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临床试验/ISRCTN18210449
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)

niversity of Birmingham0 个研究点目标入组 710 人开始时间: 2023年8月21日最近更新:

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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