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NCT Number: NCT03182400

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

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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Key information

Conditions

Age range

1 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chru Tours

Tours, 37044, France

Location status: Recruiting

Location contact

Frederique Bonnet-Brilhault, PhD

PRINCIPAL_INVESTIGATOR

Marie Gomot

CONTACT

[email protected]

0247478664

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurophysiological assessment

Behavioral

Assessment of cerebral electrical activity Assessment of ocular exploration Neurovegetative assessments

Neuropsychological Assessment

Behavioral

sub-tests, scales, surveys, reaction time measurement

Primary outcomes

  1. ERP amplitude (µV)

    Time frame: 1 hour

    analysis of ERP amplitude evoked during EEG recording

Secondary outcomes

  1. Reaction times (ms)

    Time frame: 1 hour

    Reaction times collected during behavioral assessment

  2. pupil size (mm)

    Time frame: 1 hour

    pupil size measurements acquired with the eye tracker

Study contacts

Contact information is provided by the study sponsor or research team.

Frederique Bonnet-Brilhault, PhD

CONTACT

[email protected]

0247473846

Marie Gomot

CONTACT

[email protected]

0247478664

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: PROSCEA

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2017
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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