task - virtual; The participant performs the dice-rolling task in its virtual version (computer task)	Other: Survey; Participants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed; Device: Neurophysiological measure (EEG); Cerebral electric activity recorded with EEG
Experimental: Game of Dice Task - hybrid; The participant performs the dice-rolling task thanks to our homemade interface "LAB-Life".	Other: Survey; Participants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed; Device: Neurophysiological measure (EEG); Cerebral electric activity recorded with EEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Julie GIUSTINIANI, MD, CHU Besançon

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: brain activity; decision-making; ecological task
• Other Study ID Numbers: 2023/764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No