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NASA NTRS2019

The Cognition and Fine Motor Skills Test Batteries: Normative Data and Interdependencies

Space mission success and safety relies upon astronaut functional state. Since spaceflight stressors affect cognitive processing and fine motor skills, NASA requires that measures of performance of these things remain within clinically accepted values (NASA STD 3001). NASA is in the process of developing two test batteries for the assessment of crew cognitive and fine motor skills before, during and after spaceflight. Toward that goal, the current project collected normative scores in 91 “astronaut-like” military and civilian pilots. The Cognition Test Battery (CTB) contains ten sub-tests that measure a range of cognitive abilities. For five of the ten CTB sub-tests, we propose scores to improve the battery’s sensitivity. Among the ten sub-tests, response times were more highly correlated than accuracy scores. Principle component analysis of the correlations revealed that the first response time factor could explain over 40% of the total variance and appeared to represent the tendency of observers to try to respond more quickly. The first accuracy factor (explaining only 20%) gave a high weight to the higher level cognitive sub-tests and a negative weight to tasks associated with motor and lower level cognitive processing. The Fine Motor Skills (FMS) test battery contains four sub-tests (Tracking, Pointing, Tracing, Rotating) performed on an Apple iPad tablet computer. Principle component analysis on the sub-test response time correlations revealed that the first two factors accounted for ~80% of the variance in performance. The first component captured overall speed on all four of the sub-tests. The second factor separated the sub-tasks into two groups (Drag-Point vs Trace-Rotate). Previous work found the first group response times correlated with that of a standard peg board task, while those of the other group did not. Correlations were computed between the first FMS factor and the response time and accuracy scores from each CTB sub-task. Performing fine motor behaviors rapidly was significantly correlated with the ability to perform many of the CTB sub-tests rapidly. This ability cannot be simple motor speed since scores on the Psychomotor Vigilance Test (PVT) subtask did not correlate with the ability to perform the other tasks rapidly. Speed on fine motor skills correlated significantly with accuracy on the short-term-memory sub-test. We hypothesize that eye movements, which can be regarded as a fine motor skill, may explain this relationship.

cognition↗
NASA NTRS2012

Paramyxovirus Infection Mimics In Vivo Cellular Dynamics in Three-Demensional Human Bronchio-Epithelial Tissue-Like Assemblies

Respiratory syncytial virus and parainfluenza virus cause severe respiratory disease, especially in infants, children and the elderly. An in vitro model that accurately mimics infection of the human respiratory epithelium (HRE) would facilitate vaccine development greatly. Monolayer cultures traditionally used to study these viruses do not accurately and precisely differentiate the replication efficiencies of wild type and attenuated viruses. Therefore, we engineered novel three-dimensional (3D) tissue-like assemblies (TLAs) of human broncho-epithelial (HBE) cells to produce a more physiologically relevant in vitro model of the HRE. TLAs resemble HRE structurally and by expression of differentiated epithelial cell markers. Most significantly, wild type viruses exhibited a clear growth advantage over attenuated strains in TLAs unlike monolayer cultures. In addition, the TLAs responded to virus infection by secreting pro-inflammatory mediators similar to the respiratory epithelia of infected children. These characteristics make the TLA model a valuable platform technology to develop and evaluate live, attenuated respiratory virus vaccine candidates for human use. Respiratory virus diseases, the most frequent and least preventable of all infectious diseases, range in severity from the common cold to severe bronchiolitis and pneumonia . Two paramyxoviruses, respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3), are responsible for a majority of the most severe respiratory diseases of infants and young children. RSV causes 70% of all bronchiolitis cases and is a major cause of morbidity and mortality worldwide, especially in infants. PIV3 causes 10-15% of bronchiolitis and pneumonia during infancy, second only to RSV, and 40% of croup in infants To date, licensed vaccines are not available to prevent these respiratory diseases. At present, traditional monkey kidney (Vero and LLC-MK2) and human (HEp-2) tissue culture cells and small animal models (mouse, cotton rat, guinea pig, ferret, and hamster) fail to accurately imitate viral replication and human disease states (8). Lacking an authentic model has impeded the development and evaluation of live, attenuated vaccine candidates. Development of a physiologically relevant in vitro tissue culture model that reproduces characteristics of the HRE, the primary target of RSV and PIV3, would aid in predicting clinical attenuation and safety of vaccine candidates. Successful tissue engineering of a 3D human intestinal model using novel NASA technology inspired the development of a tri-culture 3D model for the HRE. Sequential layering of primary mesenchymal cells (comprised of normal human fibroblasts and endothelial cells) followed by BEAS-2B epithelial cells derived from human bronchi and tracheae were recapitulated on Cultisphere and/or cytodex3 microcarriers in cylindrical vessels that rotate horizontally creating an organized epithelial structure. Horizontal rotation randomizes the gravity vector modeling aspects of microgravity. Mesenchymal and epithelial cells grown under these conditions reproduce the structural organization, multi-cellular complexity, and differentiation state of the HRE. The opportunity to study respiratory viruses in a nasal epithelium model is invaluable because the most promising respiratory virus vaccine candidates are live attenuated viruses for intranasal administration. Here we characterize the interactions of respiratory viruses and epithelial cells grown under modeled microgravity in comparison to gravity-ladened monolayers. 3D HBE TLAs and traditional monolayers (2D) are infected at 35 C, the upper temperature of the upper HRE, to simulate in vivo infection conditions. Growth kinetics of wild type (wt) RSV and PIV3 viruses were compared in 2D and 3D cells to that of strains attenuated in humans or rhesus macaques. This novel 3D HBE model also offers an opportunity to study whether the epithelial cell function, especially in host defenses recapitulated by mimicking the structural organization of the HRE. In vivo, airway epithelial cells play a significant and dynamic role in host defense by blocking paracellular permeability and modulating airway function through cellular interactions or tight junctions. As regulators of the innate immune response, epithelial cells constitutively express cytokines, chemokines, and colony stimulating factors including RANTES, IL-8, IL-6, GM-CSF, and G-CSF for proactive host defense. In response to viral infection, epithelial cells induce potent immuno-modulatory and pro-inflammatory cytokines that recruit phagocytic and inflammatory cells to clear the virus and enhance protection. Although disease pathogenesis is classically attributed to the cytopathic effects of the pathogen, severe disease states associated with RSV and PIV3 are attributed to the inflammatory response, especially in infants. RSV is a potent inducer of cytokines and pro-inflammatory mediators in epithelial cells in vivo. A differentiated human epithelial model independent of the complete functional immune system will help elucidate the role of epithelial cells in respiratory disease. We reported here, virus and host cell interactions in 3D HBE TLAs are similar to that in vivo. Because the epithelial cell organization of the TLAs impacts not only the expression of airway epithelial characteristics, but also cellular communication, the TLAs represent a more physiologically relevant model of the HRE than BEAS-2B or other non-tumour monolayer models of respiratory disease. As a result, wild type respiratory viruses have a clear growth advantage over attenuated viruses in TLAs unlike traditional monolayers. In addition, the TLAs respond to wild type virus infection by secreting pro-inflammatory mediators characteristic of infected HRE. TLAs expressing microbial defense mechanisms provide an excellent model to study the interactions of respiratory pathogens with their host and to identify the innate immunity mediators. Therefore, 3D HBE TLAs offer advantages for the study of respiratory viruses and the development of viral vaccine candidates.

Deatly, Anne M.↗
NASA NTRS1997

Space Biosensor Systems: Implications for Technology Transfer

To meet the need for continuous, automated monitoring of animal subjects, including; humans, during space flight, NASA is developing advanced physiologic sensor and biotelemetry system technologies. The ability to continuously track basic physiological parameters, such as heart rate, blood pH, and body temperature, in untethered subjects in space is a challenging task. At NASA's Ames Research Center, where a key focus is gravitational biology research, engineers have teamed with life scientists to develop wireless sensor systems for automated physiologic monitoring of animal models as small as the rat. This technology is also being adapted, in collaboration with medical professionals, to meet human clinical monitoring needs both in space and on the ground. Thus, these advanced monitoring technologies have important dual-use functions; they meet space flight data collection requirements and constraints, while concurrently addressing a number of monitoring and data acquisition challenges on the ground in areas of clinical monitoring and biomedical research. Additional applications for these and related technologies are being sought and additional partnerships established that enhance development efforts, reduce costs and facilitate technology infusion between the public and private sectors. This paper describes technology transfer and co-development projects that have evolved out of NASA's miniaturized, implantable chemical sensor development efforts.

Hines, J. W.↗
NASA NTRSDate not supplied

Clinical Trials at NASA: What Makes A Clinical Trial & What Are the Requirements for International Partners?

ClinicalTrials.gov is a public registry designed to fulfill ethical obligations by providing information about clinical research studies to the general public, patients, medical practitioners and the research community. In the United States, recent revisions to human subject’s regulations have prompted new criteria for what constitutes a clinical trial along with requirements not typically requested for other types of human subject’s research. Identification of investigational clinical trials is the shared responsibility of NASA, the IRB, and the scientific investigators designing and conducting the research. This talk aims to educate attendees on the history of the development of Clinicaltrials.gov, discussion of why these requirements are important to both participants and researchers, and information on how to identify clinical trials research. In addition, we will provide information on the different requirements for clinical trials conducted at NASA or aboard the International Space Station.

Clinicaltrials.gov↗
NASA NTRS2023

Progressively Enabling Earth Independent Medical Operations (EIMO)

This panel presents the findings from a series of Technical Interchange Meetings (TIMs) hosted by the Exploration Medical Capability Element (ExMC) in NASA’s Human Research Program. The topics for the TIMs were derived from a 2-day conference of senior leaders and subject matters experts that collectively outlined a multi-faceted strategy designed to optimize crew health and performance through an increasingly autonomous medical approach. The first abstract in this panel outlines the scope of issues related to data collection, usage, transmission and computing capacity to facilitate EIMO. The second presentation provides an overview of the challenges in developing curricula and advanced training tools to baseline knowledge, skills and abilities (KSA), verify clinical competency and assure retention during prolonged durations inherent in exploration-class missions. An overview of the complicated medical supply and resource chain necessary to facilitate EIMO is provided in the third presentation of this panel. The final presentation in this EIMO panel surveys the breadth and depth of demands on cognitive load expected to be experienced by crew on an exploration mission and proposes strategies to mitigate the prospect of cognitive overload through methods to shift task load from the crew to multi-modal artificial intelligence based medical support systems. Taken together, these presentations summarize the challenges to be expected and potential solution spaces to be explored and developed to progressively enable increasing autonomous medical operations to support crewed missions beyond low earth orbit. Through EIMO focused pre-mission planning, integrated data architecture design, innovative training development and AI-assisted task load management, the gradual transition of medical care and decision making from terrestrial to space-based assets enabling support of astronaut health and performance and reducing overall mission risk is achievable.

Jay Lemery↗
NASA NTRSDate not supplied

Progressively Enabling Earth Independent Medical Operations (EIMO)

This panel presents the findings from a series of Technical Interchange Meetings (TIMs) hosted by the Exploration Medical Capability Element (ExMC) in NASA’s Human Research Program. The topics for the TIMs were derived from a 2-day conference of senior leaders and subject matters experts that collectively outlined a multi-faceted strategy designed to optimize crew health and performance through an increasingly autonomous medical approach. The first abstract in this panel outlines the scope of issues related to data collection, usage, transmission and computing capacity to facilitate EIMO. The second presentation provides an overview of the challenges in developing curricula and advanced training tools to baseline knowledge, skills and abilities (KSA), verify clinical competency and assure retention during prolonged durations inherent in exploration-class missions. An overview of the complicated medical supply and resource chain necessary to facilitate EIMO is provided in the third presentation of this panel. The final presentation in this EIMO panel surveys the breadth and depth of demands on cognitive load expected to be experienced by crew on an exploration mission and proposes strategies to mitigate the prospect of cognitive overload through methods to shift task load from the crew to multi-modal artificial intelligence based medical support systems. Taken together, these presentations summarize the challenges to be expected and potential solution spaces to be explored and developed to progressively enable increasing autonomous medical operations to support crewed missions beyond low earth orbit. Through EIMO focused pre-mission planning, integrated data architecture design, innovative training development and AI-assisted task load management, the gradual transition of medical care and decision making from terrestrial to space-based assets enabling support of astronaut health and performance and reducing overall mission risk is achievable.

John Lemery↗
NASA NTRS1976

Automated electroencephalography system and electroencephalographic coordinates of space motion sickness, part 1

A self-contained and portable device which permits clinical electroencephalography (EEG) to be conducted in remote locations by minimally trained, nontechnical personnel was developed and tested. The unit accomplishes semiautomatic acquisition of EEG data from the patient, simultaneous transmission of eight data channels to a central hospital facility over conventional telephone equipment, and automatic printing (at the remote site) of the EEG report generated at the central location. Consequently, this system enables the delivery of high-quality EEG diagnostic services in a geographically remote site with the accuracy and speed formerly possible only in certain large medical centers. Beside obvious potential clinical applications, this system serves as an initial prototype of a unit which could provide inflight EEG during future space missions.

Frost, J. D., Jr.↗
NASA NTRS2004

Microminiature Monitor for Vital Electrolyte and Metabolite Levels of Astronauts

Ions, such as proton (pH) and potassium, play a crucial role in body fluids to maintain proper basic functioning of cells and tissues. Metabolites, such as glucose, control the energy available to the entire human body in normal as well as stress situations, and before, during, and after meals. These molecules diffuse easily between blood in the capillaries and the interstitial fluid residing between cells and tissues. We have developed and approach to monitoring of critical ions (called electrolytes) and glucose in the interstitial fluid under the human skin. Proton and potassium levels sensed using optode technology that translates the respective ionic concentrations into variable colors of corresponding ionophore/dye/polymeric liquid membranes. Glucose is monitored indirectly, by coupling through immobilized glucose oxidase with local pH that is then detected using a similar color scheme. The monitor consists of a tiny plastic bar, 100-200 microns wide and 1-2 mm long, placed just under the skin, with color changing spots for each analyte as well as blanks. The colors are read and translated into concentration values by a CCD camera. Direct optical coupling between the in vivo sensing bar and the ex vivo detector device requires no power, and thus eliminates the need for wires or optical fibers crossing the skin. The microminiature bar penetrates the skin easily and painlessly, so that astronauts could insert it themselves. The approach is fully compatible with telemetry in space, and thus, in vivo clinical data will be available real time in the Earth based command center once the device is fully developed. The information provided can be used for collecting hitherto unavailable vital data on clinical effects of space travel. Managing clinical emergencies in space with the sensor already in place should also become much more efficient than without a continuous monitor, as is currently the case. Civilian applications may include better glucose control of patients with moderate to severe diabetes: a growing health problem in the US and World-wide.

Tohda, Koji↗
NASA NTRS1975

An approach to high speed ship ride quality simulation

The high speeds attained by certain advanced surface ships result in a spectrum of motion which is higher in frequency than that of conventional ships. This fact along with the inclusion of advanced ride control features in the design of these ships resulted in an increased awareness of the need for ride criteria. Such criteria can be developed using data from actual ship operations in varied sea states or from clinical laboratory experiments. A third approach is to simulate ship conditions using measured or calculated ship motion data. Recent simulations have used data derived from a math model of Surface Effect Ship (SES) motion. The model in turn is based on equations of motion which have been refined with data from scale models and SES of up to 101 600-kg (100-ton) displacement. Employment of broad band motion emphasizes the use of the simulators as a design tool to evaluate a given ship configuration in several operational situations and also serves to provide data as to the overall effect of a given motion on crew performance and physiological status.

Malone, W. L.↗
NASA NTRS1979

Continuous sterilization of plumbing systems

Continuous sterilization of plumbing, such as in hospitals, clinics, and biological testing laboratories is possible with ethylene oxide/Freon 12 (ETO/F-12) humidifier developed for sterilization of potable water systems.

Bryan, C. J.↗
NASA NTRS1998

Sit Up Straight

BioMetric Systems has an exclusive license to the Posture Video Analysis Tool (PVAT) developed at Johnson Space Center. PVAT uses videos from Space Shuttle flights to identify limiting posture and other human factors in the workplace that could be limiting. The software also provides data that recommends appropriate postures for certain tasks and safe duration for potentially harmful positions. BioMetric Systems has further developed PVAT for use by hospitals, physical rehabilitation facilities, insurance companies, sports medicine clinics, oil companies, manufacturers, and the military.

Source record↗
NASA NTRS2001

Radiation induces genomic instability and mammary ductal dysplasia in Atm heterozygous mice

Ataxia-telangiectasia (AT) is a genetic syndrome resulting from the inheritance of two defective copies of the ATM gene that includes among its stigmata radiosensitivity and cancer susceptibility. Epidemiological studies have demonstrated that although women with a single defective copy of ATM (AT heterozygotes) appear clinically normal, they may never the less have an increased relative risk of developing breast cancer. Whether they are at increased risk for radiation-induced breast cancer from medical exposures to ionizing radiation is unknown. We have used a murine model of AT to investigate the effect of a single defective Atm allele, the murine homologue of ATM, on the susceptibility of mammary epithelial cells to radiation-induced transformation. Here we report that mammary epithelial cells from irradiated mice with one copy of Atm truncated in the PI-3 kinase domain were susceptible to radiation-induced genomic instability and generated a 10% incidence of dysplastic mammary ducts when transplanted into syngenic recipients, whereas cells from Atm(+/+) mice were stable and formed only normal ducts. Since radiation-induced ductal dysplasia is a precursor to mammary cancer, the results indicate that AT heterozygosity increases susceptibility to radiogenic breast cancer in this murine model system.

Non-NASA Center↗
NASA NTRS1999

Protein crystal growth and the International Space Station

Protein structural information plays a key role in understanding biological structure-function relationships and in the development of new pharmaceuticals for both chronic and infectious diseases. The Center for Macromolecular Crystallography (CMC) has devoted considerable effort studying the fundamental processes involved in macromolecular crystal growth both in a 1-g and microgravity environment. Results from experiments performed on more than 35 U.S. space shuttle flights have clearly indicated that microgravity can provide a beneficial environment for macromolecular crystal growth. This research has led to the development of a new generation of pharmaceuticals that are currently in preclinical or clinical trials for diseases such as cutaneous T-cell lymphoma, psoriasis, rheumatoid arthritis, AIDS, influenza, stroke and other cardiovascular complications. The International Space Station (ISS) provides an opportunity to have complete crystallographic capability on orbit, which was previously not possible with the space shuttle orbiter. As envisioned, the x-ray Crystallography Facility (XCF) will be a complete facility for growing protein crystals; selecting, harvesting, and mounting sample crystals for x-ray diffraction; cryo-freezing mounted crystals if necessary; performing x-ray diffraction studies; and downlinking the data for use by crystallographers on the ground. Other advantages of such a facility include crystal characterization so that iterations in the crystal growth conditions can be made, thereby optimizing the final crystals produced in a three month interval on the ISS.

STS Shuttle Project↗
NASA NTRS2011

Pharmacokinetics of Intranasal Scopolamine Gel Formation During Antiorthostatic Bedrest - A Microgravity Analog

Space Motion sickness (SMS) is an age old problem for astronauts on both short and long duration space flights. Scopolamine (SCOP) is the most frequently used drug for the treatment of motion sickness (MS) which is currently available in transdermal patch and tablet dosage forms. These formulations of SCOP are ineffective for the treatment of SMS. Intranasal dosage forms are noninvasive with rapid absorption and enhanced bioavailability thus allowing precise and reduced dosing options in addition to offering rescue and treatment options. As such, an intranasal gel dosage formulation of scopolamine (INSCOP) was developed and Pharmacokinetics (PK) and bioavailability were determined under IND guidelines. The present clinical trial compares PK and bioavailability of INSCOP in 12 normal, healthy subjects (6 male/ 6 female) during ambulation (AMB) and antiorthostatic bedrest (ABR) used as a ground-based microgravity analog. Subjects received 0.2 and 0.4 mg doses of INSCOP during AMB and ABR in a four-way crossover design. Results indicated no difference between AMB and ABR in PK parameters after 0.2 mg dose. Clearance (Cls) decreased with a concomitant increase in maximum concentration and area under concentration versus time curve (AUC) during ABR after the 0.4 mg dose. This difference in AUC and Cls at the higher but not the lower dose during ABR may suggest that ABR may affect metabolism and/or clearance at higher doses of INSCOP. These results indicate that dosing adjustment may be required for treatment of SMS with INSCOP in space.

Lakshmi, Putcha↗
NASA NTRS2011

Prescribed Travel Schedules for Fatigue Management

The NASA Fatigue Management Team is developing recommendations for managing fatigue during travel and for shift work operations, as Clinical Practice Guidelines for the Management of Circadian Desynchrony in ISS Operations. The Guidelines provide the International Space Station (ISS ) flight surgeons and other operational clinicians with evidence-based recommendations for mitigating fatigue and other factors related to sleep loss and circadian desynchronization. As much international travel is involved both before and after flight, the guidelines provide recommendations for: pre-flight training, in-flight operations, and post-flight rehabilitation. The objective of is to standardize the process by which care is provided to crewmembers, ground controllers, and other support personnel such as trainers, when overseas travel or schedule shifting is required. Proper scheduling of countermeasures - light, darkness, melatonin, diet, exercise, and medications - is the cornerstone for facilitating circadian adaptation, improving sleep, enhancing alertness, and optimizing performance. The Guidelines provide, among other things, prescribed travel schedules that outline the specific implementation of these mitigation strategies. Each travel schedule offers evidence based protocols for properly using the NASA identified countermeasures for fatigue. This presentation will describe the travel implementation schedules and how these can be used to alleviate the effects of jet lag and/or schedule shifts.

Whitmire, Alexandra↗
NASA NTRS2015

Thioaptamer Diagnostic System (TDS)

AM Biotechnologies, LLC, in partnership with Sandia National Laboratories, has developed a diagnostic device that quickly detects sampled biomarkers. The TDS quickly quantifies clinically relevant biomarkers using only microliters of a single sample. The system combines ambient-stable, long shelf-life affinity assays with handheld, microfluidic gel electrophoresis affinity assay quantification technology. The TDS is easy to use, operates in microgravity, and permits simultaneous quantification of 32 biomarkers. In Phase I of the project, the partners demonstrated that a thioaptamer assay used in the microfluidic instrument could quantify a specific biomarker in serum in the low nanomolar range. The team also identified novel affinity agents to bone-specific alkaline phosphatase (BAP) and demonstrated their ability to detect BAP with the microfluidic instrument. In Phase II, AM Biotech expanded the number of ambient affinity agents and demonstrated a TDS prototype. In the long term, the clinical version of the TDS will provide a robust, flight-tested diagnostic capability for space exploration missions.

Yang, Xianbin↗
NASA NTRS1974

Clinical applications of angiocardiography

Several tables are presented giving left ventricular (LV) data for normal patients and patients with heart disease of varied etiologies, pointing out the salient features. Graphs showing LV pressure-volume relationships (compliance) are presented and discussed. The method developed by Rackley et al. (1964) for determining left ventricular mass in man is described, and limitations to the method are discussed. Some clinical methods for determining LV oxygen consumption are briefly described, and the relation of various abnormalities of ventricular performance to coronary artery disease and ischemic heart disease is characterized.

Dodge, H. T.↗
NASA NTRS2023

Exploration Medical Capability Clinical Decision Support System Architecture Recommendation

A new era in space exploration has arrived with the goal of establishing a long-term presence on the Moon and using those learning to take the next giant leap: sending the first astronauts to Mars. These ambitious goals will require significant changes in in-flight medical care due to constraints on mass, volume, power, crew time, and medical evacuation capabilities. Furthermore, while crews currently rely on real-time communications with ground-based medical providers, as distance from Earth increases, so do communication delays and disruptions. The crew will need to autonomously detect, diagnose, treat, and prevent medical events. These constraints require development of transformative solutions and new technologies. Through participation in the Human Research Program’s (HRP) Exploration Medical Capability (ExMC) research, NASA has developed and demonstrated a Medical Data Architecture (MDA), a platform upon which a robust capability of Clinical Decision Support (CDS) can be built. As a result, NASA is now positioned to build an advanced autonomous CDS System (CDSS) which will aid in crew health decision-making. The CDSS combines data management aspects of a system that would lead to the autonomy required by NASA-STD-3001, Section 3, Health and Medical Care Standards. The project addresses the ExMC gap Medical-701: We need to increase inflight medical capabilities and identify new capabilities that (a) maximize benefit and/or (b) reduce “costs” on human system/mission/vehicle resources. This architecture recommendation document introduces an integrated data architecture that provides self-sufficient medical care for crews on long-duration spaceflight missions.

ExMC↗