NCT06391684 Flexibility and the Predictive Brain in Autistic Males and Females
| NCT ID | NCT06391684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Autism Spectrum Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2029-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-02-21 with a primary completion date of 2029-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT06391684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06391684 currently recruiting?
Yes, NCT06391684 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Grenoble to inquire about joining.
Where is the NCT06391684 trial being conducted?
This trial is being conducted at Grenoble, France.
Who is sponsoring the NCT06391684 clinical trial?
NCT06391684 is sponsored by University Hospital, Grenoble. The trial plans to enroll 40 participants.