About this trial
Attention Deficit Hyperactivity Disorder (ADHD) affects more than 5 % of children and adolescents, with a globally increasing prevalence. The condition imposes a significant burden on affected individuals, their families, and healthcare systems. Early and accurate diagnosis is crucial to ensure timely therapeutic and educational interventions. However, current diagnostic practices rely heavily on clinical interviews and behavioral observations, which are inherently subjective and resource-intensive.
There is a growing need for objective diagnostic tools that can complement or even partially replace current clinical assessments. One promising approach involves eye-tracking technology, as ADHD is associated with altered oculomotor control and attention-related neural circuits. These changes may be reflected in measurable eye movement parameters, including saccadic latency and fixation stability.
This clinical investigation uses a certified, CE-marked medical eye-tracking device (neos™) to assess whether specific eye movement parameters can serve as objective biomarkers for ADHD. Although the device was originally designed to assess visual pathway integrity, it also captures parameters related to attention and executive function through standardized protocols. The test is examiner-independent, non-invasive, and takes approximately 10 minutes.
The study is observational and non-interventional, involving two groups of participants aged 8 to 16: 50 children with a clinically confirmed diagnosis of ADHD and 50 age-matched non-ADHD controls. All participants will complete a single neos™ eye-tracking assessment.
The primary hypothesis is that children with ADHD will demonstrate greater variability in saccadic latency and a higher frequency of large saccades (\> 3°) during fixation compared to controls. These differences will be analyzed as potential diagnostic biomarkers. Diagnostic accuracy will be evaluated using receiver operating characteristic (ROC) analysis, with sensitivity, specificity and area under the curve (AUC) values reported.
Secondary hypotheses include:
Oculomotor parameters derived from the neos™ system can distinguish between ADHD subtypes (predominantly inattentive, hyperactive-impulsive and combined).
Combined oculomotor metrics correlate with ADHD symptom severity, potentially enabling a quantitative assessment of disease burden.
The results of this study could pave the way for the clinical adoption of objective, scalable and rapid diagnostic tools for ADHD. Beyond clinical use, such tools may also be adapted for population screening, telemedicine or integration into consumer-grade technologies such as virtual reality headsets. By validating a market-approved device for a new mental health indication, this study represents a critical step toward bridging research and clinical application in ADHD diagnostics.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinically confirmed diagnosis of ADHD by an expert (e.g., pediatrician, neuropsychologist, pediatric neurologist)
Age between 8 and 16 years
Written informed consent from the participant and/or legal guardian
Age between 8 and 16 years
Disqualifiers
Medical conditions known to affect ocular motor behavior (e.g., neurological or ophthalmological disorders)
Doubts regarding the accuracy of the ADHD diagnosis (for the ADHD group)
Lack of or questionable informed consent
Suspicion of ADHD in control group participants (reported by parents, examiner, or physician)
Trial population
The study population consists of children aged 8 to 16 years. Two groups will be included: children with a clinically confirmed diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and age-matched children without ADHD. Participants will be recruited from pediatric and ophthalmologic clinics. Both male and female children are eligible. Informed consent will be obtained from participants and/or their legal guardians.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Saccade frequency during fixation
Number of saccades (eye movements \> 3°) made during a fixation task. This frequency is hypothesized to be higher in children with ADHD than in controls.
Variability of saccadic latency
Variability in the time it takes for participants to initiate saccadic eye movements in response to visual stimuli. This parameter is expected to be higher in children with ADHD compared to controls.
Sensitivity and Specificity of Composite Oculomotor Biomarker for ADHD Diagnosis
Diagnostic sensitivity and specificity of a composite oculomotor biomarker derived from variables predictive of ADHD. Thresholds for individual parameters (e.g. saccadic latency variability \> 110 ms, saccade frequency during fixation \> 10/minute) will be based on literature and refined using internal study data prior to confirmatory analysis. Thresholds and analysis procedures will be pre-specified in the Statistical Analysis Plan.
Secondary outcomes
Discrimination Between ADHD Subtypes Using Multivariable Model Based on neos™ Eye-Tracking Parameters
A multivariable model based on neos™ eye-tracking parameters will be used to distinguish between the three ADHD subtypes: predominantly hyperactive-impulsive, predominantly inattentive and combined subtype. The model will incorporate all available neos™ eye-tracking data. Subtype classification performance (e.g. accuracy, sensitivity and specificity) will be evaluated based on internal validation procedures.
Correlation of Disease Severity with Oculomotor Biomarker for ADHD Severity Assessment
Disease severity in ADHD will be assessed in relation to a combined analysis of ocular motor parameters obtained via neos™ eye-tracking. The goal is to establish a new quantitative biomarker for ADHD severity. The correlation between oculomotor metrics and standardized clinical severity ratings (e.g. ADHD symptom scales) will be evaluated.
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