Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 4:18 AM
Ignite Modification Date: 2025-12-25 @ 4:18 AM
NCT ID: NCT03793920
Brief Summary: Hypothesis: Individuals presenting with prenatal alcohol exposure (PEA) show emotional abilities deficits, and imbalance between the two systems involved in decision-making according to dual-process models, namely an under-activated reflective system (involved in deliberate behaviors) and an over-activated affective-automatic one (involved in impulsive behaviors). Primary objective: To explore performance (as a percentage of correct answers) in an emotional facial expression decoding task in PEA participants compared to controls without alcohol disorder.
Detailed Description: Each participant will undergo 2 visits : First visit : * Checking inclusion and non-inclusion criteria * Note of information and consent form * Record of concomitant treatments and anamnestic elements * Alcohol, Tobacco, and Toxic Consumption * Urinary Toxicity Test for Control Groups * Laterality test (Hecaen, 1984) * Brief visual and auditory acuity test * Standardized psychiatric interview (Mini International Neuropsychiatric Interview - MINI) Second visit = Experimental testing * State-Trait Anxiety Inventory, Beck Depression Inventory, Inventory of Interpersonal Problems, Toronto Alexithymia Scale (TAS-20). * Participant installation and testing: 6 behavioral tasks on a computer (also used to collect responses, except for task 2, see details below) : Task 1 (MAIN): Test for recognition of facial emotions Task 2: 'Reading the Mind in the Eyes Test' (Decoding of complex emotional states) Task 3: Emotional evaluation of natural scenes Task 4: Target detection (measure of attentional bias towards alcohol-related stimuli) Task 5: Go / No-Go evaluating the interactions between inhibition processes and auto-affective system Task 6: "N-back" evaluating the interactions between working memory and automatic-affective system
Study: NCT03793920
Study Brief:
Protocol Section: NCT03793920