Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders

NCT07542977 | Not Yet Recruiting

• 1 other identifier: DR240270
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neurodevelopmental Disorders

Keywords

Sensory; Neurophysiology; Profile

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Visual perceptual learning performance

  Through study completion, an average of 2 months per participant

• Auditory perceptual learning performance

  Through study completion, an average of 2 months per participant

• Behavioral sensory profile

  Through study completion, an average of 2 months per participant

• Sensory profile questionnaire

  Through study completion, an average of 2 months per participant

• Cognitive psychological profile

  Through study completion, an average of 2 months per participant

Study Arms (4)

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

Eligibility Criteria

• Age: 6 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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
• Psychotropic medication perturbing EEG recording
• Drugs pertubing peripheral neurophysiological measures
• Non-corrected visual or auditory troubles
• Epilepsy
• For Neurotypical participants: NDD diagnosis
• For NDD participants: anticipated psychological or physical risk at participating, at the investigator's discretion

You may not qualify if:

• Participants with no data to evaluate Outcome 1

Sponsors & Collaborators

• University Hospital, Tours: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Claire WARDAK, Dr

CONTACT

02 47 47 97 47; claire.wardak@univ-tours.fr

Adeline MOUSSET

CONTACT

0218370645; a.fourmy@chu-tours.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 21, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): April 15, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04