Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neurodevelopmental Disorders. Basic parameters: 6 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Primary outcome measures
- Amplitude of central neurophysiological responses to sensory stimulations [Time frame: Through study completion, an average of 2 months per participant]
- Latency of central neurophysiological responses to sensory stimulations [Time frame: Through study completion, an average of 2 months per participant]
- Variability of central neurophysiological responses to sensory stimulations [Time frame: Through study completion, an average of 2 months per participant]
Secondary outcome measures (12)
- Visual perceptual learning performance [Time frame: Through study completion, an average of 2 months per participant]
- Auditory perceptual learning performance [Time frame: Through study completion, an average of 2 months per participant]
- Behavioral sensory profile [Time frame: Through study completion, an average of 2 months per participant]
- Sensory profile questionnaire [Time frame: Through study completion, an average of 2 months per participant]
- Cognitive psychological profile [Time frame: Through study completion, an average of 2 months per participant]
- Executive functions questionnaire [Time frame: Through study completion, an average of 2 months per participant]
- Attentional functions questionnaire [Time frame: Through study completion, an average of 2 months per participant]
- Socio-emotional questionnaire [Time frame: Through study completion, an average of 2 months per participant]
- Linguistic profile [Time frame: Through study completion, an average of 2 months per participant]
- Heart beat response to sensory stimulations [Time frame: Through study completion, an average of 2 months per participant]
- Electrodermal activity response to sensory stimulations [Time frame: Through study completion, an average of 2 months per participant]
- Pupillary response to sensory stimulations [Time frame: Through study completion, an average of 2 months per participant]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- WARDAK — Tours
Identifiers
NCT: NCT07542977 · DR240270