About the study
Mild Traumatic Brain Injury Biomarker Study, a prospective cohort biomarker study of military and civilian participants with mTBI.
What is this research for?
- Mild traumatic brain injury (or mTBI), commonly called concussion
- We don’t always know how a mild traumatic brain injury will affect people’s health
- This study will test members of the public, service personnel and sports people to find ways to help us predict how a brain injury will affect people’s health
- This will help us treat people better, getting them back to work, duty or play quicker
Locations
Information about the Study
Study Design
Longitudinal prospective cohort study with nested variability and case-control studies in military and civilian populations including impact, blast and sports injury.
Main study inclusion criteria
Age ≥18 & ≤60 years
mTBI: Acute (<3 months) mild traumatic brain injury
Study Funders
This project is funded by the United States Department of Defense and the UK Ministry of Defence. The University of Birmingham is the study sponsor.
Main study
Longitudinal prospective cohort study
610 participants will undergo assessments of candidate biomarkers. Prognostic outcome assessments will follow at 6, 12 and 24 months with long term digital follow-up. A prospective cohort design allows us to observe the development and resolution of symptoms in real-time. By including all new injuries where possible, we will minimise selection bias and symptom recall error.
Nested study 1
Candidate biomarker variability study
Biomarkers will be repeated over 12 days in 40 mTBI patients and 40 healthy controls. Understanding the variability of biomarkers is critical to later using them in a predictive model; this study will allow us to collect this vital data.
Nested study 2
Observational case-control prospective study
100 cases of mTBI will be compared to 100 healthy controls to identify novel biomarkers. Identifying new biomarkers in someone with mTBI and a healthy control will allow us to track changes in these biomarkers over the course of recovery. We should get a reliable measure of ‘normal’ variability in outcomes across the course of the study.