ASDIRM-ETNCT05194254
MRI-Eye Tracking Pairing, a Tool for Assessing Social Cognition in Children With ASD
A study testing MRI-ET in people with ASD and Functional Magnetic Resonance Imaging, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- ASD, Functional Magnetic Resonance Imaging, Eye Tracking
- What is being tested?
- MRI-ET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For the group of people with Autism Spectrum Disorders (experimental group):
- Age between 10 to 20 years old
- Diagnosis of ASD (CARS) ≥ 30 performed at inclusion
- 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
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- 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
- Diagnosis of ASD (CARS) <30 performed at inclusion
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Jean-Marc CONSTANS, PhD, +33322087511, constans.jean-marc@chu-amiens.fr
Olivier Balédent, PHD
About this study
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.
- Conditions
- ASD, Functional Magnetic Resonance Imaging, Eye Tracking, Social Cognition, Joint Attention
- Being tested
- MRI-ET
- Keywords
- ASD, Functional magnetic resonance imaging, Eye Tracking, social cognition, joint attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-ETOther
coupled fMRI and Eye Tracking tools
| Study group | Role | What they receive |
|---|---|---|
| ASD | Experimental | people with Autism Spectrum Disorders Receives: Other: MRI-ET |
| TD | Active comparator | Typical Development) group of people Receives: Other: MRI-ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start4 Jan 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194254
- Sponsor's protocol ID
- PI2021_843_0194
- Acronym
- IRM-ET
- Status last verified
- May 2025
- First submitted
- 4 Jan 2022
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Eye Tracking Pairing, a Tool for Assessing Social Cognition in Children With ASD
- ClinicalTrials.gov ID
- NCT05194254
- Acronym / sponsor ID
- IRM-ET / PI2021_843_0194
- Conditions
- ASD, Functional Magnetic Resonance Imaging, Eye Tracking, Social Cognition, Joint Attention
- Keywords
- ASD, Functional magnetic resonance imaging, Eye Tracking, social cognition, joint attention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD | Experimental | Other: MRI-ETpeople with Autism Spectrum Disorders |
| TD | Active comparator | Other: MRI-ETTypical Development) group of people |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Age between 10 to 20 years old
- Diagnosis of ASD (CARS) ≥ 30 performed at inclusion
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-ETcoupled fMRI and Eye Tracking tools | Other | ASD, TD |
Primary outcome
difference of mapping IRM-ET results between both patient groups
Time frame: one day
both patient groups are : the group of people with Autism Spectrum Disorders and Typical Development group of people
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-ET in people with ASD and Functional Magnetic Resonance Imaging, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc Constans, Pr (03 22 08 75 15, constans.jean-marc@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference of mapping IRM-ET results between both patient groups (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.