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Recruiting NCT03182400

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

No phase Interventional Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neurophysiological assessment, Neuropsychological assessment.
Who it may be relevant to
Registry conditions: Healthy Volunteer. Basic parameters: 1 year — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 .

Interventions

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

Primary outcome measures

  • ERP amplitude (µV) [Time frame: 1 hour]
Secondary outcome measures (2)
  • Reaction times (ms) [Time frame: 1 hour]
  • pupil size (mm) [Time frame: 1 hour]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Chru Tours — Tours

Identifiers

NCT: NCT03182400 · PHAO17-FBB/PROSCEA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗