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

December 4, 2023 updated by: University Hospital, Tours

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
460

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Tours, France, 37044
        • Recruiting
        • Service de Pédopsychiatrie-CHU-TOURS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group of adult subjects without ASD (Autism Spectrum Disorders)
Age between 18 and 50 years
Other: eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Other: Group of children without ASD
Age between 2 and 12 years
Other: eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Other: 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
Other: eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Other: Group of children without NDD (NeuroDevelopmental Disorders)
Age between 0 and 12 years
Other: eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity
Other: Group of children with NDD, or whose diagnosis is in progress
Conformity to the diagnostic criteria of NDD
Other: eye-tracker
Eye-tracker recordings of eye movements, gaze direction and pupillary reactivity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oculometric measurements 1: Tracking time
Time Frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
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
Time Frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
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
Time Frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
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
Time Frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
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
Time Frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
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
Time Frame: through study completion, an average of 1 year (first phase) and of 2 years (second phase)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France
National Research Agency, France
UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.
Laboratory of Fundamental and Applied Computer Science of Tours, EA6300

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nadia Aguillon-Hernandez, MCU, UMR 1253, iBrain, Université de Tours, Inserm, Tours, France.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DR220031/SIRCUS
  • 2022-A00870-43 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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