Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders (SensAUry)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurodevelopmental Disorders

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Adeline MOUSSET; Phone Number: 0218370645; Email: a.fourmy@chu-tours.fr
• Study Contact Backup: Name: Claire WARDAK, Dr; Phone Number: 02 47 47 97 47; Email: claire.wardak@univ-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude of central neurophysiological responses to sensory stimulations	Amplitude (in micro-volts) of event-related potentials	Through study completion, an average of 2 months per participant
Latency of central neurophysiological responses to sensory stimulations	Latency (in milli-seconds) of event-related potentials	Through study completion, an average of 2 months per participant
Variability of central neurophysiological responses to sensory stimulations	Intra-individual variability (in percentage) of event-related potentials	Through study completion, an average of 2 months per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual perceptual learning performance	Discrimination performance (in percentage) for visual delayed-matching to sample task	Through study completion, an average of 2 months per participant
Auditory perceptual learning performance	Discrimination performance (in percentage) for auditory delayed-matching to sample task	Through study completion, an average of 2 months per participant
Behavioral sensory profile	Score (in absolute score) for psychomotor evaluation (Échelle des Particularités Sensori-psychomotrices dans l'Autisme)	Through study completion, an average of 2 months per participant
Sensory profile questionnaire	Score (in absolute score) for sensory questionnaire (Dunn Sensory Profile)	Through study completion, an average of 2 months per participant
Cognitive psychological profile	Score (in absolute score) for cognitive test (Raven's Progressive Matrices)	Through study completion, an average of 2 months per participant
Executive functions questionnaire	Score (in absolute score) for executive functions questionnaire (BRIEF or BRIEF-A depending on the group)	Through study completion, an average of 2 months per participant
Attentional functions questionnaire	Score (in absolute score) for attentional functions questionnaire (SNAP-IV-26 or ASRS-V1.1 depending on the group)	Through study completion, an average of 2 months per participant
Socio-emotional questionnaire	Score (in absolute score) for socio-emotional questionnaire (AQ)	Through study completion, an average of 2 months per participant
Linguistic profile	Score (in absolute score) for non-words and sentences repetition (LITMUS)	Through study completion, an average of 2 months per participant
Heart beat response to sensory stimulations	Heart beat variation (in milliseconds) following sensory stimulation, recorded simultaneously with EEG	Through study completion, an average of 2 months per participant
Electrodermal activity response to sensory stimulations	Electrodermal activity variation (in microsiemens) following sensory stimulation, recorded simultaneously with EEG	Through study completion, an average of 2 months per participant
Pupillary response to sensory stimulations	Pupillary diameter variation (in millimeter) following sensory stimulation,recorded simultaneously with EEG	Through study completion, an average of 2 months per participant

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): April 15, 2028

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Neurophysiology; Sensory; Profile
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: DR240270

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No