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Active, Not Recruiting

NCT Number: NCT06885060

Exploring Eye Vergence Markers ADHD) and ASD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGaze ADHD Diagnostic Test

Device

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

Device

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

Facical Emotion Computer Task

Device

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

Primary outcomes

  1. 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.

    Time frame: From enrollment of the first participant, through to study completion after 2 years.

Sponsors and collaborators

Lead sponsor

Elizabeth Kilbey

Other

Collaborators

  • Braingaze

Registry information

Official study title

Exploring Eye Vergence Markers in Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD).

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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