Neurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults (PROSCEA)

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 .

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Behavioral: Neurophysiological assessment; Behavioral: Neuropsychological assessment

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederique Bonnet-Brilhault, PhD; Phone Number: 0247473846; Email: f.bonnet-brilhault@chu-tours.fr
• Study Contact Backup: Name: Marie Gomot; Phone Number: 0247478664; Email: gomot@univ-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • Recruiting
    • Chru Tours
    • Contact: Marie Gomot; Phone Number: 0247478664; Email: gomot@univ-tours.fr
    • Principal Investigator: Frederique Bonnet-Brilhault, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 58 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Abnormal corrected vision
• Abnormal audition
• Known personal neurological pathology
• Known personal psychiatric problems
• Identified difficulties for walking, language, or learning
• Exclusion period because of participation to another experimental protocol
• Adult with legal protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteer; Neurophysiological assessment Neuropsychological assessment	Behavioral: Neurophysiological assessment; Assessment of cerebral electrical activity Assessment of ocular exploration Neurovegetative assessments; Behavioral: Neuropsychological assessment; sub-tests, scales, surveys, reaction time measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ERP amplitude (µV)	analysis of ERP amplitude evoked during EEG recording	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction times (ms)	Reaction times collected during behavioral assessment	1 hour
pupil size (mm)	pupil size measurements acquired with the eye tracker	1 hour

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Anticipated): June 1, 2027
• Study Completion (Anticipated): June 1, 2027

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PHAO17-FBB/PROSCEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No