The TRACK-TBI Biomarker Project NF-L (TRACK-TBI BIO NF-L) will extend the follow-up periods for TRACK-TBI participants from 1 to 5 years. The extensive clinical, imaging, and biomarker data that has already been collected in these subjects will allow for the identification of risk factors, co-morbidities, and prognostic biomarkers of TBI. Consequently, the extension of study follow-up will help to determine negative neurological and psychological outcomes of individuals who experienced a TBI compared to healthy controls. A secondary objective of this study is to validate serum NF-L as a biomarker of traumatic axonal injury, and through this project obtain data that will allow us, at the end of the 5-year project period, to submit a Qualification Plan to the Center for Drug Evaluation and Research at FDA for qualification of serum- NF-L as a Drug Development Tool.
If you are interested in learning more about this study, please see the study on Clinicaltrials.gov