Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2025-02-01
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ADHD Group
Patients who have a diagnosis of ADHD (but not ASD), either prior to, or diagnosed during, the duration of their participation in the study.
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.
ASD Group
Patients who have a diagnosis of ASD (but not ADHD), either prior to, or diagnosed during, the duration of their participation in the study.
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.
Combined Group
Patients who have a combined diagnosis of ADHD and ASD, either prior to, or diagnosed during, the duration of their participation in the study.
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.
Control Group
Patients who do not have a diagnosis of neither ADHD and/or ASD, and do not show traits of either diagnosis.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Individuals with any other oculomotor deficiency, blindness or vision loss.
6 Years
ALL
Yes
Sponsors
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Braingaze
INDUSTRY
Elizabeth Kilbey
OTHER
Responsible Party
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Elizabeth Kilbey
Consultant Clinical Psychologist
Principal Investigators
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Hans A Super, BSc MSc PhD
Role: STUDY_DIRECTOR
Braingaze & University of Barcelona
Locations
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Braingaze SL
Barcelona, Catalonia, Spain
The Dr Kilbey Practice
Beckenham, London, United Kingdom
Child and Adult Neurodevelopment Assessment Ltd
New Malden, London, United Kingdom
Countries
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References
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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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
Sole Puig M, Puigcerver L, Aznar-Casanova JA, Super H. Difference in visual processing assessed by eye vergence movements. PLoS One. 2013 Sep 19;8(9):e72041. doi: 10.1371/journal.pone.0072041. eCollection 2013.
Sole Puig M, Perez Zapata L, Aznar-Casanova JA, Super H. A role of eye vergence in covert attention. PLoS One. 2013;8(1):e52955. doi: 10.1371/journal.pone.0052955. Epub 2013 Jan 31.
Related Links
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Braingaze Website
CAN Website
The Dr Kilbey Practice Website
Other Identifiers
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347961
Identifier Type: -
Identifier Source: org_study_id
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