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RFI: Noninvasive mTBI Tool
The Uniformed Services University of the Health Sciences (USU) is the leadership academy for military medicine and a research and development institution for the Department of Defense medical research program. As part of its mission, USU is charged to catalyze scientific collaboration among military and civilian investigators that results in the development and translation of knowledge and materiel products aligned with Military Health System (MHS) and Department of Defense (DoD) requirements.
Developing new methods and technologies to improve the diagnosis and management of mild traumatic brain injury (mTBI), otherwise known as concussion, is a high priority for the MHS. The USU TBI Research Consortium (TBIRC) coordinates multiple lines of effort in this clinical area. The USU TBIRC is composed of several leading research groups involved in the conduct of clinical studies on all severities of TBI (mild, moderate and severe). USU is seeking information related to planned or ongoing clinical trial research projects on non-invasive assessment technologies designed for the detection and management of mTBI.
USU is issuing this Request for Information (RFI) to survey available and/or emerging technologies that have the potential to address the following areas of interest in the detection and management of mTBI:
1) Utility of the non-invasive technologies, individually or in combination, as initial diagnostic and/or screening tool(s) for individuals who have been exposed to events associated with mTBI (i.e. individuals who have been exposed to scenarios associated with a risk of mTBI, but in whom the diagnosis has not yet been made). The technology or technologies should be compared against current standard(s) of care.
2) Ability of available and/or emerging biomedical non-invasive technologies, individually or in combination, to provide prognostic information that can among other things, predict return to activity/duty time for those who have been diagnosed with concussion/mTBI when compared to current standard(s) of care/return to activity protocols.
3) Utility of the non-invasive technologies, individually or in combination, to serve as tools by which inclusion and or exclusion criteria can be determined for entry of individuals into clinical studies of candidate therapeutics in the management of mTBI. Comparative assessment of the technology or technologies should be against current clinical standards (treatment of functional deficits and symptoms related to mTBI will be prioritized).
Response Date: 27 Jul 2020