We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified March 2016 by University Hospital, Montpellier
Sponsor:
ClinicalTrials.gov Identifier:
NCT02827279
First Posted: July 11, 2016
Last Update Posted: March 31, 2017
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):
University Hospital, Montpellier
  Purpose

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.


Condition Intervention
Autism Spectrum Disorder Other: emotional induction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Ratio corresponding to the relative change in visual orientation [ Time Frame: 1 hour ]
    mesured by eye tracking before and after each emotional induction


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients
Mesure of emotional induction by eye tracking on Patient with Pervasive Developmental Disorders (PDD)
Other: emotional induction
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
Healthy volunteers
Mesure of emotional induction by eye tracking on People without disorders
Other: emotional induction
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  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): NCT02827279


Contacts
Contact: Vincent Henry, MD 0033467339864 v-henry@chu-montpellier.fr

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34295
Contact: Vincent Henry, MD    0033467339864    v-henry@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Vincent Henry, MD CHU de Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02827279     History of Changes
Other Study ID Numbers: 8991
First Submitted: July 6, 2016
First Posted: July 11, 2016
Last Update Posted: March 31, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Montpellier:
Autism Spectrum Disorder
Emotion

Additional relevant MeSH terms:
Disease
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders