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

Sponsor
University Hospital, Tours (Other)
Overall Status
Recruiting
CT.gov ID
NCT03182400
Collaborator
(none)
450
1
1
62.6
7.2

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Neurophysiological assessment
  • Behavioral: Neuropsychological assessment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Neurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults
Actual Study Start Date :
Jun 14, 2017
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. ERP amplitude (µV) [1 hour]

    analysis of ERP amplitude evoked during EEG recording

Secondary Outcome Measures

  1. Reaction times (ms) [1 hour]

    Reaction times collected during behavioral assessment

  2. pupil size (mm) [1 hour]

    pupil size measurements acquired with the eye tracker

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chru Tours Tours France 37044

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT03182400
Other Study ID Numbers:
  • PHAO17-FBB/PROSCEA
First Posted:
Jun 9, 2017
Last Update Posted:
Jun 3, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 3, 2021