ACTRN12623000259640招募中未知
A prospective cohort study to predict poor outcomes following mild traumatic brain injury
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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
- Observational
入排标准
- 年龄范围
- 14 Years 至 65 Years（—）
- 性别
- All
入选标准
- •i)Clinical diagnosis of concussion made by a medical practitioner
- •ii)Aged 14 – 65 years
- •iii)Able to be enrolled within 12 hours of head injury with symptoms attributable to that injury
- •iv)Post-Traumatic Amnesia of less than 24 hours
- •v)No significant findings on acute brain CT scan, or CT scan not required
- •vi)Willing and able to attend additional in-person assessment within 4 days of injury
排除标准
- •i)Glasgow Coma Scale <14 at the time of initial assessment
- •ii)Significant history of pre-existing conditions that would interfere with outcome assessment and follow-up (eg. Substance abuse/alcohol abuse, homelessness, terminal illness)
- •iii)Significant debilitating pre-existing diagnosed mental health disorder that would interfere with neuropsychological and possibly blood or saliva biomarker outcome measures or follow up (eg schizophrenia, bipolar disorder)
- •iv)Significant pre-existing neurological condition which may interfere with ability to complete outcome measures or follow up (eg. Stroke, dementia)
- •v)Pre-existing cognitive impairment such as intellectual disability which may interfere with ability to undertake neuropsychological examination
- •vi)Non-English speakers or poor English language skills which may interfere with ability to undertake neuropsychological examination
- •vii)Pregnant women
- •viii)Prisoners in custody or people known to be involved in illegal activity
- •ix)Deemed unlikely to comply with scheduled follow ups (e.g. homeless, alcohol dependence).
- •x)Head injury deemed to be entirely due to primary seizure.
- •xi)Significant other physical trauma that would interfere with physical and/or biochemical outcome assessments and follow up (eg lower limb injuries that would impede balance assessment, neck injuries that would restrict head movements, or cause changes in blood or saliva biomarkers)
- •xii)Epilepsy or history of seizures
- •xiii)Meets exclusion criteria to undertake MRI, which can be any of the following:
- •Has cardiac pacemaker or pacing wire in situ
- •Has metal surgical clips or staples of any kind (particularly aneurysm clips) in situ
- •Has had lap band surgery
- •Has electronic inner ear implants (bionic ears)
- •Has metal fragments in your eyes (past or present)
- •Has electronic stimulators
- •Has implanted pumps
- •Has metal pins or rods in bones
- •Has an IUCD (intrauterine contraceptive device) fitted
- •Has shrapnel, bullets or foreign bodies
研究者
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