Traumatic brain injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Participants will be sought to include into three study groups: a control group with no previous history of TBI or head injury
an acute TBI group who are recruited within 14 days after a head injury and a veteran group who have a diagnosis and head injury. Study participants must be over 18 years old, male or female, must hav
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute TBI group: 1. Over the age of 18 years 2. Must have two eyes 3. Capacity to consent 4. Willing and able to follow the protocol 5. Moderate or severe head injury requiring admission to the Queen Elizabeth Hospital within the prior 14 days Veterans with TBI group: 1. Over the age of 18 years 2. Must have two eyes 3. Capacity to consent 4. Willing and able to follow the protocol 5. Moderate or severe head injury requiring admission to a military hospital facility or service personnel with planned departure from the Armed Forces within 6 months Control group: 1. Over the age of 18 years 2. Must have two eyes 3. Capacity to consent 4. Willing and able to follow the protocol 5. No prior history of moderate or severe TBI
Exclusion criteria
Exclusion criteria: Exclusion criteria for all groups: 1. Patients under 18 years old 2. Patients registered as sight-impaired or severely sight-impaired 3. Any known prior pre-existing neuropsychiatric condition: dementia, epilepsy on neuro-epileptic drugs, Parkinson's disease, hereditary neurodegenerative conditions, any known retinal or optic nerve disorder of either eye, pregnancy Additional exclusion criteria for the control group only: Patients have not suffered a TBI or head injury
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Fluid biomarker levels in blood and saliva including neuronal damage (neurofilament light chain (NFL), neuron-specific enolase-1 (NSE1); tau, ubiquitin C-terminal hydrolase L1 (UCL-H1) and S100 beta) and immune markers (interleukin-6 (IL-6), tumor necrosis factor-alpha (TNFa) C reactive protein (CRP), brain-derived neurotrophic factor (BDNF), calcitonin gene-related peptide (CGRP) and pituitary adenylate-cyclase-activating polypeptide (PACAP) as well as hormones such as cortisol will be measured by enzyme-linked immunosorbent assays (ELISAs) on enrolment and at 6 and 12 months. 2. Visual function tests including optical coherence tomography, visual field, visual acuity, colour vision, contrast acuity, and pupil reactivity will be tested on enrolment and at 6 and 12 months 3. Mental health and quality of life outcomes assessed using patient-reported questionnaires at enrolment and at 3, 6, 9 and 12 months: 3.1. Social functioning measured using the social and occupational functioning assessment scale (SOFAS) 3.2. Visual impairment measured using the brain injury vision symptom survey (BIVSS) 3.3. Depression measured using the patient health questionnaire (PHQ9) 3.4. General anxiety disorder measured using the general anxiety disorder-7 (GAD-7) 3.5. Posttraumatic stress disorder measured using the PTSD checklist for DSM-5 (PCL-5) 3.6. Suicidal behaviour measured using the suicidal behaviour questionnaire revised (SBQ-R) 3.7. Alcohol use disorder measured using the alcohol use disorders identification test (AUDIT) 3.8. Quality of life measured using the EuroQoL Five-dimensional five-level questionnaire (EQ-5D-5L) | — |
Countries
England, United Kingdom
Contacts
Public ContactZubair Ahmed
Outcome results
None listed