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RecruitingNCT07542977SensAUryUpdated Jun 16, 2026

Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders

An observational study in Neurodevelopmental Disorders, sponsored by University Hospital, Tours. Recruiting at 1 site in France. Open to participants aged 6 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by University Hospital, Tours · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
6 Years to 45 Years
Sex
All
01

Study summary

The goal of this observational study is to evaluate intra-individual neurophysiological variability in children and adults with and without NeuroDevelopmental Disorders (NDD), for several sensory modalities and types of stimulation. The main hypotheses are:

  • NDD participants and children exhibit higher intra-individual variability than other participants
  • intra-individual neurophysiological variability is correlated to behavioral, psychological and learning profiles

Participants in this study will:

  • be recorded for EEG and other neurophysiological parameters while exposed to sensory stimulations, to quantify sensory neurophysiological variability
  • perform behavioral tests and fill out questionnaires, to establish the behavioral and psychological profile
  • train for perceptual learning, to measure learning abilities

These evaluations will be split in 3 visits spread on a maximum of 3 months, and training for learning will be done at home in between 2 visits.

02

Conditions studied

  • Neurodevelopmental Disorders

Keywords

  • Sensory
  • Neurophysiology
  • Profile
03

Who can participate

Ages eligible
6 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants will be adults between 18 and 45 years old and children between 6 and 12 years old, with or without a Neurodevelopmental Disorder.

Eligibility criteria

Inclusion Criteria:

  • Social security affiliation
  • Free and written informed consent from the participants (Neurotypical Adults, NDD Adults without judicial protective measures), or their tutor or legal representant(s) (other participants)
  • Age between 6 and 12 years included (Children) or between 18 and 45 years included (Adults)
  • For NDD participants: NDD diagnosis by a qualified medical professional, according to DSM-4, DSM-5, ICD-10 or ICD-11 criteria

Non-inclusion Criteria:

  • Psychotropic medication perturbing EEG recording
  • Drugs pertubing peripheral neurophysiological measures
  • Non-corrected visual or auditory troubles
  • Known neurological or psychiatric conditions (at the exclusion of NDD for NDD participants)
  • Epilepsy
  • Inclusion in another ongoing medical protocol
  • For Neurotypical participants: NDD diagnosis
  • For NDD participants: anticipated psychological or physical risk at participating, at the investigator's discretion

Exclusion Criteria:

  • Participants with no data to evaluate Outcome 1
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Neurodevelopmental Disorders Children

    6-12 years old children

  • Neurodevelopmental Disorders Adults

    18-45 years old adults

  • Neurotypical Children

    6-12 years old children

  • Neurotypical Adults

    18-45 years old adults

05

What researchers measure

Primary outcomes

  1. Amplitude of central neurophysiological responses to sensory stimulations

    Amplitude (in micro-volts) of event-related potentials

    Time frame: Through study completion, an average of 2 months per participant

  2. Latency of central neurophysiological responses to sensory stimulations

    Latency (in milli-seconds) of event-related potentials

    Time frame: Through study completion, an average of 2 months per participant

  3. Variability of central neurophysiological responses to sensory stimulations

    Intra-individual variability (in percentage) of event-related potentials

    Time frame: Through study completion, an average of 2 months per participant

Secondary outcomes

  1. Visual perceptual learning performance

    Discrimination performance (in percentage) for visual delayed-matching to sample task

    Time frame: Through study completion, an average of 2 months per participant

  2. Auditory perceptual learning performance

    Discrimination performance (in percentage) for auditory delayed-matching to sample task

    Time frame: Through study completion, an average of 2 months per participant

  3. Behavioral sensory profile

    Score (in absolute score) for psychomotor evaluation (Échelle des Particularités Sensori-psychomotrices dans l'Autisme)

    Time frame: Through study completion, an average of 2 months per participant

  4. Sensory profile questionnaire

    Score (in absolute score) for sensory questionnaire (Dunn Sensory Profile)

    Time frame: Through study completion, an average of 2 months per participant

  5. Cognitive psychological profile

    Score (in absolute score) for cognitive test (Raven's Progressive Matrices)

    Time frame: Through study completion, an average of 2 months per participant

  6. Executive functions questionnaire

    Score (in absolute score) for executive functions questionnaire (BRIEF or BRIEF-A depending on the group)

    Time frame: Through study completion, an average of 2 months per participant

  7. Attentional functions questionnaire

    Score (in absolute score) for attentional functions questionnaire (SNAP-IV-26 or ASRS-V1.1 depending on the group)

    Time frame: Through study completion, an average of 2 months per participant

  8. Socio-emotional questionnaire

    Score (in absolute score) for socio-emotional questionnaire (AQ)

    Time frame: Through study completion, an average of 2 months per participant

  9. Linguistic profile

    Score (in absolute score) for non-words and sentences repetition (LITMUS)

    Time frame: Through study completion, an average of 2 months per participant

  10. Heart beat response to sensory stimulations

    Heart beat variation (in milliseconds) following sensory stimulation, recorded simultaneously with EEG

    Time frame: Through study completion, an average of 2 months per participant

  11. Electrodermal activity response to sensory stimulations

    Electrodermal activity variation (in microsiemens) following sensory stimulation, recorded simultaneously with EEG

    Time frame: Through study completion, an average of 2 months per participant

  12. Pupillary response to sensory stimulations

    Pupillary diameter variation (in millimeter) following sensory stimulation,recorded simultaneously with EEG

    Time frame: Through study completion, an average of 2 months per participant

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT07542977
Lead sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Apr 21, 2026
Start date
May 7, 2026
Primary completion
Jul 15, 2026 (estimated)
Completion
Jun 15, 2028 (estimated)
Last update
Jun 16, 2026

Study contacts

Claire WARDAK, Dr
Contact
claire.wardak@univ-tours.fr
02 47 47 97 47
Adeline MOUSSET
Contact
a.fourmy@chu-tours.fr
0218370645

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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