Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001149651
Ethics application status
Approved
Date submitted
5/10/2023
Date registered
7/11/2023
Date last updated
16/11/2023
Date data sharing statement initially provided
7/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the utility of the BioEye application in identifying and monitoring concussion
Scientific title
A single-arm, Pivotal Study to determine the performance of screening ocularbiomarkers in participants with a concussion using the BioEye application
Secondary ID [1] 310741 0
BE 002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
concussion 331690 0
mild traumatic brain injury 331692 0
Condition category
Condition code
Injuries and Accidents 328428 328428 0 0
Other injuries and accidents
Neurological 328672 328672 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eye movements have been used for decades to interrogate neurological function, and we have an extensive understanding of the consequences of a broad range of neurological disorders on eye movements. BioEye is a smartphone application that uses artificial intelligence (AI), machine learning, and cloud based technology to record and anlayse the location of the eye in space over time, with a view to providing a snapshot of neurological function in an individual over time.

In patients diagnosed with concussion or a mild traumatic brain injury, the BioEye application will be used to record and measure (1) smooth pursuit eye movements (SMP) where a patient follows, with their eyes, a dot moving in a circle around the screen of their smartphone, and (2) the pupillary light reflex (PLR) where a patient looks at the back of the smartphone and the phone's own flash appears for 3 seconds to illuminate the eyes. These tests will take less than 5 minutes, including re-reading on-screen instructions if required.

Data will be collected at 4 timepoints: firstly within 24 hours of a post concussive event within the emergency department (ED) by an ED occupational therapist, and then 2, 7 and 30 days post event by the individual in his/her own home. Patients will be provided with SMS reminders to use the BioEye application on days 2, 7 and 30.

Data will include measures of latency, velocity, amplitude and accuracy for SMP and PLR.

From these data BioEye will determine a concussion algorithm that sensitively identifies and tracks recovery from concussion.
Intervention code [1] 327149 0
Diagnosis / Prognosis
Comparator / control treatment
Sensitivity and specificity will be determined by comparison with existing data in neurologically healthy individuals. These data have been collected in previous studies of healthy individuals over the past 12 months, specifically of studies conducted by Monash University researchers. These studies were granted approved by the Monash University Human Research Ethics Committee, as meeting the requirements of the National Statement on Ethical Conduct in Human Research.
Control group
Historical

Outcomes
Primary outcome [1] 336267 0
Sensitivity and specificity of an ocular marker algorithm derived from BioEye eye tracking data to identify and monitor recovery from a concussion (or mild traumatic brain injury: mTBI).
Timepoint [1] 336267 0
At end of trial.
Secondary outcome [1] 427620 0
Satisfaction and experience survey to inform future implementation in the hospital setting.
Timepoint [1] 427620 0
Upon completion of study (30 days post-concussive event)

Eligibility
Key inclusion criteria
• 200 individuals presenting to Gold coast University Hospital emergency Department (GCUH ED) within 24hours of a concussive event
• Age range of 14-60 years old
• Primary diagnosis of mild traumatic brain injury (mTBI) and related diagnostic groups as coded by Gold Coast Hospital Health Service Health Analytic Data including coded diagnostic groups of:
• Minor Head Injury
• Head Injury
• Concussion injury of cerebrum
• Concussion with loss of consciousness
• Concussion with no loss of consciousness
• Concussion with less than 1-hour loss of consciousness
• Seen by the ED Occupational Therapist for Diagnostic Interview of mild traumatic brain injury and clinical work-up with evidence of a clear ability to demonstrate new learning and recall using the Abbreviated Westmead Post Traumatic Amnesia Scale (aWPTAS)
• Score of 15/15 for at least one hour on the Glasgow Coma Scale (GCS)
• Access to smartphone capabilities for application use
Minimum age
14 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Co-occurrence of any other neurological condition
• Unable to communicate adequately based on informal clinical judgment by the ED Occupational Therapist regarding the participant’s ability to follow instructions needed to perform the test and understand the consent process
• Subjectively unable to see a 3mm object at a distance of 10 cm with one or both eyes, without eye-glasses
• Planned for an inpatient admission for mTBI symptom management from ED
• CT Brain or MRI that demonstrates intracranial pathology or injury e.g., skull fracture, extra dural haematoma (including suspected), orbital floor injuries/blow out
• Concurrent injuries receiving an inpatient admission e.g., motor vehicle accident or sporting injury requiring surgery
• Admittance to an accessory site constructed in periods of medical response e.g., Mobile ED services provided at Schoolies formal events
• Residing in a Residential Aged Care Facility or supported living facility e.g., NDIS supported accommodation, group home
• Residing outside of GCHHS catchment area
• No access to smartphone capabilities for application use

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical methods will align with the development of a commercially viable algorithm suitable for identifying change in neurological function. Standard methods will variously include score adjustment for extraneous factors, normalisation/standardisation of scores, principal components analyses, and regression analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25703 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 41527 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 314972 0
Commercial sector/Industry
Name [1] 314972 0
BioEye Pty Ltd
Country [1] 314972 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BioEye Pty Ltd
Address
The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country
Australia
Secondary sponsor category [1] 316975 0
None
Name [1] 316975 0
Address [1] 316975 0
Country [1] 316975 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313946 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 313946 0
1 Hospital Blvd, Southport, QLD, 4215
Ethics committee country [1] 313946 0
Australia
Date submitted for ethics approval [1] 313946 0
11/10/2023
Approval date [1] 313946 0
09/11/2023
Ethics approval number [1] 313946 0
HREC/2023/QGC/100898

Summary
Brief summary
Eye movements have been used for decades to interrogate neurological function, and we have an extensive understanding of the consequences of a broad range of neurological disorders on eye movements. BioEye is a smartphone application that uses AI, machine learning, and cloud based technology to record and anlayse the location of the eye in space over time, with a view to providing a snapshot of neurological function in an individual over time.

In patients diagnosed with concussion or a mild traumatic brain injury, the BioEye application will be used to record and measure smooth pursuit eye movements (SMP) and the pupillary light reflex (PLR) as an indication of brain function.

Data will be collected at 4 timepoints: firstly within 24 hours of a post concussive event within the emergency department (ED) by an ED occupational therapist, and then 2, 7 and 30 days post event by the individual in his/her own home.

Data will include measures of latency, velocity, amplitude and accuracy for both SMP and PLR.

From these data BioEye will determine a concussion algorithm that sensitively identifies and tracks recovery from concussion.

We hypothesise that this algorithm will sensitively identify an individual with (a diagnosed) concussion and may assist in monitoring recovery .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129882 0
A/Prof Joanne Fielding
Address 129882 0
BioEye Pty Ltd, The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country 129882 0
Australia
Phone 129882 0
+61 414883541
Fax 129882 0
Email 129882 0
joanne.fielding@bioeye.com
Contact person for public queries
Name 129883 0
A/Prof Joanne Fielding
Address 129883 0
BioEye Pty Ltd, The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country 129883 0
Australia
Phone 129883 0
+61 414883541
Fax 129883 0
Email 129883 0
joanne.fielding@bioeye.com
Contact person for scientific queries
Name 129884 0
A/Prof Joanne Fielding
Address 129884 0
BioEye Pty Ltd, The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country 129884 0
Australia
Phone 129884 0
+61 414883541
Fax 129884 0
Email 129884 0
joanne.fielding@bioeye.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is commercially sensitive i.e., used for the development/refinement of a commercial product.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20608Study protocol    Not available yet



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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