NCT05596331 Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation
| NCT ID | NCT05596331 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Tours |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2023-01-03 |
| Primary Completion | 2026-01-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 460 participants in total. It began in 2023-01-03 with a primary completion date of 2026-01-03.
⚠ 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 observational study is to identify behavioral and physiological markers of social alterations in Autism Spectrum Disorders compared to Typically Developping peers. This single-centre study plan to use eye tracking to evaluate social disorders in Autism Spectrum Disorders (ASD). The investigators will estimate oculometric and pupillometric indices as potential ASD biomarkers. The study will last 4 years and will be organized in two phases.
Eligibility Criteria
Inclusion Criteria: Phase 1 All groups have these 2 criteria in common: Free, informed and signed consent of both parents Enrolment in the social security system The other criteria per group are as follows: Group of adult subjects without ASD : Age between 18 and 50 years Group of children without ASD * Age between 2 and 12 years * Group of children with ASD Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11 Phase 2 * Group of children without TND : Age between 0 and 12 years * Group of children with TND, or whose diagnosis is in progress (via PCO referral) : Age between 0 and 12 years Conformity to the diagnostic criteria of TND Exclusion Criteria: Phase 1: All groups have the 2 common exclusion criteria Known uncorrected visual pathologies Known personal neurological pathologies And they have these criteria per group: * Group of adult subjects without ASD: Subject under guardianship or trusteeship Diagnosis of ASD Group of children without ASD : Diagnosis of ASD * Group of children with ASD ICD-10 diagnosis of PDD (Rett syndrome and Hayler syndrome) Phase 2 * Group of children without ASD : Diagnosis of ASD (confirmed or ongoing)
Contact & Investigator
Nadia Aguillon-Hernandez, MCU
PRINCIPAL INVESTIGATOR
UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.
Frequently Asked Questions
Who can join the NCT05596331 clinical trial?
This trial is open to participants of all sexes, aged 1 Day 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 NCT05596331 currently recruiting?
Yes, NCT05596331 is actively recruiting participants. Contact the research team at nadia.aguillon@univ-tours.fr for enrollment information.
Where is the NCT05596331 trial being conducted?
This trial is being conducted at Tours, France.
Who is sponsoring the NCT05596331 clinical trial?
NCT05596331 is sponsored by University Hospital, Tours. The principal investigator is Nadia Aguillon-Hernandez, MCU at UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.. The trial plans to enroll 460 participants.