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Social Interactions: Ocular Explorations and Pupillometry in Autism (ISEOP)

This study is currently recruiting participants.
Verified February 2016 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT01647295
First Posted: July 23, 2012
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
  Purpose

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.


Condition
Autism Spectrum Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Social Interactions: Ocular Explorations and Pupillometry in Autism

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Total time spent on pictures [ Time Frame: two years ]
    Total time tracked during exploration of faces and human motion, compared to objects


Secondary Outcome Measures:
  • Interest zones [ Time Frame: two years ]
    Time spent on interest zones such as eyes or mouth.


Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
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.
  Eligibility

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Autistic children from the University Hospital of Tours Healthy children from the normal population
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • psychotropic treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647295


Contacts
Contact: Frederique Bonnet-Brilhault, PU-PH 0247478412 f.bonnet-brilhault@chu-tours.fr

Locations
France
CHRU Bretonneau Recruiting
Tours, France, 37044
Principal Investigator: Frederique Bonnet-Brilhault, PU-PH         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01647295     History of Changes
Other Study ID Numbers: C11-60
2012-A00520-43 ( Registry Identifier: IDRCB )
First Submitted: July 19, 2012
First Posted: July 23, 2012
Last Update Posted: February 25, 2016
Last Verified: February 2016

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
visual exploration
pupil size
social interactions
faces
human motion

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders