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Assessing the utility of BrainEye eye-tracking technology in managing neurological conditions

A single-arm, Pivotal Study to determine safety, usability and performance ofscreening ocular biomarkers in participants with a neurological condition using the BrainEye application

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001151628
Enrollment
224
Registered
2023-11-07
Start date
2024-02-09
Completion date
2025-03-18
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Neurological disorders are the leading cause of disability world-wide. Due to our aging population and population growth, this burden will inevitably increase over time. To add to this burden, our capacity to detect and treat many neurological disorders is hampered not only by gaps in our knowledge but by a lack of appropriate and cost-effective biomarkers to measure and monitor change in function. The study of eye movements is an established and widely used methodology in experimental research, the assessment of eye movements already an integral part of the clinical examination with distinctive eye movements characteristic of almost all neurological conditions. However, eye movements cannot currently be measured with precision outside of the research setting. This research aims to establish the utility of the BrainEye eyetracking application in measuring aberrant function in some of the most common neurological diseases. By measuring simple eye movement parameters in patients with various neurologic conditions we will ascertain WHETHER the application can be used by the individual to self monitor change or by a physician to monitor change in function and adjust or implement treatments at the earliest possible timepoint.

Interventions

Neurological disorders are the leading cause of disability world-wide. Due to our aging population and population growth, this burden will inevitably increase over time. To add to this burden, our capacity to detect and treat many neurological disorders is hampered not only by gaps in our knowledge but by a lack of appropriate and cost-effective biomarkers to measure and monitor change in function. The study of eye movements is an established and widely used methodology in experimental research,

Neurological disorders are the leading cause of disability world-wide. Due to our aging population and population growth, this burden will inevitably increase over time. To add to this burden, our capacity to detect and treat many neurological disorders is hampered not only by gaps in our knowledge but by a lack of appropriate and cost-effective biomarkers to measure and monitor change in function. The study of eye movements is an established and widely used methodology in experimental research, the assessment of eye movements already an integral part of the clinical examination with distinctive eye movements characteristic of almost all neurological conditions. However, eye movements cannot currently be measured with precision outside of the research setting. This research aims to establish the utility of the BrainEye eyetracking application in measuring aberrant function in some of the most common neurological diseases. By measuring simple eye movement parameters in patients with various neurological conditions we will ascertain whether the application can be used to dissociate individuals with a neurological condition from individuals without a neurological condition (specifically, by using smooth pursuit and pupillary light reflex ocular markers). Beyond this study, this may help to determine whether the BrainEye applcation can provide a safe and simple measure of change in neurological function over time. The researchers will test all participants once, within their neurology clinic at the Alfred Hospital using the BrainEye application on a (Neuro Optica owned) smartphone. To measure smooth pursuit eye movements participants will be asked to follow a dot moving in a circle across the screen of the smartphone. To measure the pupillary light reflex, the BrainEye application will use the smartphone flash to illuminate the participants eyes for 3 seconds. Testings sessions will take no longer than 5 minutes (including delivery of instructions).

Sponsors

Neuro Optica Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

• Diagnosis of a medical condition directly impacting the integrity of the Central Nervous System (patients only) • No evidence of a medical condition directly impacting the integrity of the Central Nervous System (healthy individuals only) • Aged 18 years or over • Eligible to receive Medicare

Exclusion criteria

• Co-occurrence of more than one neurological condition (patients only) • Any neurological condition (healthy individuals only) • Unable to communicate adequately for whatever reason based on informal clinical judgment by the clinical staff member regarding the patient’s ability to follow instructions needed to perform the test and understand the consent process (patients only). • Subjectively unable to see a 3mm object at a distance of 10 cm

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026