跳至主要内容
临床试验/NCT06885060
NCT06885060进行中(未招募)不适用

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

Elizabeth Kilbey3 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2025年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
3
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

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.

干预措施: BGaze ADHD Diagnostic Test (Device)

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.

干预措施: Oddball/Alerting Computer Task (Device)

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.

干预措施: Facical Emotion Computer Task (Device)

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.

干预措施: BGaze ADHD Diagnostic Test (Device)

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.

干预措施: Oddball/Alerting Computer Task (Device)

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.

干预措施: Facical Emotion Computer Task (Device)

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.

干预措施: BGaze ADHD Diagnostic Test (Device)

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.

干预措施: Oddball/Alerting Computer Task (Device)

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.

干预措施: Facical Emotion Computer Task (Device)

Control Group

Patients who do not have a diagnosis of neither ADHD and/or ASD, and do not show traits of either diagnosis.

干预措施: BGaze ADHD Diagnostic Test (Device)

Control Group

Patients who do not have a diagnosis of neither ADHD and/or ASD, and do not show traits of either diagnosis.

干预措施: Oddball/Alerting Computer Task (Device)

Control Group

Patients who do not have a diagnosis of neither ADHD and/or ASD, and do not show traits of either diagnosis.

干预措施: Facical Emotion Computer Task (Device)

结局指标

主要结局

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.

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

次要结局

未报告次要终点

研究者

发起方
Elizabeth Kilbey
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elizabeth Kilbey

Consultant Clinical Psychologist

Child And Adult Neurodevelopment Assessment Ltd

研究点 (3)

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