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

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eye-tracker
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder

Eligibility Criteria

1 Day - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Other

    Other

    Other

    Other

    Other

    Arm Label

    Group of adult subjects without ASD (Autism Spectrum Disorders)

    Group of children without ASD

    Group of children with ASD

    Group of children without NDD (NeuroDevelopmental Disorders)

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

    Arm Description

    Age between 18 and 50 years

    Age between 2 and 12 years

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

    Age between 0 and 12 years

    Conformity to the diagnostic criteria of NDD

    Outcomes

    Primary Outcome Measures

    Oculometric measurements 1: Tracking time
    Mean of tracking time (ms) during entire stimuli duration
    Oculometric measurements 2: Fixation time on the screen
    Mean of fixation time on the screen (ms) during entire stimuli duration
    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
    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
    Pupillometric measurements
    Mean of pupil dilation variation(mm) in response to entire stimuli duration
    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% : excellente performance; above 90% : outstanding performance)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 8, 2022
    Last Updated
    November 9, 2022
    Sponsor
    University Hospital, Tours
    Collaborators
    UMR 1253, iBrain, Université de Tours, Inserm, Tours, France., Laboratory of Fundamental and Applied Computer Science of Tours, EA6300, National Research Agency, France, Ministry of Health, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05596331
    Brief Title
    Social Information Processing in Children: an ocUlo-pupillometric Tool for Standard Evaluation
    Acronym
    SIRCUS
    Official Title
    SIRCUS : Social Information pRocessing in Children:an ocUlo-pupillometric Tool for Standard Evaluation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2022 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Tours
    Collaborators
    UMR 1253, iBrain, Université de Tours, Inserm, Tours, France., Laboratory of Fundamental and Applied Computer Science of Tours, EA6300, National Research Agency, France, Ministry of Health, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    In a first phase (expected to last 12-16 months), after an experimental validation in typical adults, relevant oculometric and pupillometric indices will be identified in a typical population of children and in a clinically diagnosed population of ASD children. In a second phase of the protocol (expected to last 32-36 months), biomarkers identified in the first phase will be tested on a larger population including other neurodevelopmental disorders.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    460 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group of adult subjects without ASD (Autism Spectrum Disorders)
    Arm Type
    Other
    Arm Description
    Age between 18 and 50 years
    Arm Title
    Group of children without ASD
    Arm Type
    Other
    Arm Description
    Age between 2 and 12 years
    Arm Title
    Group of children with ASD
    Arm Type
    Other
    Arm Description
    Age between 2 and 12 years Conformity with the diagnostic criteria of ASD according to DSM-V, ICD-10 or ICD-11
    Arm Title
    Group of children without NDD (NeuroDevelopmental Disorders)
    Arm Type
    Other
    Arm Description
    Age between 0 and 12 years
    Arm Title
    Group of children with NDD, or whose diagnosis is in progress
    Arm Type
    Other
    Arm Description
    Conformity to the diagnostic criteria of NDD
    Intervention Type
    Other
    Intervention Name(s)
    eye-tracker
    Intervention Description
    Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
    Primary Outcome Measure Information:
    Title
    Oculometric measurements 1: Tracking time
    Description
    Mean of tracking time (ms) during entire stimuli duration
    Time Frame
    through study completion, an average of 1 year (first phase) and of 2 years (second phase)
    Title
    Oculometric measurements 2: Fixation time on the screen
    Description
    Mean of fixation time on the screen (ms) during entire stimuli duration
    Time Frame
    through study completion, an average of 1 year (first phase) and of 2 years (second phase)
    Title
    Oculometric measurements 3: Fixation time on the eye area during entire stimuli duration
    Description
    Mean of fixation time on the eye area of face stimuli (ms) during entire stimuli duration
    Time Frame
    through study completion, an average of 1 year (first phase) and of 2 years (second phase)
    Title
    Oculometric measurements 4: Fixation time on the mouth area of face stimuli
    Description
    Mean of fixation time on the mouth area of face stimuli (ms) during entire stimuli duration
    Time Frame
    through study completion, an average of 1 year (first phase) and of 2 years (second phase)
    Title
    Pupillometric measurements
    Description
    Mean of pupil dilation variation(mm) in response to entire stimuli duration
    Time Frame
    through study completion, an average of 1 year (first phase) and of 2 years (second phase)
    Title
    Discriminative power
    Description
    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% : excellente performance; above 90% : outstanding performance)
    Time Frame
    through study completion, an average of 1 year (first phase) and of 2 years (second phase)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nadia Aguillon-Hernandez, MCU
    Phone
    0247478840
    Email
    nadia.aguillon@univ-tours.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yosra DRIDI
    Phone
    +33247479792
    Email
    Y.ABDERRAHMEN@chu-tours.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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