ACTRN12619001226190招募中未知
A validation 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
- 500
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
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •i) Clinical diagnosis of concussion made by a medical practitioner
- •ii) Able to be recruited within 7 days of head injury with symptoms attributable to that injury
- •iii) Post-Traumatic Amnesia of less than 24 hours
- •iv) No significant findings on acute brain CT scan, or CT scan not required
排除标准
- •All participants will complete Phase I. Eligible participants that have completed Phase I will complete Phase II, up to a maximum of 120 participants.
- •Phase I Exclusion Criteria:
- •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 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 28-day follow up e.g. homeless, alcohol dependence.
- •x) Head injury deemed to be entirely due to primary seizure.
- •Phase II Exclusion Criteria:
- •i) Significant other physical trauma that would interfere with physical and/or biochemical outcome assessments and follow up (eg lower limb injuries that would compromise balance or exercise bike testing, or cause changes in blood biomarkers)
- •ii) Any pre-existing heart conditions that may compromise ability to complete an exercise tolerance test
- •iii) Epilepsy or history of seizure
- •iv) 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
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