Viewing Study NCT06391684



Ignite Creation Date: 2024-05-06 @ 8:28 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06391684
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-04-30
First Post: 2024-02-08

Brief Title: Flexibility and the Predictive Brain in Autistic Males and Females
Sponsor: University Hospital Grenoble
Organization: University Hospital Grenoble

Study Overview

Official Title: Neurofunctional Specificities in Predictive Processing During High-Level Cognitive Flexibility Tasks in Autistic Males and Females
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FLEX-PREAU
Brief Summary: The goal of this study is to compare the neural correlates of predictive brain mechanisms during high-level social and non-social flexibility tasks between autistic and non-autistic males and females The aim is to better understand if autistic individuals differ from non-autistic individuals in their cognitive flexibility according to the social and predictable nature of the stimuli at a behavioral and neurofunctional level using the functional Magnetic Resonance Imaging fMRI As autistic females usually present a more subtle profile than autistic males the investigators will also explore if autistic males and females present neurofunctional differences
Detailed Description: Background

Autism spectrum conditions ASC may involve specificities in predictive brain mechanisms which guide perception together with sensory input These predictive mechanisms are at play in various aspects of life such as social interactions in which autistic individuals have difficulties They are also important for cognitive flexibility which involves changing tasks strategies or perspectives according to the situation recent research highlighted that autistic individuals faced difficulties in flexibly adjusting their predictions to unpredictable social contexts during a socio-emotional flexibility task social stimuli However they found no difference between autistic and non-autistic individuals during a cognitive flexibility task involving predictable changes of non-social stimuli This study aims to more precisely investigate which conditions lead to flexibility difficulties in autism ie the social context the unpredictability or both and to investigate the brain networks involved in autistic and non-autistic participants during high-level cognitive flexibility tasks involving social and non-social stimuli In addition autistic females often presenting better socio-communicational abilities than autistic males and a different profile from males in past research involving cognitive flexibility the investigators will explore if they present a different neurofunctional signature from males during these tasks

Procedure

The protocol begins with an imaging localization phase 5 minutes Subsequently functional MRI tasks T2 commence The protocol consists of two cognitive tasks performed within the MRI scanner each preceded by a training phase The acquisition of each participants anatomical sequence T1 5 minutes is conducted between the first two cognitive tasks to avoid compromising participant concentration Finally functional connectivity data are collected during a resting state sequence 10 minutes The study comprises a single visit

Cognitive Tasks

The protocol starts with an Emotional Shifting Task EST where participants evaluate the valence of emotion positive vs negative on an image while its truncated then the image appears not truncated and the participant must reevaluate its valence In some cases the valence has changed from positive to negative or from negative to positive and the participant must consider scene cues and demonstrate flexibility to reassess their judgment This task lasts approximately 11 minutes

In a second group of tasks the participant will perform adapted versions of the Task-Switching Task TST In the first task a letter and a number appear side by side surrounded by either a blue or yellow frame When the stimulus appears in a blue frame the participant must focus on the letter and press the left response button if its a consonant and the right response button if its a vowel When the stimulus appears in a yellow frame the participant must focus on the numbers and press the left response button when its odd and the right response button when its even In the first part the subject first practices only the letter task to assimilate the task Then similarly the subject practices only the number task Finally the subject performs the alternating task with 2 conditions of predictability predictable task change every three trials and not predictable random change This task lasts approximately 10 minutes The second task adds an emotional component to the TST task a face male or female associated with an emotion positive or negative is surrounded by either a blue or yellow frame When the stimulus appears in a blue frame the subject must focus on the gender and press the right response button if its a female and the left response button if its a male When the stimulus appears in a yellow frame the subject must focus on the facial emotion and press the right response button if its a positive facial emotion and the left response button if its a negative facial emotion In the first part the subject first practices only the gender task to assimilate the task Then similarly the subject practices only the emotional task Finally the subject performs the alternating task with the 2 conditions of predictability This task also lasts 10 minutes

Psychometric Assessment

The subject will also undergo a psychometric assessment including the Social Responsiveness Scale SRS Camouflaging Autistic Trait - questionnaire CAT-Q Weschler Adult Intelligence Scale 4th edition WAIS-4 Behavior Rating Inventory of Executive Function-Adult Version BRIEF-A Empathy Quotient EQ Autism Spectrum Quotient AQ and Autism Diagnostic Interview -revised ADI-R with the parent if possible

Hypotheses

Given the literature the investigators hypothesize a reduction in activation of certain areas in predictable conditions compared to unpredictable conditions indicating the presence of a prediction error Specifically in the socio-emotional flexibility task EST the investigators expect to observe this reduction particularly in the precuneus the temporal lobe the fusiform gyrus and the locus coeruleus In the cognitive flexibility task adapted TST the investigators will more specifically focus on the locus coeruleus The investigators also anticipate observing the involvement of a global functional network showing differences in activations between autistic and non-autistic individuals as well as a modulation of this reduction in activation prediction error between the two groups Finally the investigators hypothesize an intermediate profile in autistic females both at the behavioral and neurofunctional level situated between those of autistic males and non-autistic females

Data Analysis

Behavioral data will be analyzed in terms of accuracy rates and reaction times for both tasks fMRI data will undergo classical analysis General Linear Model - GLM This GLM analysis will allow a direct comparison of experimental conditions within the same group of participants and identify possible differences in activations between the groups

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2023-A01878-37 OTHER ID RCB None