NCT05194254

Brief Summary

Most studies use static visual percepts that are less representative of joint attention versus an ecological environment. This has the consequence of decreasing the perception of an interaction with a social partner, which is an essential step in achieving joint attention. The originality of this study is to improve the design of visual percepts (in the form of video) in order to mimic an ecological environment as much as possible by using MRI-ET coupling. The second originality of this study is the longitudinal exploration of the neurodevelopment of social cognition in autistic children. Studies by the Redcay and Oberwelland teams observe different activations at different ages. The hypothesis is that the perception of joint attention varies over time in people with ASD. To date, there are no studies to determine the influence of childhood neurodevelopment in autistic people on the perception of joint attention. It would be unprecedented to use the MRI-ET pairing as a tool for assessing social cognition as a function of the development of children with ASD.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

January 4, 2022

Last Update Submit

May 22, 2025

Conditions

Keywords

ASDFunctional magnetic resonance imagingEye Trackingsocial cognitionjoint attention

Outcome Measures

Primary Outcomes (1)

  • difference of mapping IRM-ET results between both patient groups

    both patient groups are : the group of people with Autism Spectrum Disorders and Typical Development group of people

    one day

Study Arms (2)

ASD

EXPERIMENTAL

people with Autism Spectrum Disorders

Other: MRI-ET

TD

ACTIVE COMPARATOR

Typical Development) group of people

Other: MRI-ET

Interventions

MRI-ETOTHER

coupled fMRI and Eye Tracking tools

ASDTD

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For the group of people with Autism Spectrum Disorders (experimental group):
  • Age between 10 to 20 years old
  • IQ test evaluation (regardless of the result) performed by a trained psychologist
  • Obtaining informed oral and written consent after appropriate information
  • Obtaining informed oral and written consent from the legal guardian after information
  • Be affiliated with social security
  • No contraindication to magnetic resonance imaging
  • For the TD (Typical Development) group of people (control group):
  • Age between 10 to 20 years old
  • IQ test evaluation (regardless of the result) performed by a trained psychologist
  • Obtaining informed oral and written consent after appropriate information
  • Obtaining informed oral and written consent from the legal guardian after information
  • Be affiliated with social security
  • No contraindication to magnetic resonance imaging

You may not qualify if:

  • For all groups:
  • Age outside the range 10 to 20 years
  • Person with a contraindication to MRI (including claustrophobia, pace maker, neurosurgical clips, vascular clips, heart valves, ventriculoperitoneal valves, cochlear implant, neurostimulator, intraocular metal shards, joint prosthesis, etc.)
  • Person suffering from major obesity (\> 140 kg) not allowing him to enter the tunnel of the MRI machine (diameter \<70cm)
  • Pregnant or breastfeeding woman
  • Person under guardianship or guardianship or deprived of liberty by a judicial or administrative decision
  • For TD people (control group):
  • Person with psychiatric disorders such as attention disorder with or without hyperactivity, depression, bipolar disorder and schizophrenia.
  • Person with a neurological history such as epilepsy and / or neurovascular accident.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

Central Study Contacts

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

January 4, 2022

First Posted

January 18, 2022

Study Start

January 4, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations