DESCRIPTION:  The brain monitor will apply existing technology: EEG and Rheoencephalography (REG) (Moskalenko, 1980; Jenkner, 1986; Anonymous 1997; Grimnes and Martinsen, 2008). The brain monitor will 1) detect the lower limit of cerebral blood flow autoregulation (Bodo et al -1, 2005; 2007; Czosnyka et al, 1997; Anonymous 2; and 2) detect failure of neuronal synaptic transmission (defined as a 2 second isoelectric EEG period (Prior, 1973, Bodo et al 2001). The brain monitor will have sufficient memory (minimum 80 GB) to store both the EEG and REG analog signals during transport of wounded soldiers and in the neurosurgery ICU. These records can later be stored and connected to the DoD computer-based electronic health record (CHCS II, AHLTA).

PHASE I:  Develop overall system design that includes specification of REG and EEG amplifiers, signal processing, data storage, monitoring, network connections.

PHASE II:  Develop and demonstrate a prototype system in animal and human studies. Conduct testing to prove feasibility over extended operating conditions.

DESCRIPTION:  If TBI is the signature injury of Operations Iraqi and Enduring Freedom (OIF/OEF), then PTSD and depression are the psychological correlates, each significantly contributing to life altering events or consequences for the service members, their families, and ultimately the community. Mild traumatic brain injury is strongly associated with emotional and physical health problems, of which PTSD and depression are important mediators.1 Approximately 19.5% of service members reported experiencing a probable TBI during deployment and 18.5% of all returning service members meet criteria for either PTSD or depression.2 There is a significant overlap between of military members who have experienced and/or witnessed a life threatening event and sustained a blast or other traumatic head injury. This overlap between traumatic brain injuries and co-morbid psychological disorders (i.e. PTSD, depression) in military service members requires further investigation.3, 4

The likelihood of having repeated deployments and cumulative mental and physical injuries are becoming more prevalent with the increasing number of multiple deployments. In addition, undiagnosed and/or untreated events occur, resulting in military members returning to the field and experiencing multiple blasts/ traumatic exposures. This repetitive and cumulative exposure, without appropriate time for rest and reset, has resulted in an overlap of psychomorphic conditions that are evidenced by emotional and neurocognitive changes.5

When able to rest, many military members have reported sleep pattern disturbances. These disturbances, often attributed to the combat setting or emotional disorders, may have a much deeper structural etiology in the TBI patient. A recent study discovered that individuals with closed head injuries had a higher incidence of sleep-wake cycle disturbances, resulting in longer stays in rehabilitation facilities, and additional emotional disturbances. These sleep cycle disturbances may serve as a marker for more severe injury and poorer outcomes.6

The awardee will assess the co-occurrence of these neurocognitive and emotional events, determine the problems and associated conditions, examine the long term implications and evaluate diagnostic instruments in order to distinguish who is most at risk for becoming impaired. This could ultimately aid in the determination of fitness for military duty and battle readiness. In addition, with more than 1.4 million people sustaining a TBI in the United States each year, the need for greater understanding of these injuries is evident in the civilian population as well.7

Currently, the standard of practice in the field has been to administer the Military Acute Concussion Evaluation (MACE), followed by further evaluation at the Battalion Aid Station (BAS). The MACE incorporates the Sports Concussion Assessment, therefore it is notable that most sports injuries include a single uncomplicated event that typically recovers within a week of injury, unlike the battlefield injuries noted above.8  Additionally, while this measure may have the sensitivity to detect severe brain injuries, some cases of mild brain injury may be missed; and this assessment does not include mental health measures which may identify psychological or emotional sequelae. Furthermore, validation of the MACE has not yet occurred.9

To date, there appears to be a large number of false negatives with current standard evaluative processes in the field. This results in delayed identification of patients who have been injured both medically and psychologically. Since most recovery of brain functioning occurs within the first 12 months, identifying these individual quickly and making sure they receive the proper evaluation and treatment in a timely manner is critical. There appears to be a need for a screening tool that addresses these needs and facilitates the triage process.

PERFORMANCE OBJECTIVES:
(1) Develop an evidence-based screening tool that is sensitive and specific to neurocognitive and emotional changes often seen in service personnel who have been exposed to blasts and/or closed head injuries. Results from this screening tool yield a predictability score, which signals whether more extensive evaluation is needed. The screening tool can be administered by paraprofessionals in the field who often serve as first-responders. This tool will be comprised of several already existent and well-researched neuropsychological measures. The neuropsychological tests chosen for this screening tool have been shown to be the most sensitive and specific indicators of both traumatic brain injuries related to over-pressurization (i.e., blast injuries) as well the emotional sequelae often associated with combat-related experiences.
(2) Once this brief screening tool is completed, an outcome prediction score is derived, which will determine if further and more thorough evaluations are warranted.
(3) Individuals obtaining scores above a preset cutoff will then be evaluated more extensively. Individuals who meet the criteria for clinical diagnoses, based on his /her level of impairment, will then be followed through longitudinal studies. These studies will examine rates of neurodegenerative processes, effects of sleep disorders and/or recovery rates for concurrent emotional disorders.

PHASE I:  In Phase I, the awardee will investigate the feasibility of obtaining de-identified patient data to build an empirically-derived screening tool. This screening tool will be a result of statistical analyses of several standardized neuropsychological and psychological test measures. This database will contain multiple data points which aid in the identification of appropriate test instruments, and then be used to validate the instruments with the identified patient population. Review of the existing literature regarding the use of these test measures/instruments and their predictive power, thereby allowing for the identification of the factors influencing the functional status of soldiers returning from deployments to OIF and OEF will occur during this phase. This phase also includes the preparation of plans and protocols for any required human testing, as well as seeking local and Army regulatory approvals for potential Phase II work. (Any Phase I animal or human subject research is highly discouraged unless existing protocols are already approved by local boards and can be quickly prepared for second-level review by the U.S. Army Medical Research and Materiel Command Office of Research Protections.)

The strengths of this screening tool should include:
• Based on standardized tests
• Test-retest measures can be used for longitudinal studies
• Empirically-based measures through multiple regression
• Brief, inexpensive, and sensitive
• First responders can administer and make recommendations based on prediction score (i.e., scores above cutoff warrants further evaluation)
• Extensive assessment training is not required to administer the screening tool
• Baseline measures can be obtained immediately after an injury and/or blast and provides baseline data for other healthcare professionals to monitor changes in neurocognitive and emotional functioning.
• Statistics to account for practice effects
• Aspire to establish validity indexes/scales to establish response style. For example, individuals may minimize, exaggerate, or feign underlying symptoms.

The results from Phase I will be used to improve the sensitivity, specificity and predictability of standard psychological and neuropsychological test results. This will enable more accurate diagnosis of psychological disorders and traumatic brain injury thus allowing more informed judgments about fitness for duty and battle readiness.

PHASE II:  In Phase II the awardee will conduct a retrospective study using a data pool, of at least 400 subjects, in order to identify the main areas of impairment that are observed in military service members exposed to blast wave injuries. Regression analyses and/or principle parts analyses should serve as the statistical measures. The data should include neuropsychological and psychological measures as well as multiple clinical data points including sleep/wake cycle disturbances, perceptual changes, presence and frequency of headaches, changes in energy level, changes in speed of thinking, medical history, psychological treatment history, etc. Other factors include MMPI-2 code types, the ANAM scores, measures of verbal/visual memory, attention/concentration, executive functioning, perceptual and processing speed, etc.

PHASE III:  A more predictive screening tool and standardized evaluation process will have widespread implications and applications for the care and treatment of neurologic and psychological patients in both military and civilian sectors. These tools will enable identification of domains of neurocognitive and psychological impairment. Long-term consequences of blast/PTSD and other co-morbid conditions will be examined to determine recovery patterns among injured personnel, including rates of recovery and related abilities to return to duty (including fitness for duty and combat readiness). Additional applications of this data include: Develop therapeutic models to facilitate the recovery process and expected outcomes of such interventions; Identify more effective rehabilitation interventions and the efficacy of such interventions in these conditions and explain how the expected brain dysfunction from a blast injury differ from general head trauma. The screening tool will ultimately lead to the development of a standard of care, diagnostic battery that is not only effective, but cost efficient, to enable quicker and more accurate diagnosis and a treatment algorithm which should allow for better care of not only the war fighter, but the civilian trauma population. Based on the data from Phase I and II, sleep studies may be warranted to evaluate sleep/wake cycles in persons with either traumatic brain injury and/or psychological disorders (i.e., PTSD & Depression); therefore the awardee should have the capability of performing these studies as well.

Further questions that may be answered from this data include:
- Does concurrent treatment of these disorders lead to better outcome than sequential treatment?
- Does the type of treatment have an effect on recovery?
- Is the stigma of treatment for psychological conditions lessened because of the TBI diagnoses?
- Are rates of degenerative nervous system diseases (Alzheimer’s, Parkinson’s, Amyotrophic Lateral Sclerosis) in persons with blast-related TBIs comparable to other TBIs from better researched areas of injury (e.g., motor vehicle accidents).

DESCRIPTION: In January 2008, the Department of Defense reported a total of 5,503 soldiers currently suffering with traumatic brain injuries (1). Mild Traumatic Brain Injury is the most common kind of combat injury frequently leading to cognitive deficits in attention, speed of information processing, and working and long-term memory performance. As many as 30% of patients with Mild Traumatic Brain Injury show neurological symptoms (e.g. headaches, dizziness, and irritability, and neurocognitive deficits) long after the initial head trauma. Early detection and screening of positive Mild Traumatic Brain Injury status is difficult in the immediate post-trauma period and new and efficient screening methods of assessment are needed. It is known that Mild Traumatic Brain Injury is strongly associated with sleep-wake disorder characterized by excessive daytime sleepiness, hypersomnia and fatigue. Recent research in non-military populations has shown that sleep quality and resulting sleep deprivation, may be responsible for these symptoms. Further, sleep disorders disrupt sleep consolidation of recent learning and resulting sleep deprivation is associated with impaired cognitive functioning.

This topic is searching for the development of new innovative methods to quantify the presence of sleep-wake disorder, poor sleep quality and other sleep abnormalities that is correlated with mild traumatic brain disorder in combat soldiers who have recently experienced head trauma.  This devise will be using different integrations and will be more sensitive than the one already approved by the FDA which cannot detect early enough the subtle change in sleep awake disorder that are seen in mild traumatic brain injuries.  Such devices or methods would allow the practitioner or military medical personnel  to characterize and identify patient status or risk of Mild Traumatic Brain Injury in the early stages before triage. 

Sleep disturbances can compromise the rehabilitation process of our Veterans and Military as well as affect their ability to return to work due to dysfunctional cognition from lack of sleep (2). A successful device could lead to a diagnosis and subsequent treatment of Mild Traumatic Brain Injury and contribute to corporeal and cognitive rehabilitation of these patients.

PHASE I:  Phase I work shall include proof-of-concept data that shows that the method(s) to quantify the presence of sleep-wake disorder, poor sleep quality and other sleep abnormalities will be able to provide data points relating to the identification of Mild Traumatic Brain Injury. During this phase, algorithms and parameters will be defined and proved. The results should include a proof-of-feasibility demonstration of primary concepts.

PHASE II:  The researcher shall design, develop, test, and demonstrate a prototype tool that implements the Phase I methodology to detect Mild Traumatic Brain Injury. The researcher shall describe in detail the plan for the Phase III effort.

DESCRIPTION:  The military is currently developing several robotic systems for both teleoperated and autonomous interventions for use in the operating room of the future (Cleary et al, 2004). Intuitive Surgical’s da Vinci® surgical robot broke ground in 1998 by performing the first tele-robotic surgery to repair a heart valve (Guthart & Salisbury, 2000), and Accuray’s CyberKnife radiotherapy robot began treating head, neck and upper spine tumors in 1999 by combining image guidance with a robotically-directed radiation beam (Adler et al., 1997). Ultrasound represents one of the most promising new technologies for use both on and off the battlefield. High-resolution ultrasound imaging can be used to detect internal bleeding (Alvarado et al, 2008) and bone fractures (Lo et al, 2008), and an ultrasonic welding device is now being applied as an alternative to manual suturing (Garcia, 2007). During these procedures, it is typically required that a specified level of force be applied on the patient, which is made particularly difficult because of the compliance of soft skin tissue and involuntary movements due to respiration. It is extremely difficult for a serial-link manipulator to respond quickly enough to accommodate this motion due to high inertia and inaccuracies caused by low stiffness at the tool point. Ultrasonic probes have been mounted and demonstrated on parallel manipulator devices (Ding et al, 2008), but the range of motion is very limited. Alternatively, serial-parallel robot architectures can be implemented in which the serial robot moves the probe into close proximity of the patient, while a parallel mechanism end-effector maintains constant force contact of the probe using minute adjustments (Carbone and Ceccarelli, 2005). In addition to providing increased accuracy and bandwidth, a robotic end-effector mechanism will also yield increase the level of safety through active compliance. Several technologies are potential candidates for this research topic, although dc electric motor-based technologies are preferred. Approaches that could potentially be used include using linear joints such as lead-screws or pistons currently employed in Stewart platforms or rotary joints to drive differential gears to cause multi-axis movement of linkages. In addition to novel end-effector design, research challenges inherent in this topic include actuator devices, colocated sensing, mechanical efficiency, miniaturization, ruggedization, local processing, communication, and packaging. For example, colocated sensing represents a particular challenge due to the close proximity of the actuators and rugged environment in which the device must operate which may be inhospitable to optical encoders typically employed in these applications.

PHASE I:  Conceptualize and design a prototype parallel end-effector mechanism that meets the following requirements: mass < 5 Kg, force > 50 N, torque > 5 N-m/rad, force resolution < 0.5 N, position accuracy < 2 mm, position repeability < 0.5 mm, stiffness > 10000 N/m, range of motion 5 cm translation and 30 deg rotation, and diameter < 15 cm x height < 15 cm. Develop a research plan for Phase II.

PHASE II:  Develop, integrate, and test a prototype parallel end-effector mechanism that meets the Phase I requirements. Design and implement a controller that can achieve active compliance of less than 2 N/cm up to 10 Hz bandwidth. Demonstrate this system on a serial-link manipulator used in a surgical suite such as a Mitsubishi PA-10 manipulator. Develop a commercialization plan for Phase III.

DESCRIPTION:
In recent military conflicts involving American military personnel, such as Operation Desert Shield/Storm and Operation Iraqi Freedom the majority of injuries (60%) that required hospitalization and transport from theater involved injuries to the extremities (1-3). It can be assumed that these injuries involve losing large portions of muscle, bone and/or missing skin. Currently, the clinical treatment of extremity and cranio-facial trauma confront the challenge of poor regenerative potential and inferior function after repair, which can lead to extended rehabilitation, multiple surgical procedures and possibly permanent disabilities. Recent advances in tissue engineering indicate that adult stem cells and biomaterials may provide a source of regenerative tissue that may be clinically useful for de novo formation of muscle, bone and skin lost to trauma (4,5).

There is a need to develop new natural material matrices for biomedical research and tissue engineering applications. Such materials must be biodegradable, easily formulated and mimic the mechanical attributes of the injured tissue, produced in various formulations (e.g. gel, sheet) and porosity, as well as easily isolated and manufactured in large quantities.

PHASE I:  Identify a natural polymer or family of polymers the can be used to repair or replace portions of or whole tissues (i.e. bone, muscle, skin). The system must replicate the structural and mechanical properties of each tissue and produce functional equivalent tissue in vitro, so the engineered product can replace, restore or improve tissue/organ function. The material should be non-toxic and encourage cell attachment, proliferation and differentiation.

PHASE II:  Test the efficacy of the materials in vivo and determine the preferred embodiment for each tissue type in animal experimental models. The safety (i.e. toxicity and immunogenicity) of each combination of biomaterial in vivo should be determined and necessary redesign based on performance evaluated.

PHASE III:  The most promising biomaterial formulations will be analyzed in additional in vitro assay and in vivo tested in a more realistic large animal model. The overall program will provide natural biomaterials that can be used for reconstructive surgery and be effectively commercialized for both civilian and military trauma care.

DESCRIPTION:  In recent military conflicts involving American military personnel, such as Operation Desert Shield/Storm and Operation Iraqi Freedom the majority of injuries (85%) that required hospitalization and transport from theater involved injuries to the extremities and craniofacial region(1-3). Many of these injuries involve losing large portions of muscle, bone and/or missing skin. Currently, the clinical treatment of extremity and cranio-facial trauma confront the challenge of poor regenerative potential and inferior function after repair, which can lead to extended rehabilitation, multiple surgical procedures and possibly permanent disabilities. Recent advances in tissue engineering indicate that adult stem cells and biomaterials may provide a source of regenerative tissue that may be clinically useful for de novo formation of muscle, bone and skin lost to trauma (4,5).

There is a need to develop new devices for tissue engineering applications. Such devices must be flexible (i.e., modular components), autoclavable (or disposable) and easily adaptable to function with pre-existing laboratory equipment.

PHASE I:  Identify a device or technology that can be used to repair or replace portions of, or whole tissues (i.e. bone, functional skeletal muscle, and skin). The device should provide a biomimetic environment to fabricate tissues using a wide variety of biomaterial and stem cell combinations. The system must replicate the structural and mechanical properties of each tissue and produce functional equivalent tissue in vitro, so the engineered product can replace, restore or improve tissue/organ function. The size of engineered tissue constructs is almost always limited by diffusion; therefore, this bioreactor must promote vasculogenesis and bring the field closer to the goal of implantable, functional tissue.

PHASE II:  Test the efficacy of device(s) and determine the preferred embodiment that will be fabricated and tested in vitro and in animal experimental models. The device and necessary redesign based on performance will be evaluated.

DESCRIPTION:  Recent news reports, notably those involving the deaths of Army Sergeants Gerald Cassidy and Robert Nichols, have emphasized the fact that TBI and PTSD patients are receiving many medications to treat their conditions. Such a situation increases the possibility of adverse drug events, which can lead to the unnecessary illness, or in these cases, deaths of patients. In Nichols’ case, eleven drugs were found in his body at autopsy. It is highly likely that other TBI and PTSD patients are at risk from complex drug interactions or over-dosing a combination of drugs. The situation becomes even more complicated when multiple drugs are prescribed and the patient is drinking alcohol or taking over the counter drugs and supplements. Increases in risk-taking behavior and/or physical and emotional pain related to TBI and PTSD can also result in taking drugs of abuse which again adds to the complexity of the issue.

There has been little research directly addressing the problem of poly-drug treatment of TBI and PTSD patients. The Military Health System does recognize that current information technology management systems to promote pharmacovigilance and prevent adverse drug events, near misses, and sentinel events suffer from the issue of disparate disease classification, evaluation and management, and differing drug adverse event reporting terminologies.

The proposed SBIR will build upon the current, very early state of research in use of semantic web technologies in healthcare. Conducting pharmacovigilance and post-marketing drug surveillance often requires combining disparate sources of data which are based on disparate medical concepts and terminologies. It is often difficult to mediate differences in medical concepts terminologies to make sense out of the data. Using semantic web technologies can help clinicians and researchers understand differences in medical concepts and terminologies.

For example, electronic health records contain medical terminologies which represent knowledge of disease classifications and evaluation and management of the patients, such as Medicomp MEDCIN, ICD-9, ICD-10, CPT-4, LOINC, SNOMED, and others. On the other hand, adverse event terminologies are largely based on MedDRA, the Medical Dictionary for Regulatory Activities, although other reporting taxonomies have also been developed and are in use. MedDRA is a pragmatic, medically valid terminology with an emphasis on ease of use for data entry, retrieval, analysis, and display, as well as a suitable balance between sensitivity and specificity within the regulatory environment. MedDRA terminology applies to all phases of drug development, excluding animal toxicology. It also applies to the health effects and malfunction of devices. The size and complexity of MedDRA terminology carries the risk that different users may select differing sets of terms while trying to retrieve cases relative to the same drug safety problem. It has also been stressed that the active participation of drug regulatory authorities in the preparation of search queries is essential for their subsequent acceptance of search results and that there is a need to agree upon how the search results should be presented using a specially designed template.

One area of immediate interest to the Military Health System (MHS) is how to map ICD-9 and ICD-10 to MedDRA. This might be accomplished using UMLS or the other code sets contained within, such as SNOMED 2, or through use of the existing 3M HDD product in the Armed Forces Health Longitudinal Technology Application (AHLTA).

Another area of potential interest is how to automatically map institutional-specific terms and codes that are developed in electronic medical record systems at military treatment facilities (MTFs), such as in CHCS and AHLTA. Users need a way to track when theses terms and codes came into use at the institution, and when they are entered into the system’s central health data dictionary (HDD), which is a 3M commercial product. Once changes are made in one system, they need to automatically update the other systems involved.

The same is true for Logical Observation Identifiers Names and Codes (LOINC) codes for labs, and cohort specific data such as smoking, body mass index (BMI), radiology, and other cohort specific data. 3M NCID codes may be able to address the mapping of LOINC, ICD-9, ICD-10, and Drug Codes.

Another reported area of concern is that the Department of Veterans Affairs uses a different drug dictionary than most others; additional terminology mediation may be necessary here.

The research should determine if it is feasible to leverage the 3M Health Data Dictionary, which is currently used to normalize lab results coming from MHS CHCS to the MHS AHLTA system using a unique Numeric Concept Identifier (NCID), and contains multiple cross-mapping of tools, for use in other systems which support pharmacovigilance.

This option needs to be evaluated along with using other meta-thesauri, such as the Unified Medical Language Service (UMLS), or other medical ontologies, such as LinkBase from Language and Computing.

The research should also examine whether these knowledge representation schemes, meta-thesauri, and/or ontologies are compatible with the RDF and OWL technologies employed by the Semantic Web.

This research may also explore ways of semantically exchanging data with the FDA Sentinel Network concept, if the FDA is willing to commit resources to this SBIR. Through Sentinel, FDA intends to capitalize on emerging technologies and new sources of data. Its goal is to be able to mine claims data and electronic health records to help ensure that medical products are optimally used in post-marketing settings.

The research may also determine how semantic web technology may be best applied to exchange of Military Health System data with the JANUS Clinical Data Repository. This may or may not involve extended use of the 3M HDD. As a matter of background, JANUS is a standards-based clinical data repository that utilizes the open source data model, Janus. This repository provides a data collection and analysis warehouse for clinical trial data submitted for protocols (what was supposed to happen) as well as clinical outcomes data (what did happen - events, interventions, etc.). When implemented, Janus will enhance the clinical trial process by allowing the viewing of the data through reviewer-centric tools; cross-study analyses; cross-application analyses; audit capabilities; and enhanced communication of conclusions. It will contain patient information as well as intellectual property information of the sponsor agencies that have supplied the investigational agents. The JANUS vision is to incorporate SAEs (ARES type data), so that could bring the whole lifecycle of any drugs ( pre-market, post-market ) safety data together in future, and provide a better understanding for any drugs safety evolution. Janus uses NCI''s EVS (enterprise vocabulary service) which contains a lots common terminology that is also available in UMLS.

NDC (National Drug Code System) is the common coding system used for clinical drug trials and for post-marketing drug surveillance drugs. NDC is not included in UMLS, and thus not part of the Janus Environment.

Given this barrier to semantic interoperability, as one idea, this SBIR might create a drug ontology engine that:

a. maps between NDC to the drug naming schema used in Janus (SNOMED); this would be essential to bridge the huge gap between pre-market and post market drug safety analysis in FDA

b. unifies NDC (and other clinical use drug code, like VA’s drug file) with drug terminology used in clinical research world provide the tool to facilitate DoD commitment to take part in the national sentinel network: seamlessly integrate MHS clinical data to national research environment

c. strengthens DOD‘s ability to utilize multiple data source to conduct post-market pharmacovigilance activities to make better informed decisions to guild our drug use safety

d. enhances data analysis capabilities through building enriched drug entity attributes/characteristics.

PHASE I:  In Phase I, the SBIR awardee will meet with MHS to refine the problem and research objectives. The awardee will meet with other interested government agencies already working with DoD, such as FDA and VHA, to the extent that they are available and interested.

The awardee will leverage past research involving the application of semantic web technologies to healthcare surveillance, pharmacovigilance, post-marketing drug studies, and drug-related near miss/adverse/sentinel event reporting, with a focus on TBI and PTSD patients.

The awardee will also conduct a survey of semantic web tools which currently exist, such as those developed by Dr. Parsa Mirhaji at the University of Texas, Health Science Center, Houston, and others, such as those licensed by Apelon, Language and Computing, and 3M, as well as other open source tools. The vendor should conduct a test of the accuracy of such tools in translating various code sets to MEDDRA and vice-versa.

In addition the government is interested in applying semantic and ontological-based Natural Language Processing technologies to free text in radiology and pathology reports to output codes.

The awardee will assess architectural alternatives for applying semantic web technologies to mediate differences in terminologies between MHS and external systems which collect or feed data in these domains. Which systems would be involved would be determined in an analysis of alternatives. The likely MHS systems involved might include AHLTA, CHCS, the MHS Clinical Data Mart (CDM), the MHS M2 Business Repository, or the MHS Patient Safety Reporting System, or others, including those in the FDA. (The research will not focus on record level error reports as found in USP MEDMARX).

Emphasis will be on outlining a systems, operational, and technical approach to achieving semantic interoperability for data exchange between MHS systems, and/or between MHS and FDA systems, such as JANUS, with a focus on how terminology differences can be mediated. Whether JANUS will be involved is dependent upon resources available at the FDA and CDC. The focus will remain on mediating terminology in the TBI and PTSD domains.  Phase I will also determine the metrics by which success will be judged. Likely metrics would measure the degree to which semantic web technologies can provide automated, accurate mappings of terminologies, and/or improved understanding of disparate data by researchers and clinicians, with a focus on the TBI and PTSD domains.

PHASE II:  In Phase II, the SBIR awardee will build a prototype system(s) demonstrating how semantic web technologies can be applied to achieve exchange of data with semantic interoperability, based on the architecture defined in Phase I, and focusing on the TBI and PTSD domains. The prototype system(s) should show exchange of data between MHS systems involved with pharmacovigilance, post-marketing drug surveillance, and/or drug adverse event reporting, or between MHS system(s) in these domains and the NIH/FDA JANUS clinical data repository. The systems involved would be determined in Phase I.

PHASE III:  In Phase III, the SBIR vendor would transition the prototype system(s) to production quality system(s), or exchange of data between existing systems. This would involve the complete design, development, testing, deployment, and sustainment of the system, under the oversight of the TRICARE Management Activity Joint Medical Information Systems Office (JMISO) and Military Health System Chief Information Officer, through an IT Program Office, such as Executive Information/Decision Support. Functional clinical champions would be designated at the TRICARE Management Activity, and would likely include the DoD Pharmacy Program and Army Surgeon General’s Office. The system will also be refined to function with civilian based electronic health records systems of potential customers.

DESCRIPTION:  Traumatic brain injuries are often associated with spinal injuries. Air transport of these injured patients is critical to obtain life and function-saving treatment in a medical facility with neurosurgical capabilities. Immobilization of traumatically injured patients during transport is essential in reducing risk of further spinal injuries. Some co-morbidities associated with spinal cord injury patients are secondary to improper immobilization and include pressure sores and destabilization of fractures. Forces that are exerted on patients evacuated in either fixed wind or rotary aircraft include torsion from turbulence, gravitational and vibratory effects from the aircraft. Additionally, military pilots may have to resort to rapid ascent/descent as well as erratic maneuvers to avoid hostile fire. These forces require unique stabilization techniques to prevent additional injury and improve transport for the injured warfighter. In the past, the Stryker frame was used to rotate patients to limit pressure sores. As the military phases out of this system, we believe that technology has advanced to the point where bedding systems can be used without the need for rotating the patient (and without the size and space required for that).

This topic proposes that the awardee will assess the forces acting upon military trauma patients and develop/refine methods to develop an immobilization device that permits victims of head and spinal column trauma to be firmly supported for transportation. The technology should be capable of head, cervical, thoracic, and lumbar support and cervical traction as needed. The device can be created by either moving new research into development or integrating existing technologies to develop the desired product. We require a portable, lightweight system that can be easily carried into field hospitals and used to move patients to the flight line and through air evacuation. Weight and safety considerations imposed by the aircraft must also be taken into account by the awardee (e.g. must conform to size and securing requirements for standard NATO litters). It must be practical to allow for manipulation of ancillary support equipment (e.g., ventilators, oxygen, monitors, intravenous drips with pressure bags, chest tubes, etc.) on-board the aircraft without impairing access to the patient. Additionally, weight bearing and prevention of pressure sores and skin erosion should be considered when developing materials for this device. Finally radiological and surgical considerations (e.g. access to wounds of the side and back) should be taken into account when developing the immobilization device and materials not compatible with X-Ray or Computed Tomography should be avoided.

Requirements of the system include:

1. Ability to fit in NATO standard litter restraints/ Compatible with standard Over Sized Litter (OSL).
2. Immobilization for patients with unstable cervical spine trauma and for unstable thoracic and lumbar spine injury.
3. Transportable via most fixed wing and rotary Air Evac aircraft
4. Permit access for medical treatment and airway control and permit prone and supine transport as well as access to back-wounds/surgical sites.
5. Man-portable to enable CCAT & AE teams to safely transport spinal injuries using 2-4 person carry.
6. If stand-alone carrier, must accommodate AE approved med pumps, vital signs monitor, and oxygen, preferably below the patient.
7. If an air or liquid based mattress is used, should include closed loop control system to monitor and respond to developing pressure points on patient.
8. Air or liquid based systems should also be capable of closed loop adjustments for changes in pressure with altitude change.
9. Splint systems must be able to monitor pressure points and adjust to reduce pressure on patient.
10. Must permit raising or lowering patient’s head to manage intracranial pressure and comfort.
11. Utilizes novel self cleaning or easily cleaned liquid-proof materials to enable keeping patient dry.
12. Must be able to be used with emerging advanced litter systems (LSTAT, LSTAT Lite, etc. This is preferable) if not a stand alone system.
13. Monitoring systems must be capable of being integrated with existing/planned monitoring systems for advanced litters.
14. Must include ability to warm patient and potentially cool patient if practical application can be developed.
15. Patient must be able to remain in system for a minimum of 12 hours without incurring additional morbidity/injury.

PHASE I:  The goal of this phase is to assess the requirements and then demonstrate the feasibility of developing a lightweight, pressure and shock absorbing transport system to improve stabilization of subjects with traumatic brain (TBI) and spine injuries during fixed wing and rotary air evacuations. Evaluation of forces acting upon patients, and patient’s ability to tolerate these forces will occur during this phase. A review of ancillary devices and weight restrictions required for transportation should also occur. A review of current and emerging technologies to include: investigation of materials and systems to prevent skin ulceration; assessment of rapid setting foams for splinting; air or spring systems; fluid shock absorbers; integrated pressure monitors and controllers should be completed. Phase I will result in design plans and documents, and model systems resulting from the assessment.

PHASE II:  Based upon the data and design plans obtained in Phase I, the awardee will develop a prototype of the stabilization system. Development of field test objectives and conducting limited testing demonstrating airworthiness should also occur in this phase. The Required Phase II deliverables will include a well-defined prototype that addresses the requirements discussed above. Initial FDA review requirements will be addressed.

PHASE III:  Secondary injuries resulting from transport of traumatically injured patients is preventable with an appropriate mobilization system. The development of such a system will have widespread application for care of neurosurgical patients in both military and civilian sectors. The safe transport could clinically improve the outcome and subsequent cognitive rehabilitation, by preventing additional secondary neurologic decline as a result of the extreme forces exerted on the patient in the aircraft. Success of this endeavor would provide improved medical-evacuation of civilian trauma patients from remote locations where trauma might be due to motor vehicle or water craft accidents, mountain climbing, falls, etc. It may also be used as an additional tool for the US Coast Guard in the prevention of secondary trauma when transporting victims by USCG boats or aircraft.

The prototype developed in Phase II will be further evaluated in Phase III for transition into a viable product for sale to the military and private sector markets. A plan including how FDA approval will be achieved, utilizing current Good Manufacturing Practices (cGMP), Quality Management and device applications will be developed and executed. Appropriate acquisition authorities within the Army medical department will be engaged should a successful solution result.

DESCRIPTION:  In current theaters of operation ground ambulances are not used outside the forward operating bases. The Army is faced with replacing the current ground evacuation vehicle with the new MRAP Heavy Armored Ground Ambulance (HAGA) version. These armored vehicles are going straight to Iraq and Afghanistan. This new Ground Ambulance called the HAGA is an upgraded vehicle from the MRAP and is used for evacuation of patients in theatre.

Army medics will not have the opportunity to train “casualty evacuation” on these new ambulances during medical training; instead they must wait until they get to Iraq or Afghanistan. This is a capability gap, not only will loading and unloading patients be needed, but additional medical equipment can be brought with the evacuation asset to augment the equipment the medic currently has. HAGA’s payload and advanced design features allow the medic to administer to three critical patients in reconfigurable litter stations. When the litter racks are folded in a stowed position, the medic can attend to as many as six ambulatory patients in a bench seating configuration. Additionally, the HAGA has more storage capacity for medical care items, medical equipment, and oxygen tanks compared to current force medical vehicles. It also has state-of-the-art exterior and interior lighting systems for patient care and features four headsets for improved internal communication.

Patient care scenarios need to be practiced and rehearsed prior to deployment. Currently only HAGA operators receive a five-day training course teaching Soldiers how to operate and maintain the ambulances. Training needs to be provided to combat medics as well. There are many advantages of virtual training systems, such as the benefits of the cost saving of gas, reducing damage of using the real vehicles, maintenance cost, and spare parts. This topic will implement the concepts of crawl, walk and run: using the computer base training first, then real vehicles and finally being in theater. These low-cost simulations will provide medics with a virtual walk through of these new ambulances where they can practice and rehearse using the medical equipment that is now built into the HAGA. This virtual walk through would also give students an idea of where the medical equipment is located in the vehicle and what it is used for. Most ambulance mockups do not include the medical equipment set, so a virtual computer simulation would help them understand what is available and what it is used for. Communication could also be practiced at the “point of injury” to the next level of care (Battalion Aide Station) with communication of injuries, treatments given, etc. during this hand-off of the patient. Interviews coming back from medical personnel in theatre state that lack of current training have caused safety and survivability considerations, such as not enough space to work on patients; don’t know how to use equipment, not enough storage space, etc. Individual body armor had to be removed to move around the inside of the HAGA due to limited space. Medics were not ready to use the MRAP/HAGA.

The goal of this SBIR effort would be to explore current and emerging technologies that offer new, innovative approaches to provide realistic, relevant, anywhere, anytime training for the Army medic. Another goal is to provide accurate feedback on performance of the trainee. It has been shown that virtual simulations effectively prepare Soldiers for real war.

PHASE I:  Conduct a feasibility study and describe overall system architecture for a medical virtual training system that trains the tasks during casualty evacuation of a patient. This system should use scenario based training exercises for use in the current training Program of Instruction (POI) at the Department of Combat Medic Training (DCMT) Ft Sam Houston Texas. DCMT supports this effort, as they requested a system such as a virtual evacuation trainer to be used for training medics in the Tactical Combat Casualty Care course. Training Objectives and performance metrics should be identified during this phase.

PHASE II:  Develop, test and demonstrate a prototype system from the recommended solution in Phase I. Provide realistic and meaningful interaction for medics with a new virtual MRAP Vehicle/ ambulance in a relevant Training environment.

DESCRIPTION:  Research conducted by Walter Reed Army Institute of Research (WRAIR) has shown that 20-40% of Soldiers returning from Iraq and Afghanistan experience mental health problems serious enough to impair social or work function, including Post-traumatic Stress Disorder (PTSD). Recent studies suggested that PTSD is often associated with concussion, a mild form of traumatic brain injury (TBI). WRAIR studies also showed that more than half of Soldiers identified with serious behavioral health related symptoms did not seek treatment [1]. Identification of affected or at-risk soldiers is key to early intervention and successful treatment. For sufferers of PTSD, sleep disturbances are among the most treatment-resistant symptoms and can lead to drug and alcohol abuse, even suicide [2]. While fully attended polysomnography (PSG) carried out in dedicated sleep laboratories (Type-I monitoring) has proven effective in diagnosis and treatment of certain types of sleep disorders, such contact-sensor-based procedures are both invasive and expensive, and can only be expected to reach a small portions of those affected. A portable, non-contact sleep monitoring system provides a highly accurate diagnostics tool which can be used in the hospital or at home that does not interfere with patients’ sleep, and provides a robust solution that is non-invasive and economical enough to be referred to all soldiers returning from combat, with the aim of identifying those most at risk [3]. We are seeking innovative and creative research and development efforts, for example Doppler radar based, that would benefit Battle Casualty and Psychological Health Research addressing diagnosis, treatment, and mitigation of deployment related injuries and psychological health concerns. This is in accordance with the Military Operational Medicine Research Program to manage efforts directed toward Suicide Prevention and Counseling Research.

PHASE I:  Conduct research to provide a proof of concept demonstration of a non-contact, portable, sleep disorder monitoring prototype. The concept will be original or will represent significant extensions, applications, or improvements over published approaches and the current technological limitations described above. Design and performance considerations for a proof of concept demonstration are listed below.
1. The prototype system must include measurement of two respiratory variables (e.g., respiratory movement and airflow), and a cardiac variable (e.g.., heart rate or electrocardiogram).
2. The prototype system must be portable, non-invasive and non-contact to the patient, and completely independent of the sleeping surface.
3. The prototype system must include an automated wireless interface for data transfer from the sensors to a remote processing unit.
4. The prototype system must include positive subject identification, including interference from subjects in the proximity of the wireless signal.
5. The prototype system must be capable of collecting data for at least 24 hours, and transitioning to a battery operated device.

PHASE II: Validate the Phase I prototype by demonstrating performance comparable to attended sleep laboratory technology, but suitable for unattended use. Develop, test and demonstrate diagnostic capability with built-in alarms. Test system performance under different environmental conditions to ensure accurate operation in field, hospital, and home environments likely to be encountered for use.

PHASE III: There are clear commercial opportunities for an unobtrusive, non-contact sleep monitor, based on patterns of respiration [4,5]. The major military applications are for PTSD and TBI diagnostics and monitoring in field, hospital and home environments. The major civilian application for this technology is next generation of sleep monitoring devices for obstructive sleep apnea (OSA). Research indicates that 40 million Americans suffer from insomnia and chronic sleep disorders, with over 12 million Americans suffering from OSA. The estimated direct annual cost for OSA is estimated at $16 billion [6].

DESCRIPTION:  Traditionally the Army has used a concepts, now capabilities, based development system for introducing new technologies into the battlefield. Essentially this is a serial process which involves time consuming analysis of operational problems combat developers who consider a wide variety of approaches to filling gaps in current operational doctrine and procedures. Working through this long and cumbersome process often results in technologies which are already obsolete upon fielding or no longer meet the operational needs of the users. Various attempts have been made to shorten or circumvent this serial process including introducing a “rapid equipping force” to take technologies directly to the battlefield for testing with troops and so-called “spiral development” which portends to field technologies or system components when ready, regardless of the technology readiness of the overall system for which they are being developed. Inherent in these approaches is the Battle Lab, where the Combat Developers can experiment with new concepts and technologies in simulated or live exercises with or without troops to generate or validate new concepts. Integration of new technology into Battle Lab exercises early in its development with direct participation from the Materiel Developers including the Science and Technology subject matter experts has been shown to greatly improve both the combat and materiel development processes. Full integration of new and emerging technologies within Battle Lab operational exercises and assessments first requires integration of the technology and its physical characteristics and candidate tactics, techniques, and procedures within the Battle Labs’ operational simulation programs. If conducted early on in the prototyping process rather than after a prototype is considered “ready for transition”, the process of conducting repetitive integrated simulated and live user exercises with both computer models of new and disruptive technologies and working prototypes has great potential for both speeding up and improving the design and development process. Currently there are no suitable physical or operational simulation models of emerging medical technologies within the operational simulation system most prevalent at Army Battle Labs, i.e. OneSAF (Simulated Autonomous Forces) (Refs 1-4, 9-10). Likewise there are no combat casualty or patient models within OneSAF that can be used to assess or evaluate the effectiveness of a new medical technology or treatment technique when used by a combat life saver or combat medic during small unit maneuver exercises or simulations. An open systems specification and interface tool prototype for interfacing combat casualty care medical capabilities and devices (real or simulated) to the OneSAF computer generated forces simulation system is needed in order to conduct operational assessments and evaluations of potential combat use of emerging medical capabilities and technologies at Army Battle Labs. Such a tool would also likely require a patient physiological model from which to measure the effects of the candidate medical capability or technology on casualty survivability and outcomes. (Refs. 5-6). Additionally, model interface with OneSAF must be High Level Architecture (HLA)/Distributed Interaction Simulation (DIS)) IEEE 1516, IEEE 1278 compliant (Refs 9,10). For simulations that are intended for the Army Future Combat Systems Command and Control, the preferred language is Battlefield Management Language (BML) (Ref 11).

PHASE I:  Design and show a proof of concept for an open systems specification and interface tool prototype for interfacing combat casualty care medical capabilities and devices (real or simulated) to the Army’s One Semiautonomous Forces (OneSAF) computer generated forces simulation system so that potential for combat use of emerging medical capabilities and technologies can be assessed and evaluated at Army Battle Labs within tactical exercises and simulations. Conduct a market survey of relevant military and potential civilian applications, such as emergency first responder simulation systems used by government (e.g. Department of Homeland Security), private or volunteer emergency services organizations to train first responders and assess new medical first responder technologies for natural disasters and other civilian emergencies; prepare an initial commercialization plan for the Phase II proposal.

PHASE II:  Prototype and demonstrate the Phase I open systems specification and interface tool prototype for interfacing combat casualty care medical capabilities and devices (real or simulated) to the Army’s One Semiautonomous Forces (OneSAF) computer generated forces simulation system so that potential for combat use of emerging medical capabilities and technologies can be assessed and evaluated at Army Battle Labs within tactical exercises and simulations. Using the prototype tool demonstrate generation of working OneSAF models for four emerging medical first responder technology prototypes suitable for use by combat lifesavers and combat medics during infantry platoon offensive operational exercises, such as might be run at the Fort Benning Maneuver Battle Lab. The four prototype technologies should include: 1) an automated casualty assessment or triage tool, 2) a robotic assisted casualty extraction system, 3) a first aid tool such as the one-hand tourniquet and 4) an emerging enroute care technology such as the portable hand-held field fluid/blood warmer or the Life Support for Trauma and Transport – Light (LSTAT-Lite) (Refs 7-8). Demonstrate measurement of the effect of the first responder’s employment of these technical capabilities on casualty survivability and outcome via a working patient physiological model. Prepare a more detailed Phase III commercialization plan based on detailed analysis of the Phase I market survey of relevant military acquisition programs and potential civilian applications.

PHASE III:  Assist Government technical monitor in transitioning to the Army Training and Doctrine Command (TRADOC) Battle Labs, the open systems specification and interface tool prototype for interfacing combat casualty care medical capabilities and devices (real or simulated) to the Army’s One Semiautonomous Forces (OneSAF) computer generated forces simulation system so that potential for combat use of emerging medical capabilities and technologies can be assessed and evaluated at Army Battle Labs within tactical exercises and simulations. Execute the commercialization plan developed in Phase II extending the model generation tool to other relevant military and potential civilian applications identified in the market survey, such as emergency first responder simulation systems used by government (e.g. Department of Homeland Security), private or volunteer emergency services organizations to train first responders and assess new medical first responder technologies for natural disasters and other civilian emergencies.

DESCRIPTION:  Due to advances in body armor and the preferred choice of weapons being explosive devices used against the war fighters in the Global War on Terrorism campaigns, extremity injuries have grown in its contribution to morbidity and mortality. The nature of warfare has changed from previous wars where the enemies will continue to use this type of weapon to inflict maximum damages at low cost. These resulting injuries are complex such as comminuted fractures as well as composite musculoskeletal and nerve tissue loss, where some part of the extremity is viable but lack of optimal treatment options sometimes necessitate limb amputation versus reconstruction surgeries that could lead to optimal/normal functional restoration and outcome. In cases of facial injuries, the current reconstructive options require multiple rounds of surgeries, and powerful pain medication that must be weaned off each time that do not even come close to desirable outcome in terms of both aesthetics and function. Such injuries also accounts for significant number of war fighter’s not fit for returned to duty status, longest average inpatient stay, accounting for 65% of the $65.3 million total inpatient resource utilization, and 64% of the $170 million total projected disability benefit costs and extrapolating this cost could yield total disability costs of $2 billion (1). Aside from the cost issues, all injured warfighters want to live and function like their pre-injured state. Advances in stem cell science, biomaterials, and tissue engineering could help in repairing/restoring damaged complex tissue (i.e. nerve, muscle, and tendon) resulting from direct impact of traumatic injury or due to secondary mechanisms of damage such as compartment syndrome (2-5). Current developments often focus on developing biomaterials for tissue engineering and regeneration of a single tissue type, while the injuries are often complex tissue loss. There is a need to develop novel, biodegradable/resorbable biomaterials combined with advances in (stem) cell biology/development and tissue engineering, to engineer an environment capable of supporting cell growth, differentiation, revascularization, and communicate with the injured environment to minimize inflammation and/or prevent/minimize infection.

PHASE I:  Develop novel, biodegradable/resorbable biomaterials that will promote complex tissue and/or bone healing, resulting in eventual tissue and/or bone replacement of complex tissue injuries. The biomaterial should be off-the-shelf use and should provide an environment that will support cell growth (at least 1 cubic centimeter), differentiation, revascularization, and communicate with the injured environment to minimize inflammation and/or prevent/minimize infection. Determine optimal biomaterial and its structure/function that will result in regeneration of functional, complex tissue (at least 1 cubic centimeter) in vitro with intrinsic properties representative of the native tissue.

PHASE II:  Test the efficacy of the biomaterials in small animal model with an injury model representative of the complex tissue injury/loss. Assess the biomaterial for its ability for regeneration and re-integration with surrounding tissue and functional outcome. Establish performance parameters of the biomaterials for the injury model. Assess the safety. Optimize the parameters and develop plans for large animal, pre-clinical studies.

PHASE III:  Conduct large animal, pre-clinical studies based on results from phase II. The end result would be an off-the-shelf biomaterial with established performance parameters including cell types, ratio, cell solution, signaling factors, and biomaterial structure/architecture, that can be produced for human clinical studies in reconstructive surgery of repairing complex tissue injuries. It must be easy to use and should result in both aesthetic and functional outcome.

DESCRIPTION: According to a study published in the New England Journal of Medicine in 2004 (Hoge CW, Castro CA, Messer SC, et al. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. New England Journal of Medicine. 2004;351(1):13-22), it is estimated at the high-end that the prevalence of Post Traumatic Stress Disorder (PTSD) for both Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) combined is almost 20%. Although Congress has allocated $900 million for improvement in mental health care access, suicide rates have not been reduced.  These programs include outpatient treatments, hotlines and various forms of group and individual therapies including those conducted in person clinics or through the web or virtual reality. Approximately 10 to 20 percent of troops have screened positive for PTSD during redeployment (recent testimony provided by Army Brig. Gen. Loree Sutton, Director of the Defense Center of Excellence for Psychological Health and Traumatic Brain Injury, during 3 March 2009 Congressional hearing). PTSD, depression, and other mental health concerns are often difficult to diagnose due to overlapping symptoms as well as issues of stigma associated with mental illness which may cause service members to underreport psychological distress. Thus, there is a need to develop an effective, low cost, non-intrusive tool for remote monitoring/screening of the warfighter’s mental health status. 

Ideally, a non-invasive tool could be developed that determines a warfighter’s mental health status through detection of biological patterns and/or signals (e.g. identification of changes in the respondent’s biological patterns/signals based on normal conversations through the phone either with a care provider or through interactive voice response). Recent studies on PTSD, as well as past studies on other mental illnesses indicate that many mental disorders have specific speech and language processing deficits which potentially may lead themselves to detection through voice signal/pattern recognition technologies. In the case of voice signal/pattern detection, such a tool should be designed to mitigate possible answers that would throw off survey-based tools/assessments (i.e. the signal/pattern detection tool should be response/context independent). Since the military force comes from diverse backgrounds (i.e. culture, ethnic, and race), this tool needs to be applicable across various military members’ backgrounds. Clinical studies will need to be developed later for validation of this methodology.  Further, it is envisioned such a tool could be integrated into other DoD/Army funded efforts such as the Tele-TBI program and/or the FY08 SBIR "Interactive Cognitive Interface and Health Monitoring System."

PHASE I: Develop and conduct proof of concept with a demonstration of feasibility and potential efficacy.

PHASE II: Examination of the use of this technology for screening and diagnosis using a well designed, randomized controlled trial, delineating the sensitivity and specificity of the technology compared to gold standard methods of clinical diagnosis (e.g. clinical Clinician-Administered PTSD Scale (CAPS) interview). This phase should also demonstrate the capacity of this technology to assess global changes in symptoms and functioning.

PHASE III: Modeling the tool for clinical deployment. Integration of the developed tool into other DoD/Army funded efforts such as Tele-TBI program and standard clinical settings within the DOD. It is anticipated this tool could be used for remote monitoring and diagnosis of soldiers at risk for PTSD, depression, or other mental health issues including those stationed at overseas mission as well as those returning from deployments. Such a system could aid in the early identification of individuals in need of treatment.