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Task Book: Biological & Physical Sciences Division and Human Research Program
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Project Title:  Preventing Secondary Brain Injury by Early Detection of Cerebral Bleeding and Edema Reduce
Fiscal Year: FY 2014 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 04/01/2013  
End Date: 03/31/2014  
Task Last Updated: 07/23/2014 
Download report in PDF pdf
Principal Investigator/Affiliation:   Levinson, Mitchell  M.S. / Cerebrotech Medical Systems, Inc. 
Address:  1249 Quarry Lane Suite 120 
 
Pleasanton , CA 94566 
Email: mlevinson@cerebrotechmedical.com 
Phone: 925-399-5392  
Congressional District: 15 
Web:  
Organization Type: INDUSTRY 
Organization Name: Cerebrotech Medical Systems, Inc. 
Joint Agency:  
Comments:  
Project Information: Grant/Contract No. NCC 9-58-SMST03301 
Responsible Center: NSBRI 
Grant Monitor:  
Center Contact:   
Solicitation / Funding Source: NSBRI-RFA-SMARTCAP 
Grant/Contract No.: NCC 9-58-SMST03301 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) VIIP:Risk of Spaceflight-Induced Intracranial Hypertension/Vision Alterations (IRP Rev E)
Human Research Program Gaps: (1) VIIP03:We need a set of validated and minimally obtrusive diagnostic tools to measure and monitor changes in intracranial pressure, ocular structure, and ocular function (IRP Rev E)
Task Description: The goal of this project was to 1) improve the Cerebrotech Intracranial Fluid Monitor clinical prototype device design and 2) establish human feasibility through clinical trials. Both objectives have been achieved. The prototype was improved by 1) redesigning the mechanical patient interface, 2) improving the electronics to maximize signal-to-noise ratio, and 3) developing algorithms to correlate the intracranial fluid (ICF) volume measurements to intracranial pressure (ICP) measurements on patients in the ICU (Intensive Care Unit) with severe brain injuries. The study results demonstrate that ICF measurements correlate linearly with ICP in patients exhibiting good intracranial compliance. And, conversely, patients with poor intracranial compliance display a poor correlation of ICF to ICP. These results confirm our original hypothesis based on established neuroscience, and demonstrate the feasibility of non-invasive ICF monitoring using Volumetric Integral Phase-shift Spectroscopy (VIPS) technology. We believe our study was the first to demonstrate the relationship of intracranial fluid volume and pressure using real-time, continuous ICP and ICF measurements in human patients with brain injury. Continued clinical research and validation is warranted.

A proposed research plan for the coming year has been detailed in the March 24, 2014 proposal entitled, "Noninvasive Self-Contained Helmet Intracranial Fluid Monitor." Device iteration and development of a prototype helmet will demonstrate feasibility of a device configuration compatible with use in the International Space Station (ISS). Earth-based clinical validation of the prototype will be performed in association with the Baylor College of Medicine.

Research Impact/Earth Benefits: There is a glaring gap in diagnosing and monitoring patients for brain edema and bleeding. At most, CT (computed tomography) and MRI (magnetic resonance imaging) only provide daily snapshots, and other probes like intracranial pressure (ICP) monitors are extremely invasive and are only used in the most serious cases. Most patients are left largely unmonitored in their hospital beds, except for periodic subjective clinical neurological exams, leaving them exposed to a risk of undetected brain edema or bleeding, until it causes a significant and detectable neurological deficit—and by then it is too late. Cerebrotech will offer a completely noninvasive device for monitoring small changes in brain edema and bleeding, which will provide a continuous and objective measure of brain fluids and ischemia at the patient's bedside. Patients include over 3 million admitted each year worldwide for stroke, traumatic brain injury, brain surgery, and other disorders that place them at high risk for clinical degradation. Early detection of adverse changes in patient condition is the key to improving outcomes and reducing cost for hospitals and payers.

Task Progress & Bibliography Information FY2014 
Task Progress: The goal of this project was to 1) improve the Cerebrotech Intracranial Fluid Monitor clinical prototype device design and 2) establish human feasibility through clinical trials. Both objectives have been achieved. The prototype was improved by 1) redesigning the mechanical patient interface, 2) improving the electronics to maximize signal-to-noise ratio, and 3) developing algorithms to correlate the intracranial fluid volume (ICF) measurements to intracranial pressure (ICP) measurements on patients in the ICU with severe brain injuries. The study results demonstrate that ICF measurements correlate linearly with ICP in patients exhibiting good intracranial compliance. And, conversely, patients with poor intracranial compliance display a poor correlation of ICF to ICP. These results confirm our original hypothesis based on established neuroscience, and demonstrate the feasibility of non-invasive ICF monitoring using VIPS technology. We believe our study was the first to demonstrate the relationship of intracranial fluid volume and pressure using real-time, continuous ICP and ICF measurements in human patients with brain injury. Continued clinical research and validation is warranted.

Bibliography Type: Description: (Last Updated: )  Show Cumulative Bibliography Listing
 
 None in FY 2014
Project Title:  Preventing Secondary Brain Injury by Early Detection of Cerebral Bleeding and Edema Reduce
Fiscal Year: FY 2013 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 04/01/2013  
End Date: 03/31/2014  
Task Last Updated: 07/09/2014 
Download report in PDF pdf
Principal Investigator/Affiliation:   Levinson, Mitchell  M.S. / Cerebrotech Medical Systems, Inc. 
Address:  1249 Quarry Lane Suite 120 
 
Pleasanton , CA 94566 
Email: mlevinson@cerebrotechmedical.com 
Phone: 925-399-5392  
Congressional District: 15 
Web:  
Organization Type: INDUSTRY 
Organization Name: Cerebrotech Medical Systems, Inc. 
Joint Agency:  
Comments:  
Project Information: Grant/Contract No. NCC 9-58-SMST03301 
Responsible Center: NSBRI 
Grant Monitor:  
Center Contact:   
Solicitation / Funding Source: NSBRI-RFA-SMARTCAP 
Grant/Contract No.: NCC 9-58-SMST03301 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) VIIP:Risk of Spaceflight-Induced Intracranial Hypertension/Vision Alterations (IRP Rev E)
Human Research Program Gaps: (1) VIIP03:We need a set of validated and minimally obtrusive diagnostic tools to measure and monitor changes in intracranial pressure, ocular structure, and ocular function (IRP Rev E)
Task Description: Astronauts coming back from the International Space Station (ISS) can experience significant and permanent ocular damage which appears to be correlated with elevated intracranial pressure (ICP). To date, little is known about the causes of these pathologies, and NASA wants a non-invasive device to monitor the astronauts' brains in space. Cerebrotech is developing the first completely non-invasive monitor to detect changes to intracranial fluid (ICF). The device uses a proprietary technology called Volumetric Integral Phase-shift Spectroscopy (VIPS), which was developed at the University of California at Berkeley.

VIPS exploits the changes in electrical properties of tissue as a result of small changes in fluids. These changes in electrical properties can be detected by measuring the frequency response of the phase angle between a transmitter and receiver antenna as depicted below. The phase angle is a measure of the speed of propagation of the waves through the tissue, which is a function of frequency, impedance and dielectric constant. By taking a baseline reading, we can compare subsequent readings to detect changes to fluids in the brain. Since the bone and protein remain essentially constant, the changes we see are solely the result of fluid changes, such as bleeding and edema.

The Cerebrotech device consists of at least one transmitter and one receiver antenna placed to measure the fluids in the brain. Low-power electromagnetic waves at multiple frequencies are transmitted through the brain and the phase shift between the transmitter and receiver are measured. Because the different fluids in the brain cause different phase shifts at different frequencies, VIPS can differentiate between the fluid compartments. For example, we can see edema forming, movement of CSF, increases and decreases in intracranial blood volume.

Research Impact/Earth Benefits: There is a glaring gap in diagnosing and monitoring patients for brain edema and bleeding. At most, CT and MRI only provide daily snapshots, and other probes like intracranial pressure (ICP) monitors are extremely invasive and are only used in the most serious cases. Most patients are left largely unmonitored in their hospital beds, except for periodic subjective clinical neurological exams, leaving them exposed to a risk of undetected brain edema or bleeding, until it causes a significant and detectable neurological deficit—and by then it is too late. During this period, the physician knows little about the status of the brain, and orders thousands of dollars on serial medical imaging and nursing examinations, with little chance of detecting the problem in time to prevent secondary brain injury.

VIPS technology uses magnetic induction to detect small changes in the fluid volume of the brain. Patients wear it like a headband without requiring electrical contact with the skin. The monitor can be worn continuously to detect brain fluid changes from baseline, aiding the physician in detection of increasing brain edema or bleeding, as well as providing objective feedback for medical management and medication dosing.

The product will address a market of millions of patients worldwide, for an addressable market size of several billion dollars annually. The initial target application is patients in hospitals after stroke, traumatic brain injury or other conditions which put them at risk for secondary brain injury as the result of bleeding or edema. This application alone addresses the needs of 3.3 million patients worldwide.

Task Progress & Bibliography Information FY2013 
Task Progress: New project for FY2013.

[Ed. Note: Added to Task Book 7/9/2014, when received information about the task.]

Bibliography Type: Description: (Last Updated: )  Show Cumulative Bibliography Listing
 
 None in FY 2013