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

NCT03182400 — Not applicable, Recruiting, 450 participants, University Hospital, Tours

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RegistryNCT03182400, acronym PROSCEA
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, basic science
Enrollment450 (Estimated)
SponsorUniversity Hospital, Tours (Other)
ConditionsHealthy Volunteer
InterventionsNeurophysiological assessment, Neuropsychological assessment (Behavioral)
Datesstart 2017-06-14, primary completion 2027-06-01 (estimated), completion 2027-06-01 (estimated), first posted 2017-06-09, last updated 2022-09-09
Locations1 site in France

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-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 .

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+Arms and interventions

ArmTypeInterventionsDescription
Healthy volunteerExperimentalBehavioral: Neurophysiological assessment; Behavioral: Neuropsychological assessmentNeurophysiological assessment Neuropsychological assessment
  • Neurophysiological assessment (Behavioral): Assessment of cerebral electrical activity Assessment of ocular exploration Neurovegetative assessments
  • Neuropsychological assessment (Behavioral): sub-tests, scales, surveys, reaction time measurement

+Outcome measures

Primary outcomes

  • ERP amplitude (µV) [1 hour]: analysis of ERP amplitude evoked during EEG recording

Secondary outcomes

  • Reaction times (ms) [1 hour]: Reaction times collected during behavioral assessment
  • pupil size (mm) [1 hour]: pupil size measurements acquired with the eye tracker

+Eligibility

Sex: All, ages: 1 Year to 60 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Chru ToursToursFranceRecruiting

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