ACTRN12623001149651尚未招募Unknown
A single-arm, Pivotal Study to determine the performance of screening ocularbiomarkers in participants with a concussion using the BioEye application
BioEye Pty Ltd0 个研究点目标入组 200 人开始时间: 2023年11月7日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 14 Years 至 60 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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