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Completed

NCT Number: NCT02444117

Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication in ASD

This study aims to identify clinical and biological markers which would allow to evaluate precisely the evolution of children with autism spectrum disorders throughout intervention.

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Key information

Conditions

Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

12 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital Tours

Tours, 37000, France

About this study

200 children with autism spectrum disorders (1-12 years old) will be included in a 2 years follow-up study. Both clinical and neurophysiological evaluations (electrophysiological and eye tracking) will be completed at different times of the follow-up. This integrative approach, combining clinical and biological markers, will allow the identification of different developmental trajectories and then a better individuation of treatment in autism spectrum disorders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • re-education of social communication

Exclusion criteria

  • multi-handicapped associated to ASD

Treatment and study plan

functional rehabilitation of social communication

Other

Primary outcomes

  1. Clinical changes between Baseline and Two years

    Time frame: 2 years

    Autism Diagnostic Observation Schedule (ADOS)

Secondary outcomes

  1. neurophysiological evaluations at baseline

    Time frame: baseline

    Event related potentials (ERPs) Visual ERPs : P100 evoked by pattern reversing checkerboard stimuli , N170 evoked by faces auditive ERPs: N1c and MMN evoked with an oddball pardaigm using simple tones, MMN evoked with an oddball pardaigm using emotional voices

  2. neurophysiological evaluations at 1 year

    Time frame: 1 year

    Event related potentials (ERPs) Visual ERPs : P100 evoked by pattern reversing checkerboard stimuli , N170 evoked by faces auditive ERPs: N1c and MMN evoked with an oddball pardaigm using simple tones, MMN evoked with an oddball pardaigm using emotional voices

  3. neurophysiological évaluations at 2 years

    Time frame: 2 years

    Event related potentials (ERPs) Visual ERPs : P100 evoked by pattern reversing checkerboard stimuli , N170 evoked by faces auditive ERPs: N1c and MMN evoked with an oddball pardaigm using simple tones, MMN evoked with an oddball pardaigm using emotional voices

  4. Social and cognitive evaluations at baseline

    Time frame: baseline

    Social and Cognitive Evaluation Battery (SCEB),

  5. Social and cognitive évaluations at 1 year

    Time frame: 1 year

    Social and Cognitive Evaluation Battery (SCEB),

  6. Social and cognitive évaluations at 2 years

    Time frame: 1 year

    Social and Cognitive Evaluation Battery (SCEB),

  7. Repetitive behaviors évaluations at baseline

    Time frame: baseline

    Repetitive and Restrictive Behavior Scale (RRBS)

  8. Repetitive behaviors évaluations at one year

    Time frame: 1 year

    Repetitive and Restrictive Behavior Scale (RRBS)

  9. Repetitive behaviors at two years

    Time frame: 2 years

    Repetitive and Restrictive Behavior Scale (RRBS)

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Autism Spectrum Disorders: Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
May 14, 2015
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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