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

Autistic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444117
• Other study ID #: 2013-A012740-45
• Status: Completed
• Start date: February 2015
• Est. completion date: February 2021

Study information

• Verified date: November 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 12 Years

Eligibility

Inclusion Criteria:

• re-education of social communication

Exclusion Criteria:

• multi-handicapped associated to ASD

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Other:
• functional rehabilitation of social communication

Locations

Country	Name	City	State
France	University hospital Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical changes between Baseline and Two years	Autism Diagnostic Observation Schedule (ADOS)	2 years
Secondary	neurophysiological evaluations at 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
Secondary	neurophysiological evaluations at 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
Secondary	neurophysiological évaluations at 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
Secondary	Social and cognitive evaluations at baseline	Social and Cognitive Evaluation Battery (SCEB),	baseline
Secondary	Social and cognitive évaluations at 1 year	Social and Cognitive Evaluation Battery (SCEB),	1 year
Secondary	Social and cognitive évaluations at 2 years	Social and Cognitive Evaluation Battery (SCEB),	1 year
Secondary	Repetitive behaviors évaluations at baseline	Repetitive and Restrictive Behavior Scale (RRBS)	baseline
Secondary	Repetitive behaviors évaluations at one year	Repetitive and Restrictive Behavior Scale (RRBS)	1 year
Secondary	Repetitive behaviors at two years	Repetitive and Restrictive Behavior Scale (RRBS)	2 years