Neurodevelopmental DisordersSensAUryNCT07542977
Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders
An observational study of Neurodevelopmental Disorders, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2026to 15 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
- For Neurotypical participants: NDD diagnosis
- For NDD participants: anticipated psychological or physical risk at participating, at the investigator's discretion
Who cannot join
- Participants with no data to evaluate Outcome 1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
WARDAK
Tours, 37000
Claire WARDAK, Dr, claire.wardak@univ-tours.fr
About this study
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
Read more
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
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of central neurophysiological responses to sensory stimulations
Amplitude (in micro-volts) of event-related potentials
Measured: 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
Measured: 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
Measured: Through study completion, an average of 2 months per participant
Secondary outcomes (12)
Visual perceptual learning performance
Discrimination performance (in percentage) for visual delayed-matching to sample task
Measured: 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
Measured: 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)
Measured: Through study completion, an average of 2 months per participant
Sensory profile questionnaire
Score (in absolute score) for sensory questionnaire (Dunn Sensory Profile)
Measured: Through study completion, an average of 2 months per participant
Cognitive psychological profile
Score (in absolute score) for cognitive test (Raven's Progressive Matrices)
Measured: 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)
Measured: 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)
Measured: Through study completion, an average of 2 months per participant
Socio-emotional questionnaire
Score (in absolute score) for socio-emotional questionnaire (AQ)
Measured: Through study completion, an average of 2 months per participant
Linguistic profile
Score (in absolute score) for non-words and sentences repetition (LITMUS)
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 2 months per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start7 May 2026
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542977
- Sponsor's protocol ID
- DR240270
- Acronym
- SensAUry
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT07542977
- Acronym / sponsor ID
- SensAUry / DR240270
- Conditions
- Neurodevelopmental Disorders
- Keywords
- Sensory, Neurophysiology, Profile
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 7 May 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- Participants with no data to evaluate Outcome 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire WARDAK, Dr (02 47 47 97 47, claire.wardak@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of central neurophysiological responses to sensory stimulations (time frame: Through study completion, an average of 2 months per participant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.