DHA26BZ01-NV002 — Detection and Treatment of Traumatic Brain Injury in Military Working Dogs

Award Maximum: $300,000 Period of Performance: 6 months Phase Type: Phase I

OBJECTIVE: Evaluate previously developed traumatic brain injury (TBI) detection and treatments methods that can be repurposed for use in military working dogs (MWDs) after suffering from battlefield injuries.

DESCRIPTION: This topic is in support of the DoD Working Dog Strategic Research Plan concerning mitigation, strategies, and treatments for the detection and treatment of TBI. Due to the high-risk nature of MWD operations, TBI is a common injury. TBI in the MWD carries an extremely high mortality rate with a prehospital mortality of over 40% for severe TBI cases. It is estimated that 25-40% of all MWD trauma cases are accompanied by TBI, but there is limited data concerning the short- and long-term effects of TBI on the performance and health of the MWD. Current clinical detection methods for TBI in the MWD are by the observation of altered mentation (coma, stupor, depression, lethargy, inappropriate behavior or responses) of the MWD and by use of the modified veterinary Glasgow coma scale or with physical evidence of head trauma (e.g., lacerations, abrasions, bruising, swelling, pain, bleeding from the nose or ears). Current treatment guidelines for TBI in MWDs are largely based on treatment recommendations for humans and are primarily supportive measures to maintain blood pressure, oxygen levels, proper ventilation, and body temperature to mitigate secondary injuries. There have been many TBI detection methods and treatment strategies developed for humans that have shown promising results in rodent and large animal models. The objective of this SBIR is to review research that was performed in rodents, canines, or other large animal models that could be repurposed for the detection and treatment of TBI specifically in MWDs. This research topic does not support the use of canines for testing purposes. Any animal testing would require use of suitable animal model that would approximate the response of a canine.

PHASE I: Identify TBI detection and/or TBI treatment methodologies that could be used for canine physiology based on previous TBI research. Develop a solution that builds on one or more of these methodologies. This solution must address the level(s) of TBI severity (mild, moderate, and severe) that the detection or treatment solution will address. Determine the technical feasibility of performing the proposed TBI detection and/or treatment concept in a Role 1 or Role 2 setting within a 72-hour window post injury. Define key components and milestones needed to develop the proposed solution. Develop a research plan that can be used to conduct in vitro and/or in vivo feasibility studies. This plan must include study descriptions and methods for determining study endpoints which will be used to measure the effectiveness of the detection or treatment methodology. The developed plan must also address any potential risks that may occur as part of any in vivo studies. The size of any studies performed must be appropriately powered to ensure that the results are statistically significant. Any in vivo studies are to be planned using a suitable animal model that approximates the canine. No canine research will be performed for this topic area. The plan must include the descriptions and methods of determining the study endpoints to be measured for successful prototypes. The expectation is that the outcome of this phase will be a developed plan for prototype development and for proof-of-concept testing.

PHASE II: Develop a working TBI detection prototype and/or TBI treatment based on the solution outlined in Phase I that can be used for laboratory feasibility testing. Conduct the feasibility studies as described in the outcome documentation of the Phase I project to demonstrate the feasibility of the prototype and document the results which can be used to determine success in an appropriate in vivo model. No canine research will be performed for this topic area. The testing plan as described in Phase I for any in vivo study must compare the proposed solution to current TBI detection methods (altered mentation criteria and/or veterinary Glasgow coma scale) or TBI treatment methods (as defined by the Management Algorithm for TBI for MWDs) as a base measure of effectiveness. Additional outcome measures based on the method to test can include detection time, detection rate, rate of survival, permanent behavioral changes, ability to return to duty, and/or days until return to duty. Successful prototype solutions must develop final product specification documents that list all product components and their concentrations, instructions for storage, and instructions for preparation (if required) and use. Develop an initial plan for product approval through the appropriate regulatory pathway of the FDA Center for Veterinary Medicine (CVM).

PHASE III DUAL USE APPLICATIONS: The end goal is to achieve FDA CVM approval for the prototype developed in Phase II. Optimize the TBI detection prototype and/or the TBI treatment and demonstrate its usefulness with end users. Use feedback from end-users to further optimize the prototypes. Transition the prototype from an advanced development stage to a fully vetted product ready for real-world use. Refine the development of a commercialization plan that may include development of different pathways, including both military and private sectors. This product should be applicable to a broad spectrum of civilian use markets, including emergency veterinary facilities, other government agencies (DHS, FEMA, ATF, etc.), law enforcement and search and rescue canines. In addition, the work may result in technology transition to Acquisition Program managers within DoW. These efforts will be crucial in turning the prototype into a commercially viable product that can be rapidly deployed in military operations.