Autism Spectrum DisordersISEOPNCT01647295
Social Interactions: Ocular Explorations and Pupillometry in Autism
An observational study of Autism Spectrum Disorders, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The primary objective of this work will first to characterize in typical childhood, visual exploratory behavior and pupillary response associated with salience of human social stimuli (faces and body movements), and then to evaluate these markers in children with autism. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2013to 18 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Autistic children from the University Hospital of Tours Healthy children from the normal population
Who may be able to join
- For autistic children, diagnosis of autism spectrum disorders according to DSM IV-TR and ADI / ADOS criteria ; normal or corrected vision; no nervous system disease
- For healthy children, normal schooling and normal or corrected vision
- For all, parental consents
Who cannot join
- psychotropic treatment
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this work will first to characterize in typical childhood, visual exploratory behavior and pupillary response associated with salience of human social stimuli (faces and body movements), and then to evaluate these markers in children with autism.
The second objective of this work will be to achieve in a population of children with autism a longitudinal evaluation of these markers during development and therapeutics.
Read the detailed description
Patients with autism have significant social difficulties and communication alterations. It has been shown in these patients difficulties to understand some clues indispensable to social relations, for example, faces and their emotions and motion of human bodies. The faces and human movements are an important source of information helping to interact with others. Understanding the intentions of the others through facial expressions and gestures can help them to adapt their behavior and their interactions. While in healthy subjects, faces and human movements receive special attention, autistic patients seem to pay less attention to this kind of social stimuli. It has already been shown that children and healthy adults spend more time looking at faces and human movements (relative to objects), whereas the opposite behavior is observed in patients with autism. Studying gaze behavior seems to be essential for progress in the understanding of autism pathology. Eye-tracking systems allow to measure precisely what a subject looks on a picture. Moreover, eye-tracking systems permit the measurement of the pupil size which variations are correlated with cognitive processes. The objective of this study is to analyze the ocular behavior (ocular scan path and pupil diameter) of young patients with autism when viewing faces and human movements and to compare these measurements with those of chronologically age-matched healthy children. This work will identify attentional problems concerning exploration of human faces and movements that can be related to their social difficulties. These disorders should be manifested by an atypical ocular scan path and by changes in pupil variation in response to face and human motion. Then to follow the evolution of these indices will allow to evaluate the effect of therapies. These results will highlight new data essential to understanding disorders of social relations and to better adapt rehabilitative strategies.
- Conditions
- Autism Spectrum Disorders
- Keywords
- visual exploration, pupil size, social interactions, faces, human motion
- Medical subject headings
- Autism Spectrum Disorder, DiGeorge Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time spent on pictures
Total time tracked during exploration of faces and human motion, compared to objects
Measured: two years
Secondary outcomes (1)
Interest zones
Time spent on interest zones such as eyes or mouth.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study start25 Feb 2013
- Primary completionJun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647295
- Sponsor's protocol ID
- C11-60
- Other IDs
- 2012-A00520-43
- Acronym
- ISEOP
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2012
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Aguillon-Hernandez N, Mofid Y, Latinus M, Roche L, Bufo MR, Lemaire M, Malvy J, Martineau J, Wardak C, Bonnet-Brilhault F. The pupil: a window on social automatic processing in autism spectrum disorder children. J Child Psychol Psychiatry. 2020 Jul;61(7):768-778. doi: 10.1111/jcpp.13170. Epub 2019 Dec 11.
PubMed 31823380
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Interactions: Ocular Explorations and Pupillometry in Autism
- ClinicalTrials.gov ID
- NCT01647295
- Acronym / sponsor ID
- ISEOP / C11-60
- Conditions
- Autism Spectrum Disorders
- Keywords
- visual exploration, pupil size, social interactions, faces, human motion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 25 Feb 2013 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 23 Jul 2012 (estimated)
- 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.
The primary objective of this work will first to characterize in typical childhood, visual exploratory behavior and pupillary response associated with salience of human social stimuli (faces and body movements), and then to evaluate these markers in children with autism.
The second objective of this work will be to achieve in a population of children with autism a longitudinal evaluation of these markers during development and therapeutics.
Detailed description
Patients with autism have significant social difficulties and communication alterations. It has been shown in these patients difficulties to understand some clues indispensable to social relations, for example, faces and their emotions and motion of human bodies. The faces and human movements are an important source of information helping to interact with others. Understanding the intentions of the others through facial expressions and gestures can help them to adapt their behavior and their interactions. While in healthy subjects, faces and human movements receive special attention, autistic patients seem to pay less attention to this kind of social stimuli. It has already been shown that children and healthy adults spend more time looking at faces and human movements (relative to objects), whereas the opposite behavior is observed in patients with autism. Studying gaze behavior seems to be essential for progress in the understanding of autism pathology. Eye-tracking systems allow to measure precisely what a subject looks on a picture. Moreover, eye-tracking systems permit the measurement of the pupil size which variations are correlated with cognitive processes. The objective of this study is to analyze the ocular behavior (ocular scan path and pupil diameter) of young patients with autism when viewing faces and human movements and to compare these measurements with those of chronologically age-matched healthy children. This work will identify attentional problems concerning exploration of human faces and movements that can be related to their social difficulties. These disorders should be manifested by an atypical ocular scan path and by changes in pupil variation in response to face and human motion. Then to follow the evolution of these indices will allow to evaluate the effect of therapies. These results will highlight new data essential to understanding disorders of social relations and to better adapt rehabilitative strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Autistic children from the University Hospital of Tours Healthy children from the normal population
Key inclusion criteria (3 listed)
- For autistic children, diagnosis of autism spectrum disorders according to DSM IV-TR and ADI / ADOS criteria ; normal or corrected vision; no nervous system disease
- For healthy children, normal schooling and normal or corrected vision
- For all, parental consents
Key exclusion criteria (1 listed)
- psychotropic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total time spent on pictures
Time frame: two years
Total time tracked during exploration of faces and human motion, compared to objects
1 secondary outcome
Interest zones
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 31823380Aguillon-Hernandez N, Mofid Y, Latinus M, Roche L, Bufo MR, Lemaire M, Malvy J, Martineau J, Wardak C, Bonnet-Brilhault F. The pupil: a window on social automatic processing in autism spectrum disorder children. J Child Psychol Psychiatry. 2020 Jul;61(7):768-778. doi: 10.1111/jcpp.13170. Epub 2019 Dec 11.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders, run by Institut National de la Santé Et de la Recherche Médicale, France 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 4 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time spent on pictures (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647295, which also lists 1 linked publication.
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 4 Dec 2025.