Mild traumatic brain injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The 610 mTBI participants will have in-person assessments (clinical and imaging) at baseline (both 21 days and 3 months after mTBI), with remote follow-up continuing until 2 years after mTBI. 40 mTBI
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ability of candidate biomarkers to predict full return to play, work or duty at 6 months post-injury, measured using: 1. Headache: patient-completed headache diary 2. Mental Health: Post-Traumatic Stress Disorder checklist 3. Vestibular: vestibular perceptual thresholds 4. Cognition: Corrected Global Composite Score 5. Visual: retinal nerve fibre layer thickness 6. Imaging: MRI, magnetoencephalography (MEG) 7. Hormone/biofluids: cortisol, glial fibrillary acidic protein 8. Cerebral physiology: cerebrovascular reactivity, physical function tests | — |
Secondary
| Measure | Time frame |
|---|---|
| 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: 1. Headache: patient-completed headache diary 2. Mental Health: Post-Traumatic Stress Disorder checklist 3. Vestibular: vestibular perceptual thresholds 4. Cognition: Corrected Global Composite Score 5. Visual: retinal nerve fibre layer thickness 6. Imaging: MRI, magnetoencephalography (MEG) 7. Hormone/biofluids: cortisol, glial fibrillary acidic protein 8. Cerebral physiology: cerebrovascular reactivity, physical function tests Exploratory outcomes: 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactAndrew Palmer
Outcome results
None listed