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NCT06337500 Clinical Trial

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

Healthy Volunteers Clinical Trial

— LABLife  

Official title:
Validation of a Making Decision Hybrid (Ecologic and Virtual) Task

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06337500
Other study ID # 2023/764
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date June 1, 2025

Study information
Verified date March 2024
Source Centre Hospitalier Universitaire de Besancon
Contact Karine CHARRIERE, PhD
Phone +333 81218999
Email kcharriere@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 180
Est. completion date June 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Neurophysiological measure (EEG)
Cerebral electric activity recorded with EEG
Other:
• Survey
Participants complete a survey to evaluate their exposure to screens and their assessment of the laboratory task performed

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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