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Study of the Visual Perception During Emotional States on Subjects With an Intrusive Disorder of the Development (VisioTED)

Primary Purpose

Autism Spectrum Disorder

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
emotional induction
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Emotion

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of Asperger syndrome or infantile autism (F84.0 et F84.5, classification CIM10, 1992).
  • Total score in the algorithm of ADI and ADOS > at the threshold required for the diagnosis of disorders(confusions) of the autistic spectre
  • Intelligence quotient verbal (IQ) upper to 70 in the various tests psychométriques
  • Chronological age from 8 to 12 years
  • Written consent signed by the parents and the child
  • Affiliation or recipient with the mode of social security.

Exclusion Criteria:

  • Consent refusal of the child or parents
  • Presence of neurovisual disorder

Sites / Locations

  • Montpellier University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients

Healthy volunteers

Arm Description

Mesure of emotional induction by eye tracking on Patient with Pervasive Developmental Disorders (PDD)

Mesure of emotional induction by eye tracking on People without disorders

Outcomes

Primary Outcome Measures

Ratio corresponding to the relative change in visual orientation
mesured by eye tracking before and after each emotional induction

Secondary Outcome Measures

Full Information

First Posted
July 6, 2016
Last Updated
December 27, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02827279
Brief Title
Study of the Visual Perception During Emotional States on Subjects With an Intrusive Disorder of the Development
Acronym
VisioTED
Official Title
Study of the Strategies of Visual Perception of Social Scenes During Emotional States Induced to Subjects With an Intrusive Disorder of the Development: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
end of inclusion period
Study Start Date
March 4, 2013 (Actual)
Primary Completion Date
April 3, 2017 (Actual)
Study Completion Date
April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders, affecting nearly 1% of the general population. The disorder of social interaction has often been described as resulting from poor emotion recognition, or a bad perception of biological motion. However, the results of studies on these issues are very divergent. The PDD also been described as a disorder of emotion regulation, but few studies address the emotional feelings of individuals with ASD and their neuropsychological implications. The main objective is to study the effect of induced emotion in the children with ASD on his visual exploration strategies. This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy terms of the look in a group of children with ASD, in a context of emotional induction (joy, fear, sadness or anger) using of sound stimuli.
Detailed Description
Context: The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders, affecting nearly 1% of the general population. The disorder of social interaction has often been described as resulting from poor emotion recognition, or a bad perception of biological motion. However, the results of studies on these issues are very divergent. The PDD also been described as a disorder of emotion regulation, but few studies address the emotional feelings of individuals with ASD and their neuropsychological implications. Many studies analyzing the effect of emotions induced - or felt - in healthy subjects. The effect of emotion on cognitive or attentional process is often called "emotional effect of interference." As has already been demonstrated, an emotion (eg induced by music or film) results in a change in visual perception of the environment strategies. These non-conscious mechanisms promote interactive synchrony with the surrounding world, especially during social interactions. We then assumed that the alteration of these perceptual-emotional regulation processes in PDD contribute to disorders of social interactions. In the absence of sufficient data in the literature, we wish to establish an exploratory study using the Eye-tracking, to objectify the links between emotional and perceptual processing in PDD. Objectives: The main objective is to study the effect of induced emotion in the children with ASD on his visual exploration strategies. We assume that the direction of gaze to photographs of different emotional valences in individuals with ASD is not changed by the emotional state in which they are located. We will compare a population of children with PDD in a control population matched for age, sex. Our secondary goal is to study the link between 1) the socio adaptive level (measured by the Vineland 2) the intensity of autistic symptoms (score ADI) and gaze orientation towards social subjects with visual stimuli. Methods: This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy terms of the look in a group of children with ASD, in a context of emotional induction (joy, fear, sadness or anger) using of sound stimuli. Conclusion: This study would better characterize the emotional processing in ASD and generate hypotheses that could be tested in other neurophysiological studies. Moreover, it can contribute to the development of new supported techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, Emotion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Other
Arm Description
Mesure of emotional induction by eye tracking on Patient with Pervasive Developmental Disorders (PDD)
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Mesure of emotional induction by eye tracking on People without disorders
Intervention Type
Other
Intervention Name(s)
emotional induction
Intervention Description
The eye-tracking mesure the reaction at emotional induction using of sound stimuli in a group of children with or without ASD, in a context of
Primary Outcome Measure Information:
Title
Ratio corresponding to the relative change in visual orientation
Description
mesured by eye tracking before and after each emotional induction
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of Asperger syndrome or infantile autism (F84.0 et F84.5, classification CIM10, 1992). Total score in the algorithm of ADI and ADOS > at the threshold required for the diagnosis of disorders(confusions) of the autistic spectre Intelligence quotient verbal (IQ) upper to 70 in the various tests psychométriques Chronological age from 8 to 12 years Written consent signed by the parents and the child Affiliation or recipient with the mode of social security. Exclusion Criteria: Consent refusal of the child or parents Presence of neurovisual disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Henry, MD
Organizational Affiliation
CHU de Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of the Visual Perception During Emotional States on Subjects With an Intrusive Disorder of the Development

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