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

Healthy Volunteer Clinical Trial

— PROSCEA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03182400
• Other study ID #: PHAO17-FBB/PROSCEA
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: June 2027

Study information

• Verified date: September 2022
• Source: University Hospital, Tours
• Contact: Frederique Bonnet-Brilhault, PhD
• Phone: 0247473846
• Email: f.bonnet-brilhault[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Behavioral:
• Neurophysiological assessment
Assessment of cerebral electrical activity Assessment of ocular exploration Neurovegetative assessments
• Neuropsychological assessment
sub-tests, scales, surveys, reaction time measurement

Locations

Country	Name	City	State
France	Chru 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	ERP amplitude (µV)	analysis of ERP amplitude evoked during EEG recording	1 hour
Secondary	Reaction times (ms)	Reaction times collected during behavioral assessment	1 hour
Secondary	pupil size (mm)	pupil size measurements acquired with the eye tracker	1 hour