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Attention Deficit Hyperactivity Disorder (ADHD)NCT06885060

Exploring Eye Vergence Markers ADHD) and ASD

An observational study of Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD), run by Elizabeth Kilbey at 3 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 years and olderHealthy volunteers can take part
What is being tested?
BGaze ADHD Diagnostic Test, Oddball/Alerting Computer Task and Facical Emotion Computer Task
Type of treatment
Medical device
How many people
200 participants
Where
3 sitesin 2 countries
Study dates
1 Feb 2025to 31 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Individuals from the Southeast of England, who are able to travel to either New Malden or Beckenham to partake in the study.

Who may be able to join

  • 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.

Who cannot join

  • Those with non-corrected vision - e.g. near-sightedness, far-sightedness, strabismus or nystagmus
  • Individuals with any other oculomotor deficiency, blindness or vision loss.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United Kingdom2 sites
  • The Dr Kilbey Practice

    Beckenham, London, BR3 5AA

  • Child and Adult Neurodevelopment Assessment Ltd

    New Malden, London, KT3 4BH

Other trials in United Kingdom

Spain1 site
  • Braingaze SL

    Barcelona, Catalonia, 08302

Other trials in Spain

About this study

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

Read more

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.

Being tested
BGaze ADHD Diagnostic Test, Oddball/Alerting Computer Task, Facical Emotion Computer Task
Keywords
ADHD, ASD, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Autism, Inattention, Impulsivity, Eye Vergence, Eye Tracking, Hyperactivity, Cognitive Eye Vergence, BGaze Clinic, Bio-marker
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder, Autistic Disorder, Impulsive Behavior, Spasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGaze ADHD Diagnostic TestDevice

    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 TaskDevice

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

  • Facical Emotion Computer TaskDevice

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

Study groups in NCT06885060
Study groupRoleWhat they receive
ADHD GroupPatients who have a diagnosis of ADHD (but not ASD), either prior to, or diagnosed during, the duration of their participation in the study.
Receives: Device: BGaze ADHD Diagnostic Test; Device: Oddball/Alerting Computer Task; Device: Facical Emotion Computer Task
ASD GroupPatients who have a diagnosis of ASD (but not ADHD), either prior to, or diagnosed during, the duration of their participation in the study.
Receives: Device: BGaze ADHD Diagnostic Test; Device: Oddball/Alerting Computer Task; Device: Facical Emotion Computer Task
Combined GroupPatients who have a combined diagnosis of ADHD and ASD, either prior to, or diagnosed during, the duration of their participation in the study.
Receives: Device: BGaze ADHD Diagnostic Test; Device: Oddball/Alerting Computer Task; Device: Facical Emotion Computer Task
Control GroupPatients who do not have a diagnosis of neither ADHD and/or ASD, and do not show traits of either diagnosis.
Receives: Device: BGaze ADHD Diagnostic Test; Device: Oddball/Alerting Computer Task; Device: Facical Emotion Computer Task

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start1 Feb 2025
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885060
Sponsor's protocol ID
347961
Status last verified
Feb 2026
First submitted
7 Mar 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Romeo A, Leonovych O, Sole Puig M, Super H. Cognitive Vergence Recorded with a Webcam-Based Eye-Tracker during an Oddball Task in an Elderly Population. Sensors (Basel). 2024 Jan 30;24(3):888. doi: 10.3390/s24030888.

    PubMed 38339605
  • Hashemi, A. et al. (2023) 'Classification of MCI patients using vergence eye movements and pupil responses obtained during a visual oddball test', Aging and Health Research, 3(1), p. 100121. Available at: https://doi.org/10.1016/j.ahr.2023.100121

  • Bast N, Boxhoorn S, Super H, Helfer B, Polzer L, Klein C, Cholemkery H, Freitag CM. Atypical Arousal Regulation in Children With Autism but Not With Attention-Deficit/Hyperactivity Disorder as Indicated by Pupillometric Measures of Locus Coeruleus Activity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Jan;8(1):11-20. doi: 10.1016/j.bpsc.2021.04.010. Epub 2021 Apr 27.

    PubMed 33930603
  • Bustos-Valenzuela, P. et al. (2022) 'Atypical cognitive vergence responses in children with attention deficit hyperactivity disorder but not with autism spectrum disorder in a facial emotion recognition task', Psychiatry Research Communications, 2(2), p. 100045. Available at: https://doi.org/10.1016/j.psycom.2022.100045

  • Jimenez EC, Sierra-Marcos A, Romeo A, Hashemi A, Leonovych O, Bustos Valenzuela P, Sole Puig M, Super H. Altered Vergence Eye Movements and Pupil Response of Patients with Alzheimer's Disease and Mild Cognitive Impairment During an Oddball Task. J Alzheimers Dis. 2021;82(1):421-433. doi: 10.3233/JAD-201301.

    PubMed 34024820
  • Jimenez EC, Avella-Garcia C, Kustow J, Cubbin S, Corrales M, Richarte V, Esposito FL, Morata I, Perera A, Varela P, Canete J, Faraone SV, Super H, Ramos-Quiroga JA. Eye Vergence Responses During an Attention Task in Adults With ADHD and Clinical Controls. J Atten Disord. 2021 Jul;25(9):1302-1310. doi: 10.1177/1087054719897806. Epub 2020 Jan 20.

    PubMed 31959011
  • Sole Puig M, Romeo A, Super H. Vergence eye movements during figure-ground perception. Conscious Cogn. 2021 Jul;92:103138. doi: 10.1016/j.concog.2021.103138. Epub 2021 May 19.

    PubMed 34022640
  • Jimenez EC, Romeo A, Perez Zapata L, Sole Puig M, Bustos-Valenzuela P, Canete J, Varela Casal P, Super H. Eye vergence responses in children with and without reading difficulties during a word detection task. Vision Res. 2020 Apr;169:6-11. doi: 10.1016/j.visres.2020.02.001. Epub 2020 Mar 3.

    PubMed 32143068
  • Boxhoorn S, Bast N, Super H, Polzer L, Cholemkery H, Freitag CM. Pupil dilation during visuospatial orienting differentiates between autism spectrum disorder and attention-deficit/hyperactivity disorder. J Child Psychol Psychiatry. 2020 May;61(5):614-624. doi: 10.1111/jcpp.13179. Epub 2019 Dec 18.

    PubMed 31853987
  • Esposito FL, Super H. Eye vergence responses to novel and familiar stimuli in young children. Acta Psychol (Amst). 2019 Feb;193:190-196. doi: 10.1016/j.actpsy.2019.01.007. Epub 2019 Jan 15.

    PubMed 30654274
  • Esposito FL, Super H. Vergence responses to face stimuli in young children. Neuroreport. 2018 Feb 7;29(3):219-223. doi: 10.1097/WNR.0000000000000963.

    PubMed 29324520
  • Super, H. et al. (2017) 'Neurobiological marker for child and adult ADHD diagnoses', European Psychiatry, 41(S1), pp. S454-S455. Available at: https://doi:10.1016/j.eurpsy.2017.01.489

  • Sole Puig M, Romeo A, Canete Crespillo J, Super H. Eye vergence responses during a visual memory task. Neuroreport. 2017 Feb 8;28(3):123-127. doi: 10.1097/WNR.0000000000000734.

    PubMed 28121809
  • Sole Puig M, Pallares JM, Perez Zapata L, Puigcerver L, Canete J, Super H. Attentional Selection Accompanied by Eye Vergence as Revealed by Event-Related Brain Potentials. PLoS One. 2016 Dec 14;11(12):e0167646. doi: 10.1371/journal.pone.0167646. eCollection 2016.

    PubMed 27973591
  • Sole Puig M, Perez Zapata L, Puigcerver L, Esperalba Iglesias N, Sanchez Garcia C, Romeo A, Canete Crespillo J, Super H. Attention-Related Eye Vergence Measured in Children with Attention Deficit Hyperactivity Disorder. PLoS One. 2015 Dec 22;10(12):e0145281. doi: 10.1371/journal.pone.0145281. eCollection 2015.

    PubMed 26694162

Questions about this trial

What is this clinical trial studying?

An observational study of Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD), run by Elizabeth Kilbey at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06885060, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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