Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02444117
Recruitment Status : Unknown
Verified May 2015 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : May 14, 2015
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:
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.

Condition or disease Intervention/treatment
Autistic Disorder Other: functional rehabilitation of social communication

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Autism Spectrum Disorders: Clinical and Neurophysiological Evolutions Through a Functional Rehabilitation of Social Communication
Study Start Date : February 2015
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clinical changes between Baseline and Two years [ Time Frame: 2 years ]
    Autism Diagnostic Observation Schedule (ADOS)


Secondary Outcome Measures :
  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)



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.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with autism spectrum disorders
Criteria

Inclusion Criteria:

  • re-education of social communication

Exclusion Criteria:

  • multi-handicapped associated to ASD

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): NCT02444117


Contacts
Layout table for location contacts
Contact: Joelle Malvy, MD, PhD 33 2 47 47 40 40 j.malvy@chu-tours.fr
Contact: Magali Batty, PhD 33 2 47 47 85 19 magali.batty@univ-tours.fr

Locations
Layout table for location information
France
University hospital Tours Recruiting
Tours, France, 37000
Contact: Joelle Malvy, MD, PhD    33 2 47474040    j.malvy@chu-tours.fr   
Contact: Magali Batty, PhD    33 2 4747 8519    magali.batty@univ-tours.fr   
Sponsors and Collaborators
University Hospital, Tours
Investigators
Layout table for investigator information
Principal Investigator: Joelle Malvy, MD, PhD University Hospital, Tours
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02444117    
Other Study ID Numbers: 2013-A012740-45
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by University Hospital, Tours:
neurophysiology
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders