Mild traumatic brain injury biomarker study, a prospective cohort biomarker study of military and civilian participants with mild traumatic brain injury

Not Applicable

• Conditions: Mild traumatic brain injury; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN18210449
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-21
• Last Update Posted: 18 September 2023
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 710

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:
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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ability of candidate biomarkers to predict full return to play, work or duty at 6 months post-injury, measured using:<br>1. Headache: patient-completed headache diary<br>2. Mental Health: Post-Traumatic Stress Disorder checklist<br>3. Vestibular: vestibular perceptual thresholds<br>4. Cognition: Corrected Global Composite Score<br>5. Visual: retinal nerve fibre layer thickness<br>6. Imaging: MRI, magnetoencephalography (MEG)<br>7. Hormone/biofluids: cortisol, glial fibrillary acidic protein<br>8. Cerebral physiology: cerebrovascular reactivity, physical function tests

Secondary Outcome Measures

Name	Time	Method
The ability of candidate biomarkers to predict global function, persistent post-traumatic headache, cognitive dysfunction, depression, PTSD, vestibular disturbances and physical function at 6 months, measured using:<br>1. Headache: patient-completed headache diary<br>2. Mental Health: Post-Traumatic Stress Disorder checklist<br>3. Vestibular: vestibular perceptual thresholds<br>4. Cognition: Corrected Global Composite Score<br>5. Visual: retinal nerve fibre layer thickness<br>6. Imaging: MRI, magnetoencephalography (MEG)<br>7. Hormone/biofluids: cortisol, glial fibrillary acidic protein<br>8. Cerebral physiology: cerebrovascular reactivity, physical function tests<br><br>Exploratory outcomes:<br>Accuracy of a multifaceted computer-modelled biomarker algorithm to predict sequelae of mTBI (full return to play, work or duty, persistent post-traumatic headache, cognitive dysfunction, depression, PTSD, vestibular disturbances, and physical function) using computer modelling at 6 months post-injury<br>