NCT07542977 - Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders | Crick | Crick

Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders

N/ANot Yet RecruitingNCT07542977

University Hospital, Tours200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Neurodevelopmental Disorders

Eligibility

Sex: ALLMin age: 6 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

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

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

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

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

Socio-emotional questionnaire

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

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

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

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

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

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