NCT06337500

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
0mo left

Started Feb 2024

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Feb 2024Jun 2026

Study Start

First participant enrolled

February 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

March 15, 2024

Last Update Submit

July 16, 2025

Conditions

Healthy VolunteersBehavior and Behavior Mechanisms

Keywords

decision-makingecological taskbrain activity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

Iowa Gambling Task - ecologic

EXPERIMENTAL

The participant performs the card selection task in its ecological version (with real cards).

Other: Survey

Iowa Gambling Task - virtual

ACTIVE COMPARATOR

The participant performs the card selection task in its virtual version (computer task).

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".

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).

Other: Survey

Game of Dice Task - virtual

ACTIVE COMPARATOR

The participant performs the dice-rolling task in its virtual version (computer task)

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".

Device: Neurophysiological measure (EEG)Other: Survey

Interventions

Neurophysiological measure (EEG)DEVICE

Cerebral electric activity recorded with EEG

Game of Dice Task - hybridGame of Dice Task - virtualIowa Gambling Task - hybridIowa Gambling Task - virtual
SurveyOTHER

Participants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed

Game of Dice Task - ecologicGame of Dice Task - hybridGame of Dice Task - virtualIowa Gambling Task - ecologicIowa Gambling Task - hybridIowa Gambling Task - virtual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, Not in US/Canada, France

RECRUITING

MeSH Terms

Conditions

Behavior

Interventions

ElectroencephalographySurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Julie GIUSTINIANI, MD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine CHARRIERE, PhD

CONTACT

+333 81218999kcharriere@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 29, 2024

Study Start

February 1, 2024

Primary Completion

February 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)