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Clinical Trials/ISRCTN18210449
ISRCTN18210449
Active, not recruiting
未知

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 sites710 target enrollmentAugust 21, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Birmingham
Enrollment
710
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 21, 2023
End Date
November 30, 2029
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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:

Outcomes

Primary Outcomes

Not specified

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