Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation

NCT05596331 | Recruiting

• 2 other identifiers: DR220031/SIRCUS2022-A00870-43
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (6)

• Oculometric measurements 1: Tracking time

  Mean of tracking time (ms) during entire stimuli duration

  through study completion, an average of 1 year (first phase) and of 2 years (second phase)

• Oculometric measurements 2: Fixation time on the screen

  Mean of fixation time on the screen (ms) during entire stimuli duration

  through study completion, an average of 1 year (first phase) and of 2 years (second phase)

• Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration

  Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration

  through study completion, an average of 1 year (first phase) and of 2 years (second phase)

• Oculometric measurements 4: Fixation time on the mouth area of face stimuli

  Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration

  through study completion, an average of 1 year (first phase) and of 2 years (second phase)

• Pupillometric measurements

  Mean of pupil dilation variation(mm) in response to entire stimuli duration

  through study completion, an average of 1 year (first phase) and of 2 years (second phase)

• Discriminative power

  AUROC (Area Under the Receiver Operating Characteristics, in percent) analysis of combined oculometric and pupillometric measurements. Scale score : 0-100% (above 70% : good performance; above 80% : excellent performance; above 90% : outstanding performance)

  through study completion, an average of 1 year (first phase) and of 2 years (second phase)

Study Arms (5)

Group of adult subjects without ASD (Autism Spectrum Disorders)

OTHER

Age between 18 and 50 years

Other: eye-tracker

Group of children without ASD

OTHER

Age between 2 and 12 years

Other: eye-tracker

Group of children with ASD

OTHER

Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11

Other: eye-tracker

Group of children without NDD (NeuroDevelopmental Disorders)

OTHER

Age between 0 and 12 years

Other: eye-tracker

Group of children with NDD, or whose diagnosis is in progress

OTHER

Conformity to the diagnostic criteria of NDD

Other: eye-tracker

Interventions

eye-tracker OTHER

Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity

Group of adult subjects without ASD (Autism Spectrum Disorders); Group of children with ASD; Group of children with NDD, or whose diagnosis is in progress; Group of children without ASD; Group of children without NDD (NeuroDevelopmental Disorders)

Eligibility Criteria

• Age: 1 Day - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Phase 1:
• 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)

Sponsors & Collaborators

• University Hospital, Tours: lead
• UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.: collaborator
• Laboratory of Fundamental and Applied Computer Science of Tours, EA6300: collaborator
• National Research Agency, France: collaborator
• Ministry of Health, France: collaborator

Study Sites (1)

Service de Pédopsychiatrie-CHU-TOURS

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nadia Aguillon-Hernandez, MCU

  UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Aguillon-Hernandez, MCU

CONTACT

0247478840; nadia.aguillon@univ-tours.fr

Yosra DRIDI

CONTACT

+33247479792; Y.ABDERRAHMEN@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: October 27, 2022
• Study Start: January 3, 2023
• Primary Completion: January 3, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)