Assessing the utility of the BioEye application in identifying and monitoring concussio
- Conditions
- concussionmild traumatic brain injuryInjuries and Accidents - Other injuries and accidentsNeurological - Other neurological disorders
- Registration Number
- ACTRN12623001149651
- Lead Sponsor
- BioEye Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 200
•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
•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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). [Algorithm developed from latency, velocity, amplitude, and accuracy data that derive direclty from BioEye application measurments. At end of trial.]
- Secondary Outcome Measures
Name Time Method Satisfaction and experience survey to inform future implementation in the hospital setting. [Satisfaction rating scale. This will be developed specificaly for this study and will comprise items addressing the useability of the BioEye application with responses presented on a 5 point likert scale (strongly disagree, disagree, neutral, agree, strongly agree) Upon completion of study (30 days post-concussive event)]