NCT03182400

Brief Summary

It is now widely accepted that autism is linked to a developmental disorder and cerebral function. Our research team (UMR U930 INSERM, François-Rabelais University of Tours, whom Pr F Bonnet-Brilhault is responsible for team "Autism") hypothesizes that atypical sensory information processing, especially auditory and / or visual information, could underly the symptoms observed in autism. A better knowledge of the typical development of the sensory and cognitive processes must therefore make it possible in the long term to identify the abnormalities linked to the autism spectrum disorders (ASD). Studies in healthy subjects are therefore necessary in order to identify neurophysiological indices of cerebral functioning and to study their evolution during normal development, making it possible in the future to compare with populations of subjects with ASD. The investigators intend to study the development of all the cognitive processes involved in the processing of sensory and, in particular, auditory and visual information in humans: from low-level perception processes to higher-level cognitive processes (attention, emotion, language, prediction, ...). For this the investigators will use non-invasive neurophysiological explorations (EEG, eye tracking) as well as neuropsychological explorations (Questionnaires or spontaneous language recording). A better understanding of the pathophysiological mechanisms underlying the symptoms observed in autism could ultimately lead to the development of new specific therapeutic strategies, particularly in the field of exchange and development therapy or cognitive remediation .

Trial Health

77
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jun 2017Jun 2027

First Submitted

Initial submission to the registry

May 23, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

June 14, 2017

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

10 years

First QC Date

May 23, 2017

Last Update Submit

September 8, 2022

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • ERP amplitude (µV)

    analysis of ERP amplitude evoked during EEG recording

    1 hour

Secondary Outcomes (2)

  • Reaction times (ms)

    1 hour

  • pupil size (mm)

    1 hour

Study Arms (1)

Healthy volunteer

EXPERIMENTAL

Neurophysiological assessment Neuropsychological assessment

Behavioral: Neurophysiological assessmentBehavioral: Neuropsychological assessment

Interventions

Neurophysiological assessmentBEHAVIORAL

Assessment of cerebral electrical activity Assessment of ocular exploration Neurovegetative assessments

Healthy volunteer
Neuropsychological assessmentBEHAVIORAL

sub-tests, scales, surveys, reaction time measurement

Healthy volunteer

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Between 1 and 60 years-old
  • Able to understand and apply instructions for a task
  • Information of subject or legal representant
  • Informed written consent of subject or legal representant
  • Affiliation to the social security system

You may not qualify if:

  • Abnormal corrected vision
  • Abnormal audition
  • Known personal neurological pathology
  • Known personal psychiatric problems
  • Identified difficulties for walking, language, or learning
  • Adult with legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chru Tours

Tours, 37044, France

RECRUITING

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Frederique Bonnet-Brilhault, PhD

CONTACT

0247473846f.bonnet-brilhault@chu-tours.fr

Marie Gomot

CONTACT

0247478664gomot@univ-tours.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

June 9, 2017

Study Start

June 14, 2017

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 9, 2022

Record last verified: 2022-09

Locations

FR(1)