Social Interactions: Ocular Explorations and Pupillometry in Autism (ISEOP)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 19, 2012 |
| Last Updated Date | July 19, 2012 |
| Start Date ICMJE | September 2012 |
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Total time spent on pictures [ Time Frame: two years ] [ Designated as safety issue: No ] Total time tracked during exploration of faces and human motion, compared to objects |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE |
Interest zones [ Time Frame: two years ] [ Designated as safety issue: No ] Time spent on interest zones such as eyes or mouth. |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Social Interactions: Ocular Explorations and Pupillometry in Autism |
| Official Title ICMJE | Social Interactions: Ocular Explorations and Pupillometry in Autism |
| Brief 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. 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 Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Autistic children from the University Hospital of Tours Healthy children from the normal population |
| Condition ICMJE | Autism Spectrum Disorders |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Not yet recruiting |
| Estimated Enrollment ICMJE | 150 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 3 Years to 12 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01647295 |
| Other Study ID Numbers ICMJE | C11-60, 2012-A00520-43 |
| Has Data Monitoring Committee | No |
| Responsible Party | Institut National de la Santé Et de la Recherche Médicale, France |
| Study Sponsor ICMJE | Institut National de la Santé Et de la Recherche Médicale, France |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Institut National de la Santé Et de la Recherche Médicale, France |
| Verification Date | July 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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