- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02827279
Study of the Visual Perception During Emotional States on Subjects With an Intrusive Disorder of the Development (VisioTED)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Montpellier, France, 34295
- Montpellier University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients
Mesure of emotional induction by eye tracking on Patient with Pervasive Developmental Disorders (PDD)
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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
|
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Other: Healthy volunteers
Mesure of emotional induction by eye tracking on People without disorders
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratio corresponding to the relative change in visual orientation
Time Frame: 1 hour
|
mesured by eye tracking before and after each emotional induction
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent Henry, MD, CHU de Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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