NCT02827279

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2017

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

4.1 years

First QC Date

July 6, 2016

Last Update Submit

December 27, 2021

Conditions

Keywords

Autism Spectrum DisorderEmotion

Outcome Measures

Primary Outcomes (1)

  • Ratio corresponding to the relative change in visual orientation

    mesured by eye tracking before and after each emotional induction

    1 hour

Study Arms (2)

Patients

OTHER

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

Other: emotional induction

Healthy volunteers

OTHER

Mesure of emotional induction by eye tracking on People without disorders

Other: emotional induction

Interventions

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 volunteersPatients

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Vincent Henry, MD

    CHU de Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 11, 2016

Study Start

March 4, 2013

Primary Completion

April 3, 2017

Study Completion

April 3, 2017

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations