Flexibility and the Predictive Brain in Autistic Males and Females

NCT06391684 | Not Yet Recruiting DMC

• 2 other identifiers: 38RC23.03082023-A01878-37
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism Spectrum Disorder

Keywords

autism; flexibility; predictive coding; social cognition; sex differences

Outcome Measures

Primary Outcomes (1)

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

  fMRI BOLD signal

  during activation tasks

Secondary Outcomes (11)

• Functional connectivity specificity of autistic adults

  through study completion, an average of 1 year

• EST accuracy

  through study completion, an average of 1 year

• EST response time

  through study completion, an average of 1 year

• TST accuracy

  through study completion, an average of 1 year

• TST response time

  through study completion, an average of 1 year

Study Arms (2)

Autistic adults

Participants who have an autism diagnosis.

Behavioral: Social/non social; predictable vs unpredictable

Non autistic adults

Participants who do not have an autism diagnosis

Behavioral: Social/non social; predictable vs unpredictable

Interventions

Social/non social; predictable vs unpredictable BEHAVIORAL

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

Autistic adults; Non autistic adults

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Autistic with a diagnosis and non autistic adults.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire de Psychologie et NeuroCognition: collaborator

Related Publications (1)

• 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.

  PMID: 34957880 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: April 30, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share