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NCT Number: NCT07542977

Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders

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.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorders

Age range

6 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

WARDAK

Tours, 37000, France

Location status: Recruiting

Location contact

Claire WARDAK, Dr

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Amplitude of central neurophysiological responses to sensory stimulations

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

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

  2. Latency of central neurophysiological responses to sensory stimulations

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

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

  3. Variability of central neurophysiological responses to sensory stimulations

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

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

Secondary outcomes

  1. Visual perceptual learning performance

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

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

  2. Auditory perceptual learning performance

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

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

  3. Behavioral sensory profile

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

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

  4. Sensory profile questionnaire

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

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

  5. Cognitive psychological profile

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

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

  6. Executive functions questionnaire

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

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

  7. Attentional functions questionnaire

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

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

  8. Socio-emotional questionnaire

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

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

  9. Linguistic profile

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

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

  10. Heart beat response to sensory stimulations

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

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

  11. Electrodermal activity response to sensory stimulations

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

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

  12. Pupillary response to sensory stimulations

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

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

Study contacts

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

Adeline MOUSSET

CONTACT

[email protected]

0218370645

Claire WARDAK, Dr

CONTACT

[email protected]

02 47 47 97 47

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: SensAUry

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Apr 21, 2026
Registry last updated
Jun 16, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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