A Quick and Reliable Eye Movement Test to Help Diagnose ADHD in Children.

NCT07136259 | Not Yet Recruiting

• 1 other identifier: 2025-D0052
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD); Attention Deficit Disorder (ADD)

Keywords

ADHD; Eye Tracking; Oculomotor Function; Pupillary Response; Pedriatic Neuropsychiatry; Neurodevelopmental Disorders; Neurocognitive Testing; Non-invasive Assessment; Eye Movements

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  At completion of baseline assessment (Day 0)

Secondary Outcomes (2)

• Discrimination Between ADHD Subtypes Using Multivariable Model Based on neos™ Eye-Tracking Parameters

  At the end of data collection and prior to final analysis (estimated Month 12)

• Correlation of Disease Severity with Oculomotor Biomarker for ADHD Severity Assessment

  Assessed at baseline visit (Day 0) - if everything is recorded

Study Arms (2)

Group 1

ADHD

Group 2

Control Children

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• For the ADHD group:
• 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
• For the control group (non-ADHD):
• Age between 8 and 16 years
• No suspicion of ADHD
• Written informed consent from the participant and/or legal guardian

You may not qualify if:

• For both groups:
• 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)

Sponsors & Collaborators

• Onovis Augenpraxis: lead

Study Sites (1)

OnovisAugenpraxis

Bern, Canton of Bern, 3011, Switzerland

Location

Related Publications (8)

• Wainstein G, Rojas-Libano D, Crossley NA, Carrasco X, Aboitiz F, Ossandon T. Pupil Size Tracks Attentional Performance In Attention-Deficit/Hyperactivity Disorder. Sci Rep. 2017 Aug 15;7(1):8228. doi: 10.1038/s41598-017-08246-w.

  PMID: 28811624 BACKGROUND

• Schulz-Zhecheva Y, Voelkle MC, Beauducel A, Biscaldi M, Klein C. Intra-Subject Variability, Intelligence, and ADHD Traits in a Community-Based Sample. J Atten Disord. 2023 Jan;27(1):67-79. doi: 10.1177/10870547221118523. Epub 2022 Sep 8.

  PMID: 36082454 BACKGROUND

• Salari N, Ghasemi H, Abdoli N, Rahmani A, Shiri MH, Hashemian AH, Akbari H, Mohammadi M. The global prevalence of ADHD in children and adolescents: a systematic review and meta-analysis. Ital J Pediatr. 2023 Apr 20;49(1):48. doi: 10.1186/s13052-023-01456-1.

  PMID: 37081447 BACKGROUND

• Munoz DP, Broughton JR, Goldring JE, Armstrong IT. Age-related performance of human subjects on saccadic eye movement tasks. Exp Brain Res. 1998 Aug;121(4):391-400. doi: 10.1007/s002210050473.

  PMID: 9746145 BACKGROUND

• Mostofsky SH, Lasker AG, Cutting LE, Denckla MB, Zee DS. Oculomotor abnormalities in attention deficit hyperactivity disorder: a preliminary study. Neurology. 2001 Aug 14;57(3):423-30. doi: 10.1212/wnl.57.3.423.

  PMID: 11502907 BACKGROUND

• Maron DN, Bowe SJ, Spencer-Smith M, Mellahn OJ, Perrykkad K, Bellgrove MA, Johnson BP. Oculomotor deficits in attention deficit hyperactivity disorder (ADHD): A systematic review and comprehensive meta-analysis. Neurosci Biobehav Rev. 2021 Dec;131:1198-1213. doi: 10.1016/j.neubiorev.2021.10.012. Epub 2021 Oct 13.

  PMID: 34655657 BACKGROUND

• Hamed AM, Kauer AJ, Stevens HE. Why the Diagnosis of Attention Deficit Hyperactivity Disorder Matters. Front Psychiatry. 2015 Nov 26;6:168. doi: 10.3389/fpsyt.2015.00168. eCollection 2015.

  PMID: 26635643 BACKGROUND

• Constantino JN, Kennon-McGill S, Weichselbaum C, Marrus N, Haider A, Glowinski AL, Gillespie S, Klaiman C, Klin A, Jones W. Infant viewing of social scenes is under genetic control and is atypical in autism. Nature. 2017 Jul 20;547(7663):340-344. doi: 10.1038/nature22999. Epub 2017 Jul 12.

  PMID: 28700580 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders

Central Study Contacts

Mathias Abegg, PD Dr. med. Dr. sc. nat.

CONTACT

+41 79 936 88 34; mathias.abegg@hin.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CH (1)