The Mission of the Neurotrauma and Psychological Health (NPH) Project Management Office is to rapidly develop and field Food and Drug Administration (FDA) approved medical solutions across the continuum of care. These are solutions that aid in the detection, protection, prevention and treatment of neurotrauma/head injury and psychological health conditions, such as Traumatic Brain Injury (TBI), Post-Traumatic Stress Disorder and suicide. This program enables warfighter health, readiness and lethality. The portfolio consists of:
Laboratory Assays for TBI (LATBI)
This is a blood test to screen an injured service member for mild TBI. The test detects the presence of proteins in the blood as the result of brain injury. Initially, this test will be used as a point of care triage tool to determine if the service member requires the more definitive Computerized Tomography (CT) scan. Follow-on development/increments will be aimed at providing a stand-alone aid in the diagnosis of TBI.
Noninvasive Neuro-Assessment Devices (NINAD)
The development effort supports a device to provide reliable and accurate diagnosis of TBI.
- Increment I – Handheld device to screen service members for head injuries by scanning the outside of the head. These technologies will provide a non-invasive, rapid method to determine the need for a CT scan. In concert with the Rapid Equipping Force, units have been equipped with two FDA-cleared devices to support current
- Increment II – Technologies that can be used in conjunction with the LATBI to provide clinicians a broad spectrum of capabilities for diagnosing brain injury. These technologies include, but are not limited to, eye tracking and brain blood flow motion tracking.
BENEFIT TO THE SOLDIER
TBI results in a variety of physical, cognitive, social, emotional and behavioral effects with outcomes ranging from complete recovery to permanent disability or death. Based on data from the past five years, the Department of Defense can expect to diagnose 20,000-25,000 cases of TBI per year across theater and garrison settings worldwide, regardless if deployed or not. However, TBI diagnosis still relies on self-report of the injury and incident. Early identification of TBI injuries will reduce lost duty time and prevent complications that may impact a service member’s performance; therefore, keeping the Soldier in the fight, and improving their lethality.
System attributes established in the requirements documentation that include FDA licensure
FY16-FY18: Products are in varying stages of completion and undergoing Development Test/Operational Test
FY19-FY23: Human studies will be conducted for these devices to receive FDA clearance