Identification of Early Biomarkers of Pre-school ADHD

Conditions

• ADHD

Eligibility Criteria

Sex

ALL

Age

3 Years - 5 Years

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

First listed

Feb 27, 2026

Start date

Mar 1, 2026

Status verified

Feb 2026

Primary completion

Mar 1, 2027

Completion

Mar 1, 2028

Study Design

Enrollment

60 participants (estimated)

Arms

• Arm: Patient
  ADHD patients group: Assessement at V0 et V12 months Review of inclusion and non-inclusion criteria * Neuropsychological assessment: WPPSI-IV; K-CPT * Self-questionnaires: ADHD-RS preschool version, temperament scale (CBQ) * Experimental evaluation: Eye movement recording, vestibular examination, postural recording, VVS test
• Arm: 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 * Neuropsychological assessment: WPPSI-IV; K-CPT * Self-questionnaires: ADHD-RS preschool version, temperament scale (CBQ) * Experimental evaluation: Eye movement recording, vestibular examination, postural recording, VVS test

Primary Outcome Measure

Scores obtained in eye tracking tests between the ADHD group and the control group (fixation duration) [ Time Frame: At baseline ]

Central Contacts

• Ana MOSCOSO, MD
  +33(0)1 40 03 22 95
  [email protected]

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