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Active, not recruiting Observational

Exploring Eye Vergence Markers ADHD) and ASD

NCT06885060 · tracked via the Priya Life Science Spain tracker
Sponsor
Elizabeth Kilbey
Phase
Observational
Started
2025-02-01
Last updated
2026-02-03

Condition(s) studied

Attention Deficit Hyperactivity Disorder (ADHD)Autism Spectrum Disorder (ASD)

Investigational drug(s) / intervention(s)

BGaze ADHD Diagnostic TestOddball/Alerting Computer TaskFacical Emotion Computer Task

BGaze ADHD Diagnostic Test: The BGaze Clinic ADHD diagnostic test will be administered to all participants. This involves a computer-based task, where an eye-tracker will be recording their eye-movements.

Oddball/Alerting Computer Task: Oddball/Alerting Computer Task will be completed by all participants while an eye-tracker records their eye movements.

Facical Emotion Computer Task: The Facial Emotion Computer Task will also be completed by all participants while their eye movements are recorded using an eye-tracker.

Study summary

The investigators study aims to evaluate the utility of eye vergence, an eye-tracking measure, as an indicator of visuo-spatial attention in children aged 4-17 years and adults, using computer-based eye-tracking tasks. Eye vergence, a binocular movement crucial for depth perception, has recently been linked to attentional control and neurodevelopmental conditions (NDCs) like ADHD and ASD. The investigators will work with children and adults from the CAN and Beckenham clinical centres to explore the relationship between eye vergence and diagnostic categories, potentially identifying subgroups with specific or overlapping attentional differences. This research may aid in the early detection of attention deficits, informing targeted treatments.

The investigators will compare neuropsychological and behavioural data from routine clinical sessions with neurophysiological data collected via eye-tracking in a large sample of children aged 7-17 and adults with ADHD and ASD. These clinical measures are well-validated. The study will assess the modulation of eye vergence, pupil size, and head movements across tasks that target different attentional processes, such as orienting, disengaging, inhibiting, and sustaining attention. These tasks will be adapted from both Braingaze's battery and other validated eye-tracking tasks.

Additionally, the investigators will explore whether AI can enhance the accuracy of rating scales and questionnaires used to measure ADHD and ASD symptoms in children and adults. With consent, the investigators will use data from previously diagnosed patients collected during routine assessments at the CAN and Beckenham centres.

The investigators will also test the accuracy of using a smartphone selfie camera as an eye tracker. In a subset of 50 children (25 clinical and 25 controls), the investigators will evaluate this technology for its ability to measure eye vergence and identify attentional differences.

This study qualifies as basic science because it aims to explore fundamental mechanisms of eye vergence and its relationship with attention, rather than evaluating or marketing a medical device for diagnosis or treatment. The primary objective is to understand how eye vergence, as a neurophysiological measure, correlates with attentional processes in individuals with ADHD and ASD. Although the study utilizes an eye-tracking device, it does so as a research tool to collect data on visual and cognitive processes. The focus is on expanding the knowledge of cognitive function and attention regulation in neurodevelopmental conditions, not on testing or validating the device for clinical use. This distinction makes the study appropriate for review by the receiving REC as basic scientific research, rather than as a clinical trial of a medical device.

Eligibility

Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Clinical Groups: Patients currently undergoing or who have previously undergone an assessment for either ADHD and/or Autism at either the CAN centre or Dr Kilbey's private practice in Beckenham. * Control Group: Subjects without a diagnosis of either ADHD nor Autism, who show no traits of these conditions. * People of any gender/sex who are aged older than 6 years old. Exclusion Criteria: * Those with non-corrected vision - e.g. near-sightedness, far-sightedness, strabismus or nystagmus * Individuals with any other oculomotor deficiency, blindness or vision loss.

Primary outcome measure(s)

  • To evaluate the sensitivity and specificity of cognitive eye vergence data, gathered using eye-tracking, for correctly identifying specific attentional deficits in patients with NDCs such as ADHD and ASD. — From enrollment of the first participant, through to study completion after 2 years.

Trial sites (3)

FacilityCityRegionStatus
Braingaze SL Barcelona Catalonia
The Dr Kilbey Practice Beckenham London
Child and Adult Neurodevelopment Assessment Ltd New Malden London
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06885060 on ClinicalTrials.gov ↗ ← All trials in Spain