ISRCTN18210449进行中(未招募)Unknown
Mild traumatic brain injury biomarker study, a prospective cohort biomarker study of military and civilian participants with mild traumatic brain injury (mTBI-Predict)
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 入组人数
- 710
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
- 性别
- All
入选标准
- •Main study:
- •1. Aged =18 and =60 years
- •2. mTBI: acute (<3 months) mild traumatic brain injury (as per VA/DoD criteria)
- •Healthy controls:
- •1. Aged =18 years and =60 years
- •2. Healthy (screened through NHS General Health Questionnaire)
排除标准
- •Main study:
- •1. Prior diagnosis of PTSD or severe mental illness (e.g. bipolar disorder or psychosis)
- •2. Pregnancy
- •3. Prior brain injury (from trauma, stroke or other aetiologies) without full functional and symptomatic recovery
- •4. Inability to comply with study schedule or follow-up
- •5. Inability to provide informed consent (e.g. due to cognitive impairment)
- •6. Any progressive neurodegenerative or neuroinflammatory condition
- •7. Alcohol use disorder or drug dependence
- •8. Patients with medical conditions that are unstable or untreated
- •Healthy controls:
- •1. Medical condition requiring treatment or significant past medical history
- •2. Prior diagnosis of PTSD or severe mental illness
- •3. Pregnancy
- •4. Prior brain injury (from trauma, stroke or other aetiologies) without full functional and symptomatic recovery
- •5. Inability to comply with study schedule or follow-up
- •6. Inability to provide informed consent (e.g. due to cognitive impairment)
- •7. Inability to safely enter the MRI environment (for imaging variability and case-control study)
- •8. Any progressive neurodegenerative or neuroinflammatory condition
- •9. Cardiovascular or cerebrovascular disease or hypertension (no current diagnosis/medication)
- •10. Alcohol use disorder or drug dependence
- •11. Patients with medical conditions that are unstable or untreated
- •12. History of pituitary hormone deficits
研究者
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