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Autism Spectrum DisorderFLEX-PREAUNCT06391684

Flexibility and the Predictive Brain in Autistic Males and Females

An observational study of Autism Spectrum Disorder, run by University Hospital, Grenoble at 1 site in France.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Social/non social; predictable vs unpredictable
How many people
40 participants
Where
1 siteFrance
Study dates
21 Feb 2025to 20 Apr 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Autistic with a diagnosis and non autistic adults.

Who may be able to join

  • For non autistic individuals
  • Affiliation with social security scheme.
  • Registration in the national database of individuals willing to participate in research involving human subjects.
  • Absence of contraindications for MRI.
  • Signed informed consent before any study-related procedure.
  • Visual acuity allowing normal perception of stimuli or corrected vision.
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  • Autism Quotient (AQ) (Baron-Cohen et al., 2001) < 32.
  • For autistic individuals:
  • Affiliation with social security scheme.
  • Absence of contraindications for MRI.
  • Signed informed consent before any study-related procedure.
  • Visual acuity allowing normal perception of stimuli or corrected vision.
  • Diagnosis of autism established by a competent professional based on DSM/ICD criteria.

Who cannot join

  • Any subject with a vascular stent implanted less than 6 weeks before the examination.
  • Any subject with implanted biomedical material deemed "unsafe" or "not safe" in the list: http://www.mrisafety.com/TheList_search.asp.
  • Any acquisition procedure not meeting the conditions required for "conditional" use in subjects with implanted biomedical material classified as "conditional" in the list: http://www.mrisafety.com/TheList_search.asp.
  • Any subject with biomedical material such as a cardiac, neuronal, or sensory stimulator (cochlear implant due to the risk of demagnetization, heating, electrode, and artifacts) or a ventricular shunt valve without medical and paramedical supervision trained in MRI performance in these subjects.
  • Intraocular or intracranial ferromagnetic foreign body near nerve structures (risk of displacement and complications such as ocular or cerebral lesions).
  • Claustrophobia - Psychiatric or neurological conditions other than those specified.
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  • Existence of a severe general health condition incompatible with the study: cardiac, respiratory, hematological, renal, hepatic, or cancerous.
  • Alcohol ingestion before the examination.
  • Persons covered by articles L1121-5 to L1121-8 of the Public Health Code (pregnant or breastfeeding women, minors or adults under legal protection, individuals under administrative or judicial surveillance).
  • Visual impairments.
  • Intellectual disability.
  • Inability to understand research instructions or provide informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • CHU Grenoble Alpes_DRCI_Pavillon Dauphiné_CS

    Grenoble, 38043

    Monica BACIU, +33 476 825 880, mbaciu@chu-grenoble.fr

    Adeline LACROIX, +33 (0)6 63 87 54 15, adeline.lacroix@univ-grenoble-alpes.fr

    Recruiting

Other trials in France

About this study

Official title: Neurofunctional Specificities in Predictive Processing During High-Level Cognitive Flexibility Tasks in Autistic Males and Females

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.

Read the 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 (i.e., 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 participant's 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 it's 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 it's a consonant and the right response button if it's a vowel. When the stimulus appears in a yellow frame, the participant must focus on the numbers and press the left response button when it's odd and the right response button when it's 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 it's a female and the left response button if it's 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 it's a positive facial emotion and the left response button if it's 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.

Being tested
Social/non social; predictable vs unpredictable
Keywords
autism, flexibility, predictive coding, social cognition, sex differences
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social/non social; predictable vs unpredictableBehavioural

    Task 1: social predictable vs social unpredictable ; Task2 a. social \& b. non social, predictable/unpredictable (for both)

Study groups in NCT06391684
Study groupRoleWhat they receive
Autistic adultsParticipants who have an autism diagnosis.
Receives: Behavioral: Social/non social; predictable vs unpredictable
Non autistic adultsParticipants who do not have an autism diagnosis
Receives: Behavioral: Social/non social; predictable vs unpredictable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurofunctional activity specificity of autistic adults in predictive processes during cognitive flexibility tasks

    fMRI BOLD signal

    Measured: during activation tasks

Secondary outcomes (11)
  1. Functional connectivity specificity of autistic adults

    BOLD-fMRI signal during resting state (BOLD-RS)

    Measured: through study completion, an average of 1 year

  2. EST accuracy

    the emotional shifting task (EST), is one of the task that will be performed in the fMRI. During this task participants evaluate the valence of emotion (positive vs. negative) on an image while it's 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.

    We will collect the accuracy of this task

    Measured: through study completion, an average of 1 year

  3. EST response time

    We will collect the response time in this task (described above)

    Measured: through study completion, an average of 1 year

  4. TST accuracy

    The Task-Switching Task (TST) is described in the study description. We will collect the accuracy of this task

    Measured: through study completion, an average of 1 year

  5. TST response time

    We will collect the response time in this task (described above)

    Measured: through study completion, an average of 1 year

  6. SRS

    The social responssivness scale is a scale giving a score between 0 and 195, that help to identify social difficulties in autism. Higher values indicate greater expression of the ASD-related phenotype. The self reported-version will be used.

    Measured: through study completion, an average of 1 year

  7. AQ

    The Autism spectrum quotient is a self-administrated questionnaire, with scores ranging from 0 to 50, that helps to identify autistic traits. Higher values indicate greater expression of the ASD-related phenotype

    Measured: through study completion, an average of 1 year

  8. EQ

    The empathy quotient is a self-administrated questionnaire, with scores ranging from 0 to 80. Higher values indicate high ability to understand how other people feel

    Measured: through study completion, an average of 1 year

  9. CAT-Q

    The Camouflaging Autistic Trait Questionnaire (CAT-Q) is a self-administered questionnaire, with scores ranging from 25 to 75. Higher values indicate greater camouflaging, i.e., greater ability to mask autistic symptoms in social contexts.

    Measured: through study completion, an average of 1 year

  10. BRIEF-A

    The Behavior Rating Inventory of Executive Function-Adult Version ( BRIEF-A) is a self-administrated questionnaire measuring executive dysfunctions. The global raw score can range from 70 to 210. Higher scores indicate greater executive dysfunctions

    Measured: through study completion, an average of 1 year

  11. WAIS-IV

    The Weschler Adult Intelligence Scale 4th edition (WAIS-IV) measure IQ. Higher scores indicate a higher Intelligence Quotient - IQ)

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start21 Feb 2025
  3. Primary completion20 Apr 2029 (estimated)
  4. Study completion20 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06391684
Sponsor's protocol ID
38RC23.0308
Other IDs
2023-A01878-37
Acronym
FLEX-PREAU
Status last verified
Sep 2026
First submitted
8 Feb 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lacroix A, Dutheil F, Logemann A, Cserjesi R, Peyrin C, Biro B, Gomot M, Mermillod M. Flexibility in autism during unpredictable shifts of socio-emotional stimuli: Investigation of group and sex differences. Autism. 2022 Oct;26(7):1681-1697. doi: 10.1177/13623613211062776. Epub 2021 Dec 27.

    PubMed 34957880

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorder, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurofunctional activity specificity of autistic adults in predictive processes during cognitive flexibility tasks (time frame: during activation tasks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06391684, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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