US Department of Defense
BLAST INJURY RESEARCH
COORDINATING OFFICE
Advancing Blast Injury Research to Protect and Heal Those Who Serve

Development of Clinical Sub-types to Categorize Traumatic Brain Injury Patients in Clinical Trials

On December 16, 2016, the Brain Health Research Program Coordinator, COL Sidney Hinds II, was invited to participate in a meeting to discuss concussion sub-types hosted by the Brain Trauma Foundation (BTF) and the University of Pittsburgh Medical Center (UPMC) in Dallas-Fort Worth, Texas. The goal of the meeting was to establish and utilize clinical concussion sub-types in order to more accurately stratify patient populations that are used to evaluate concussion diagnostics and therapeutics. These efforts were prompted by the disappointing outcomes of past clinical trials in mild traumatic brain injury (mTBI) that likely failed because patient populations were generally assumed homogenous and did not take into account the clinical heterogeneity of the concussed patients. UPMC has devised a clinical concussion sub-type grouping, which includes posttraumatic headache, mood and anxiety, cognitive, vestibular, ocular, and sleep sub-types.

In the coming months, the concussion sub-types working group, in collaboration with additional subject matter experts, will continue to investigate these sub-types, and make recommendations for inclusion and exclusion criteria for clinical research studies. The working group plans to publish these evidence-based recommendations in a peer-reviewed journal. Understanding and utilizing a classification system of this nature will facilitate more accurate clinical trials in mTBI in the future, especially in the current absence of objective concussion biomarkers. In addition, this work will be instrumental in providing guidelines for future research and program announcements made by the Joint Program Committees and the Program Area Directorates.

Last modified: 18-Jun-2019