Sport concussion Injury, Occupational Diseases, Poisoning Concussion
Conditions
Interventions
Consented non-concussed athletes will participate in a baseline screening consisting of same tests as for the concussed players, although these may not include Magnetic Resonance Imaging (MRI) screeni
a blood sample may be obtained from consented non-concussed athletes shortly after. These samples will be considered as part of the baseline screening and used as control data of the biomarkers level.
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female athletes participating in sports which involve physical contacts between players through our recruitment contacts in University Sports 2. Male or female patients who have been diagnosed with concussion 3. Individuals aged 16-65 years, with fluent English speaking 4. Single or double mTBI as outlined above less than 72 hours prior to assessment 5. Normal neurological objective examination at the time of enrolment
Exclusion criteria
Exclusion criteria: 1. Individuals who require hospital admission after initial assessment for their TBI 2. Intracranial blood, brain tissue injury, or non-TBI related pathologies on initial CT/MR scan 3. Pregnancy (urine pregnancy test will be performed for confirmation) 4. Any history of neurodegenerative pathology or any recent or ongoing illness affecting the central nervous system (e.g. Parkinson’s, multiple sclerosis, meningitis, epilepsy, neoplasm) 5. History of chronic alcohol or drug abuse 6. Any other sustained injury that requires hospital admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Saliva and urine biomarkers measured by metabolomic and genomic analysis of samples collected pre-season and at various time points after concussion 2. In addition, some athletes complete a battery of neurophysiological tests (ImPACT, WAIS-IV, MSVT), balance assessments, MRI (1H-MRS, fMRI, MRE, DTI) and blood sampling at 48-72h after injury All primary analyses will be made according to the matched groups (concussion, uninjured controls and orthopaedic controls). The primary comparison will focus on differential biomarker levels between concussed players and uninjured post-game controls. Unless otherwise specified, estimates of differences between groups will be presented with 95%, two-sided confidence intervals. P-values will be reported from two-sided tests at the 5% significance level. The primary results will be reported after all matches in the 2017-2018 season have been completed and all samples have been collected and processed for biomarker analysis. Further analyses will conducted in future seasons. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed