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

November 2, 2022 updated by: University Hospital, Tours

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37000
        • university hospital Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with autism spectrum disorders

Description

Inclusion Criteria:

  • re-education of social communication

Exclusion Criteria:

  • multi-handicapped associated to ASD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical changes between Baseline and Two years
Time Frame: 2 years
Autism Diagnostic Observation Schedule (ADOS)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline
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
1 year
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
2 years
Social and cognitive evaluations at baseline
Time Frame: baseline
Social and Cognitive Evaluation Battery (SCEB),
baseline
Social and cognitive évaluations at 1 year
Time Frame: 1 year
Social and Cognitive Evaluation Battery (SCEB),
1 year
Social and cognitive évaluations at 2 years
Time Frame: 1 year
Social and Cognitive Evaluation Battery (SCEB),
1 year
Repetitive behaviors évaluations at baseline
Time Frame: baseline
Repetitive and Restrictive Behavior Scale (RRBS)
baseline
Repetitive behaviors évaluations at one year
Time Frame: 1 year
Repetitive and Restrictive Behavior Scale (RRBS)
1 year
Repetitive behaviors at two years
Time Frame: 2 years
Repetitive and Restrictive Behavior Scale (RRBS)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Joelle Malvy, MD, PhD, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A012740-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autistic Disorder

Clinical Trials on functional rehabilitation of social communication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe