Candidate Acute Traumatic Brain Injury (TBI) Management Capabilities (CATMC) and Acute TBI Diagnostics and Monitoring (ATDM) in Austere Environments
Current wartime operations assume that the United States and our allies will maintain air, land, maritime, space and cyber superiority. Future conflicts against peer and near-peer adversaries are expected to be layered stand-offs, fought across multiple domains (Multi-Domain Operations, MDO). Mission success will be determined by our ability to compete to expand the competitive space, penetrate both strategic and operationally, disintegrate enemy’s defenses, exploit enemy weaknesses and re-compete to consolidate gains. Medical plays a critical role in each aspect of MDO and must modernize rapidly to maintain Force readiness and increase soldier lethality. Diagnosis, treatment, monitoring, and maintenance of TBI casualties in the acute setting can significantly improve long-term functional outcomes and reduce injury severity. Development of diagnosis and treatment interventions to reduce injury severity and improve casualty maintenance that can be employed at Role 1 (far-forward medical care), over the course of the subsequent 1-3 days following injury, will facilitate reductions in permanent brain damage, better Warfighter care and improved return-to-duty times.
Traumatic brain injury (TBI) is a major health burden in both military and civilian populations. In the last two decades, there have been approximately 420,000 documented incidents of Service members sustaining at least one TBI. Future combat operations are expected to result in an increase in time to evacuation, delaying TBI diagnosis and treatment during the most critical period after injury. This MTEC program is aimed at acute diagnostic, therapeutic and management technologies across the spectrum of TBI severities capable of being used in a far-forward operational environment with a specific focus on treatments and diagnostics as described below:
- • FOCUS AREA #1 (Treatments): Development of a treatment (pharmaceutical, technological, etc.) for traumatic brain injury.
Despite the enormous burden of TBI on Service members and their family, there is no effective FDA-approved therapeutic intervention. In addition to the complexities of treating TBI, future operational environments pose an addition barrier to the treatment of TBI: time and location. Therefore, the intent of this focus area is to enable the advancement of candidate treatments (pharmaceutical, technological, etc.) applicable to the far forward environment through Phase I clinical trials for the treatment of TBI.
- • FOCUS AREA #2 (Diagnostics): Diagnostic, prognostic and management technologies for TBI, most likely requiring FDA clearance.
Currently, TBI severity is stratified by Glasgow Coma Scale (GSC)- mild (GCS 14-15), moderate (GCS 9- 13), and severe (GCS 3-8); however, a more thorough classification of TBI based on endophenotypic characterization of the injury (neurological exam, imaging, blood-based biomarkers, symptomology, etc.) would provide a more comprehensive picture of the overall injury burden. Additionally, in future combat operations, delayed evacuation times will create a prolonged care scenario that will require TBI casualty management for periods in excess of 24 hours. Therefore, the intent of this focus area is to enable the advancement of candidate technologies for the objective diagnosis, prognosis, and/or management of TBI. Project proposals are currently under evaluation. The research project award recipients will be selected from the Offerors who responded to MTEC’s Request for Project Proposals (MTEC 20-15-TBI).