DoD Complex Traumatic Brain Injury Rehabilitation Research - Clinical Trial Award | W81XWH 19 CTRR CTA

Opportunity Information: Apply for W81XWH 19 CTRR CTA

The DoD Complex Traumatic Brain Injury Rehabilitation Research - Clinical Trial Award (FY19 PH/TBIRP CTRR-CTA) is a Department of Defense funding opportunity intended to speed up the launch and execution of clinical trials that could materially improve how complex traumatic brain injury (TBI) is treated or managed. The emphasis is on practical, patient-focused studies that can move an intervention forward in a way that meaningfully affects clinical care, particularly for populations connected to military service. The administering organization is the Department of Defense, Department of the Army, US Army Medical Research Acquisition Activity (USAMRAA), and the opportunity was posted under funding opportunity number W81XWH 19 CTRR CTA within the broader category of science and technology research and development (CFDA 12.420).

At its core, this award is specifically designed to support clinical trials, meaning the proposed project must involve prospective assignment of one or more human participants to one or more interventions (including, when appropriate, placebo or other control conditions) in order to measure effects on biomedical or behavioral health related outcomes. In other words, this mechanism is not meant for basic science, retrospective analyses, or purely observational work; it is meant for trials that actually test an intervention in people. The program description points applicants to additional human subjects guidance through a Human Subject Resource Document available via eBRAP, reinforcing that applicants should be prepared for the regulatory, ethical, and operational requirements that come with trial conduct.

The scientific focus is complex TBI in a rehabilitation and recovery context, with an emphasis on the kinds of complicated, multi-domain problems that can follow mild TBI when it occurs alongside other conditions and produces overlapping deficits. The opportunity describes TBI broadly as resulting from a direct blow or impact to the head, a penetrating head injury, or exposure to external forces such as blast waves that disrupt brain function. It also clarifies that not every head impact or blast exposure results in TBI, and it notes the typical severity spectrum from mild (brief alteration in mental status or consciousness) to severe (extended unconsciousness or prolonged confusion). For defining and classifying severity, it references the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury, specifically pointing to the table that lays out severity criteria. The term "complex TBI" is framed as a multi-faceted condition that can arise after mild TBI in combination with comorbidities, with deficits that may span cognition, sensorimotor functioning, and performance, which is consistent with the real-world rehabilitation challenge of treating patients whose symptoms and impairments do not fit neatly into a single domain.

In terms of what can be tested, the program is intentionally broad and translational. Supported trials may evaluate promising products, pharmacologic agents (including drugs and biologics), medical devices, clinical guidance or care pathways, and emerging approaches or technologies. This flexibility allows applicants to propose anything from a tangible therapeutic to a structured clinical management strategy, as long as it is tested through a properly designed clinical trial. The mechanism is positioned to accommodate a wide range of trial maturity, from smaller proof-of-concept studies such as pilot trials, first-in-human work, or Phase 0 style feasibility efforts, all the way up to larger trials aimed at determining efficacy in relevant patient populations. The common thread is the intent to rapidly implement trials that could have a significant impact, so proposals are expected to be ready to move and to be designed in a way that can credibly inform clinical practice or the next stage of development.

The relevance requirement is also explicit: proposed research must be pertinent to active duty Service members, Veterans, military beneficiaries, and/or the American public. While the military relevance is central given the program sponsor, the inclusion of the broader public signals that the DoD is interested in benefits that extend beyond strictly military treatment settings, especially because many TBI rehabilitation advances are broadly applicable to civilian care.

From an administrative standpoint, the opportunity is categorized as discretionary funding, and awards may be made as either cooperative agreements or grants, depending on the level of federal involvement anticipated during performance. Eligibility is listed as unrestricted, meaning any type of entity may apply, subject to any additional eligibility details that may be provided in the full announcement. The posting indicates an expected number of awards of two, and it lists the award ceiling as 0, which typically signals that applicants should consult the full announcement for budget constraints or that a fixed maximum was not stated in that summary field. The opportunity was created on July 22, 2019, with an original closing date of December 2, 2019, which places it in the FY19 cycle for the Psychological Health and Traumatic Brain Injury Research Program (PH/TBIRP) and this specific Complex Traumatic Brain Injury Rehabilitation Research (CTRR) clinical trial mechanism.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Complex Traumatic Brain Injury Rehabilitation Research - Clinical Trial Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Jul 22, 2019.
• Applicants must submit their applications by Dec 02, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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