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Development (or Application) of a Non-Invasive Device to Measure Changes in Intra-Cranial Pressure resulting from Viral or Bacterial Infections of the Central Nervous System

Description:

TECHNOLOGY AREA(S): Chem Bio_defensebio Medical 

OBJECTIVE: Innovate a portable/handheld non-invasive device to measure intracranial pressure (ICP) to support development of medical countermeasures. 

DESCRIPTION: As stated in the President’s National Biodefense Strategy for 2018, “a collaborative, multi-sectoral, and trans-disciplinary approach” is necessary for a robust biodefense enterprise. Therefore, development of advanced diagnostics and/or triage capabilities for infected individuals ideally should occur concomitantly with the development of medical countermeasures (MCMs). This topic seeks to develop a novel device for non-invasive monitoring of intracranial pressure (ICP). ICP measurement has been used for diagnosis of traumatic brain injury (TBI), and a similar need exists for measuring ICP changes resulting from infections of the Central Nervous System (CNS), particularly in laboratory animals such as non-human primates (NHP). Ultimately, a device of this nature will be desired to measure ICP in humans. The preferred device must rapidly and reproducibly identify increases in ICP in infected non-human primates; it would also be desirable if the data derived from this method be compatible with data obtained through the use of standard telemetry systems. 

PHASE I: Innovate a novel non-invasive device to measure intracranial pressure in a non-human primate. Demonstrate function using existing animal or human data or via a simulation of intracranial pressure without use of non-human primates. 

PHASE II: Further develop and test the portable (handheld), non-invasive ICP device in a non-human primate infected with an infectious disease. The infection should include CNS involvement and must induce an increased ICP. Infectious diseases of interest include but are not limited to: alphaviruses, West Nile virus, tick-borne encephalitis virus (TBEV), henipaviruses, etc., or bacterial agents that cause meningitis/encephalitis such as Neisseria meningitides, Streptococcal species, etc. 

PHASE III: PHASE III: Further development and refinement of the device developed in Phase II, for use in Food and Drug Administration (FDA) supervised Animal Rule studies conducted under Good Laboratory Practice (GLP). PHASE DUAL USE APPLICATIONS: A portable non-invasive device for measuring ICP has multiple uses in the civilian health care sector for treatment of patients with traumatic brain injury and encephalitis caused by bacterial or viral infection. 

REFERENCES: 

1: National Biodefense Strategy 2018. https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf

2:  Kawoos U, McCarron R, Auker C, and Chavko M. Advances in Intracranial Pressure Monitoring and Its Significance in Managing Traumatic Brain Injury. International Journal of Molecular Sciecne, Vol 16, Issue 12, 2015.

3:  Freeman W. Management of Intracranial Pressure. Continuum Lifelong Learning in Neurology, Neurocritical Care Vol 21, Issue 5, 2015.

KEYWORDS: Intracranial Pressure, Encephalitis, Diagnostic Medical Device 

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