Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-45
SponsorUniversity Hospital, Tours

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Participants with no data to evaluate Outcome 1

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 4 trial groups
Group A: Neurodevelopmental Disorders Children
Group B: Neurodevelopmental Disorders Adults
Group C: Neurotypical Children
Group D: Neurotypical Adults

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Tours

Lead sponsor

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

Collaborator