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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01707-42 | Other Identifier | ANSM |
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ADHD affects around 5% of children and manifests itself as hyperactivity, attention difficulties and motor control and balance problems. The prevalence of ADHD is particularly high in certain populations, affecting up to 25-30% of children born prematurely and around 20% of children with neurological conditions such as epilepsy. This disorder is officially diagnosed from the age of 6, according to current criteria. However, its clinical manifestations appear much earlier, having a significant impact on all aspects of the child's life, particularly in the most severe forms, which are often unrecognised due to a lack of clinical resources, and therefore without appropriate treatment.
The creation of a platform dedicated to children at risk of ADHD will enable specific clinical expertise to be developed, with the aim of proposing early targeted interventions and positively influencing the development of their trajectory. This platform will also aim to develop new diagnostic methods, based on indirect measures of attentional and executive processes, balance and the development of a risk measurement scale. This development is essential, as the assessment tools currently available lack specificity.
In order to demonstrate the reliability of the innovative diagnostic methods proposed, a comparative pilot study between children from the first clinical cohort (N=30) and a group of healthy children of the same age (N=30) will be carried out. This will enable us to study the discrimination of our tools and make any necessary adjustments. This pilot study also includes a longitudinal re-evaluation, at 12 months, of the children in the ADHD cohort, in order to study changes in these biomarkers over time.
ADHD and control patients will be informed of the study at least 1 week before the inclusion visit.
During the inclusion visit, after consent has been obtained from those with parental authority, patients in both groups will be :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | ADHD patients group: Assessement at V0 et V12 months Review of inclusion and non-inclusion criteria
| ||
| Control | Control subjects group, with no know conditions or desease affecting development and behavior: assessement only at V0 Review of inclusion and non-inclusion criteria
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| Measure | Description | Time Frame |
|---|---|---|
| Scores obtained in eye tracking tests between the ADHD group and the control group (fixation duration) | Identification of biomarkers of visual attention by comparing scores obtained in eye-tracking tests between the ADHD group and the control group. | At baseline |
| Scores obtained in eye tracking tests between the ADHD group and the control group (latencies) | Identification of biomarkers of visual attention by comparing scores obtained in eye-tracking tests between the ADHD group and the control group | At baseline |
| Scores obtained in eye tracking tests between the ADHD group and the control group (number of errors) | Identification of biomarkers of visual attention by comparing scores obtained in eye-tracking tests between the ADHD group and the control group | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Scores obtained in vestibular tests in both groups and Progression at 12 months in the ADHD group (clinical exam) | Identifying biomarkers linked to vestibular function in ADHD children compared to controls | At baseline |
| Scores obtained in Subjective visual vertical test in both groups and Progression at 12 months in the ADHD group |
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Inclusion Criteria:
For control subjects:
Exclusion Criteria:
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30 children aged between 3 and 5 years and 11 months, with clinical criteria for ADHD, will be compared with 30 healthy children of the same age.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana MOSCOSO, MD | Contact | +33(0)1 40 03 22 95 | ana.moscoso@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Debré Hospital | Paris | 75019 | France |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Evaluate the diagnostic performance of the different biomarkers (visual and vestibular attention) in relation to the usual neuropsychological tests or self-questionnaires |
| At baseline & at 12 months |
| WPPSI (Wechsler Preschool and Primary Scale of Intelligence) sub-scores in both groups and Progression at 12 months in the ADHD group | Evaluate the diagnostic performance of the different biomarkers (visual and vestibular attention) in relation to the usual neuropsychological tests or self-questionnaires | At baseline & at 12 months |
| K-CPT (Conners Kiddie Continuous Performance) scores in both groups (impulsivity scores) and Progression at 12 months in the ADHD group | Evaluate the diagnostic performance of the different biomarkers (visual and vestibular attention) in relation to the usual neuropsychological tests or self-questionnaires | At baseline & at 12 months |
| Parent self-questionnaire scores in both groups and Progression at 12 months in the ADHD group | Evaluate the diagnostic performance of the different biomarkers (visual and vestibular attention) in relation to the usual neuropsychological tests or self-questionnaires | At baseline & at 12 months |