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NASA NTRS2001

Artificial gravity: head movements during short-radius centrifugation

Short-radius centrifugation is a potential countermeasure to long-term weightlessness. Unfortunately, head movements in a rotating environment induce serious discomfort, non-compensatory vestibulo-ocular reflexes, and subjective illusions of body tilt. In two experiments we investigated the effects of pitch and yaw head movements in participants placed supine on a rotating bed with their head at the center of rotation, feet at the rim. The vast majority of participants experienced motion sickness, inappropriate vertical nystagmus and illusory tilt and roll as predicted by a semicircular canal model. However, a small but significant number of the 28 participants experienced tilt in the predicted plane but in the opposite direction. Heart rate was elevated following one-second duration head turns. Significant adaptation occurred following a series of head turns in the light. Vertical nystagmus, motion sickness and illusory tilt all decreased with adaptation. Consequences for artificial gravity produced by short-radius centrifuges as a countermeasure are discussed. Grant numbers: NCC 9-58. c 2001. Elsevier Science Ltd. All rights reserved.

Non-NASA Center↗

NASA NTRS2003

Using Tri-Axial Accelerometers to Assess the Dynamic Control of Head Posture During Gait

Long duration spaceflight is known to cause a variety of biomedical stressors to the astronaut. One of the more functionally destabilizing effects of spaceflight involves microgravity-induced changes in vestibular or balance control. Balance control requires the integration of the vestibular, visual, and proprioceptive systems. In the microgravity environment, the normal gravity vector present on Earth no longer serves as a reference for the balance control system. Therefore, adaptive changes occur to the vestibular system to affect control of body orientation with altered, or non-present, gravity and/or proprioceptive inputs. Upon return to a gravity environment, the vestibular system must re-incorporate the gravity vector and gravity-induced proprioceptive inputs into the balance control regime. The result is often a period of postural instability, which may also be associated with space motion sickness (oscillopsia, nausea, and vertigo). Previous studies by the JSC Neuroscience group have found that returning astronauts often employ alterations in gait mechanics to maintain postural control during gait. It is believed that these gait alterations are meant to decrease the transfer of heel strike shock energy to the head, thus limiting the contradictory head and eye movements that lead to gait instability and motion sickness symptoms. We analyzed pre- and post-spaceflight tri-axial accelerometer data from the NASA/MIR long duration spaceflight missions to assess the heel to head transfer of heel strike shock energy during locomotion. Up to seven gait sessions (three preflight, four postflight) of head and shank (lower leg) accelerometer data was previously collected from six astronauts who engaged in space flights of four to six months duration. In our analysis, the heel to head transmission of shock energy was compared using peak vertical acceleration (a), peak jerk (j) ratio, and relative kinetic energy (a). A host of generalized movement variables was produced in an effort to isolate those that best highlighted vestibular adaptation due to spaceflight. Data suggest that astronauts used either head or body centered control to reduce the effects of heel strike shock on head position during normal walking at self-selected speeds. Moreover, the form of that control appears to fall under one of two categories: homeostatic or adaptive. Homeostatic control refers to tight constraint (small error) over the value of a given variable before and after spaceflight with little or no adaptive changes. Adaptive control refers to lesser constraint over a given movement variable with clear adaptation to earth gravity upon return from spaceflight. Heel strike shock absorption (ratio of heel to head peak acceleration) best-discriminated head and body centered control strategies. Further, peak jerk data was useful for illustrating pre- and postflight differences in segmental (shank versus head) movement energy. Results from kinetic energy analysis show high consistency between subjects and across test dates. Whether this result highlights a control strategy or is an artifact of approximating body segments using anthropometric tables is, at this point, unclear.

Lawrence, John H., III↗

NASA NTRS2002

Effects of rotation on the sleep state-dependent midlatency auditory evoked P50 potential in the human

Sopite syndrome, characterized by loss of initiative, sensitivity to normally innocuous sensory stimuli, and impaired concentration amounting to a sensory gating deficit, is commonly associated with Space Motion Sickness (SMS). The amplitude of the P50 potential is a measure of level of arousal, and a paired-stimulus paradigm can be used to measure sensory gating. We used the rotary chair to elicit the sensory mismatch that occurs with SMS by overstimulating the vestibular apparatus. The effects of rotation on the manifestation of the P50 midlatency auditory evoked response were then assessed as a measure of arousal and distractibility. Results showed that rotation-induced motion sickness produced no change in the level of arousal but did produce a significant deficit in sensory gating, indicating that some of the attentional and cognitive deficits observed with SMS may be due to distractibility induced by decreased habituation to repetitive stimuli.

Clinical Trial↗

NASA NTRS1985

Stimulus specificity and individual stereotypy of autonomic responses to motion stressors

Motion sickness research shows a lack of agreement regarding the contribution of the autonomic nervous system (ANS). The resolution of this question is exigent for Space Adaptation Syndrome, zero gravity sickness. A case is drawn for the necessity to apply a methodological approach that incorporates: (1) standardization of parameters in relation to the individual differences in variability and prestimulus levels; (2) a concern for patterning of responses; and (3) the physiological association with subjective reports. Vasomotor, heart rate, respiration rate, skin conductance and subjective reports of malaise were collected from 22 subjects while participating in three motion stressors; vertical acceleration, Coriolis stimulation, and combined optokinetic and Coriolis stimulation. The results demonstrate that ANS response patterns can be separated into three mutually exclusive components: (1) a generalized response to motion sickness; (2) a stimulus specific response to the type of stressor being presented; and (3) individualized stereotypical response patterns that are associated with subjective reports of malaise.

Morgan, M. G.↗

NASA NTRS1993

Changes in the dark focus of accommodation associated with simulator sickness

The relationship between the dark focus of accommodation and simulator sickness, a form of motion sickness, was examined in three experiments. In Experiment 1, dark focus was measured in 18 college students in a laboratory setting before and after they viewed a projected motion scene depicting low altitude helicopter flight. In Experiments 2 and 3, dark focus was measured in pilots (N = 16 and 23, respectively) before and after they 'flew' in moving-base helicopter flight simulators with optical infinity CRT visual systems. The results showed that individuals who experienced simulator sickness had either an inward (myopic) change in dark focus (Experiments 1 and 3) or attenuated outward shifts in dark focus (Experiment 2) relative to participants who did not get sick. These results are consonant with the hypothesis that parasympathetic activity, which may be associated with simulator sickness, should result in changes in dark focus that are in a myopic direction. Night vision goggles, virtual environments, extended periods in microgravity, and heads-up displays all produce related visual symptomatology. Changes in dark focus may occur in these conditions, as well, and should be measured.

Fowlkes, Jennifer E.↗

NASA NTRS1972

Direction-specific adaptation effects acquired in a slow rotation room

Thirty-eight subjects were required to execute 120 head movements in a slow rotation room at each 1-rpm increase in velocity of the room between 0 and 6 rpm and, after a single-step gradual return to zero velocity, execute 120 head movements either immediately after the return or after delay periods varying from 1 to 24 hours unless, at any time, more than mild symptoms of motion sickness were elicited. A second stress profile differed by the sequential addition of an incremental adaptation schedule in which the direction of rotation was reversed. The experimental findings demonstrated the acquisition of direction-specific adaptation effects that underwent spontaneous decay with a short time constant (hours). Speculations are presented which could account for the simultaneous acquisition of short-term and long-term adaptation effects. The findings support the theory that motion sickness, although a consequence of vestibular stimulation, has its immediate origin in nonvestibular systems, implying a faculative or temporary linkage between the vestibular and nonvestibular systems.

Graybiel, A.↗

NASA NTRS2011

Psychophysiological Studies in Extreme Environments

This paper reviews the results from two studies that employed the methodology of multiple converging indicators (physiological measures, subjective self-reports and performance metrics) to examine individual differences in the ability of humans to adapt and function in high stress environments. The first study was a joint collaboration between researchers at the US Army Research Laboratory (ARL) and NASA Ames Research Center. Twenty-four men and women active duty soldiers volunteered as participants. Field tests were conducted in the Command and Control Vehicle (C2V), an enclosed armored vehicle, designed to support both stationary and on-the-move operations. This vehicle contains four computer workstations where crew members are expected to perform command decisions in the field under combat conditions. The study objectives were: 1) to determine the incidence of motion sickness in the C2V relative to interior seat orientation/position, and parked, moving and short-haul test conditions; and 2) to determine the impact of the above conditions on cognitive performance, mood, and physiology. Data collected during field tests included heart rate, respiration rate, skin temperature, and skin conductance, self-reports of mood and symptoms, and cognitive performance metrics that included seven subtests in the DELTA performance test battery. Results showed that during 4-hour operational tests over varied terrain motion sickness symptoms increased; performance degraded by at least 5 percent; and physiological response profiles of individuals were categorized based on good and poor cognitive performance. No differences were observed relative to seating orientation or position.

Toscano, William B.↗

NASA NTRS1977

Labyrinth and cerebral-spinal fluid pressure changes in guinea pigs and monkeys during simulated zero G

This study was undertaken to explore the hypothesis that shifts of body fluids from the legs and torso toward the head contribute to the motion sickness experienced by astronauts and cosmonauts. The shifts in body fluids observed during zero-G exposure were simulated by elevating guinea pigs' and monkeys' torsos and hindquarters. Cerebral-spinal fluid pressure was recorded from a transducer located in a brain ventricle; labyrinth fluid pressure was recorded from a pipette cemented in a hole in a semicircular canal. An anticipated divergence in cerebral-spinal fluid pressure and labyrinth fluid pressure during torso elevation was not observed. The results of this study do not support a fluid shift mechanism of zero-G-induced motion sickness. However, a more complete test of the fluid shift mechanism would be obtained if endolymph and perilymph pressure changes were determined separately; we have been unable to perform this test to date.

Parker, D. E.↗

NASA NTRS1985

Canadian medical experiments on Shuttle Flight 41-G

During the 41-G mission, two payload specialist astronauts took part in six Canadian medical experiments designed to measure how the human nervous system adapts to weightlessness, and how this might contribute to space motion sickness. Similar tests conducted pre-flight provided base-line data, and post-flight experiments examined re-adaptation to the ground. No changes were detected in the vestibulo-ocular reflex during this 8-day mission. Pronounced proprioceptive illusions were experienced, especially immediately post-flight. Tactile acuity was normal in the fingers and toes, but the ability to judge limb position was degraded. Estimates of the locations of familiar targets were grossly distorted in the absence of vision. There were no differences in taste thresholds or olfaction. Despite pre-flight tests showing unusual susceptibility to motion sickness, the Canadian payload specialist turned out to be less susceptible than normal on-orbit. Re-adaptation to the normal gravity environment occurred within the first day after landing.

Watt, D. G. D.↗

NASA NTRS1999

Visual-vestibular integration motion perception reporting

Self-orientation and self/surround-motion perception derive from a multimodal sensory process that integrates information from the eyes, vestibular apparatus, proprioceptive and somatosensory receptors. Results from short and long duration spaceflight investigations indicate that: (1) perceptual and sensorimotor function was disrupted during the initial exposure to microgravity and gradually improved over hours to days (individuals adapt), (2) the presence and/or absence of information from different sensory modalities differentially affected the perception of orientation, self-motion and surround-motion, (3) perceptual and sensorimotor function was initially disrupted upon return to Earth-normal gravity and gradually recovered to preflight levels (individuals readapt), and (4) the longer the exposure to microgravity, the more complete the adaptation, the more profound the postflight disturbances, and the longer the recovery period to preflight levels. While much has been learned about perceptual and sensorimotor reactions and adaptation to microgravity, there is much remaining to be learned about the mechanisms underlying the adaptive changes, and about how intersensory interactions affect perceptual and sensorimotor function during voluntary movements. During space flight, SMS and perceptual disturbances have led to reductions in performance efficiency and sense of well-being. During entry and immediately after landing, such disturbances could have a serious impact on the ability of the commander to land the Orbiter and on the ability of all crew members to egress from the Orbiter, particularly in a non-nominal condition or following extended stays in microgravity. An understanding of spatial orientation and motion perception is essential for developing countermeasures for Space Motion Sickness (SMS) and perceptual disturbances during spaceflight and upon return to Earth. Countermeasures for optimal performance in flight and a successful return to Earth require the development of preflight and in-flight training to help astronauts acquire and maintain a dual adaptive state. Despite the considerable experience with, and use of, an extensive set of countermeasures in the Russian space program, SMS and perceptual disturbances remain an unresolved problem on long-term flights. Reliable, valid perceptual reports are required to develop and refine stimulus rearrangements presented in the PAT devices currently being developed as countermeasures for the prevention of motion sickness and perceptual disturbances during spaceflight, and to ensure a less hazardous return to Earth. Prior to STS-8, crew member descriptions of their perceptual experiences were, at best, anecdotal. Crew members were not schooled in the physiology or psychology of sensory perception, nor were they exposed to the appropriate professional vocabulary. However, beginning with the STS-8 Shuttle flight, a serious effort was initiated to teach astronauts a systematic method to classify and quantify their perceptual responses in space, during entry, and after flight. Understanding, categorizing, and characterizing perceptual responses to spaceflight has been greatly enhanced by implementation of that training system.

Harm, Deborah L.↗

NASA NTRS2007

Medical Monitoring during Short Radius Centrifugation in Bed-rested Subjects

The artificial gravity pilot project was designed to investigate the efficacy of daily exposure to a Gz acceleration gradient for counteracting the physiologic decrements induced by prolonged bed rest. A short radius centrifuge was used to produce a Gz gradient such that 1 g was applied at the level of the subject s heart and 2.5 g at the feet. For inclusion in the study, subjects were required to complete a 75-minute screening spin on the centrifuge. During the study, each active treatment subject was scheduled for a 60-minute spin each day for 20 consecutive days. During centrifugation, subjects were continuously monitored by a physician for signs and symptoms of pre-syncope, motion sickness, arrhythmias, joint/muscle pain and any other unanticipated problems. The physician was also present to provide emergency care in the case of a medical emergency. Cameras mounted on the centrifuge were used to provide a means of observing the subject s face and torso. Audio communication was continuously maintained. Other monitoring tools included two-lead EKG tracings, pulse oximetry, intermittent sphygmomanometer readings, lights in the peripheral visual field, and continuous blood pressure readout from a tonometry device. Thirty screening runs were attempted using twenty-seven subjects. Seven of these runs were terminated early for symptoms of pre-syncope, motion sickness, or GI distress. A total of eight subjects completed the active treatment arm of the study. Of the 160 centrifuge runs that were scheduled for these eight treatment subjects, 152 were completed, seven were terminated early, and one was not attempted. Of the seven early terminations, four were related to symptoms of pre-syncope, one to leg pain, one to GI discomfort, and one to equipment failure. Three terminations for adverse symptoms occurred on the first treatment day. Three terminations occurred on day nineteen of treatment and within 24 hours after scheduled soleus and quadriceps muscle biopsies. We have summarized the relative usefulness of the information obtained by the various monitoring modalities in making a decision to terminate a centrifuge run. The video and audio communication information was essential to the decision-making process. Heart rate and EKG tracings are considered valuable, even though no spins were terminated due to significant arrhythmias. The tonometer device was generally not reliable in this application. Our observations suggest that subjects may be less tolerant of centrifugation just after starting bed rest and after invasive procedures.

Reinertson, Randal↗

NASA NTRS1988

Vestibular reflexes of otolith origin

The vestibular system and its role in the maintenance of posture and in motion sickness is investigated using cats as experimental subjects. The assumption is that better understanding of the physiology of vestibular pathways is not only of intrinsic value, but will help to explain and eventually alleviate the disturbances caused by vestibular malfunction, or by exposure to an unusual environment such as space. The first project deals with the influence on the spinal cord of stimulation of the vestibular labyrinth, particularly the otoliths. A second was concerned with the properties and neural basis of the tonic neck reflex. These two projects are related, because vestibulospinal and tonic neck reflexes interact in the maintenance of normal posture. The third project began with an interest in mechanisms of motion sickness, and eventually shifted to a study of central control of respiratory muscles involved in vomiting.

Wilson, Victor J.↗

NASA NTRS1999

Effects of Command and Control Vehicle (C2V) Operational Environment on Soldier Health and Performance

The purpose of this project was to use NASA technology to assist the US Army in the assessment of motion sickness and performance of soldiers in the Command and Control Vehicle (C2V). Three different vehicle configurations were tested: oblique, (3 seats at a 20-degree angle from the direction of travel); perpendicular, (3 seats at a 90 degree angle); and 4-forward, (all seats faced forward). In all vehicles, the front seat faced forward. Sixteen men and eight women participated for 15 days: 2 days of classroom instruction; 12 days of field tests in the C2V, and 15 minutes of post-field test performance measures. Conditions for field tests were: an initial Park; four Moves (i.e., travel over a mixed terrain); and four Short-halts following movement. NASA task batteries, mood and symptom scales, and physiological data were collected during field tests. Motion sickness symptoms ranging from slight to severe were reported for all subjects. Conclusions were: (1) there was no difference between vehicle configurations; (2) there was a negative impact on crew performance and health when subjects attended to visual screens during vehicle movement; and (3) symptoms and performance degradation were not mitigated by intermittent short-halts.

Cowings, Patricia S.↗

NASA NTRS2005

Postural Control Disturbances Produced By Exposure to HMD and Dome Vr Systems

Two critical and unresolved human factors issues in VR systems are: 1) potential "cybersickness", a form of motion sickness which is experienced in virtual worlds, and 2) maladaptive sensorimotor performance following exposure to VR systems. Interestingly, these aftereffects are often quite similar to adaptive sensorimotor responses observed in astronauts during and/or following space flight. Most astronauts and cosmonauts experience perceptual and sensorimotor disturbances during and following space flight. All astronauts exhibit decrements in postural control following space flight. It has been suggested that training in virtual reality (VR) may be an effective countermeasure for minimizing perceptual and/or sensorimotor disturbances. People adapt to consistent, sustained alterations of sensory input such as those produced by microgravity, and experimentally-produced stimulus rearrangements (e.g., reversing prisms, magnifying lenses, flight simulators, and VR systems). Adaptation is revealed by aftereffects including perceptual disturbances and sensorimotor control disturbances. The purpose of the current study was to compare disturbances in postural control produced by dome and head-mounted virtual environment displays. Individuals recovered from motion sickness and the detrimental effects of exposure to virtual reality on postural control within one hour. Sickness severity and initial decrements in postural equilibrium decreases over days, which suggests that subjects become dual-adapted over time. These findings provide some direction for developing training schedules for VR users that facilitate adaptation, and address safety concerns about aftereffects.

Harm, D. L.↗

NASA NTRS2004

Bioavailability and Pharmacodynamics of Promethazine on Long Duration Missions to the International Space Station

Space motion sickness (SMS) is often treated in space with promethazine (PMZ). Common side effects of PMZ administration (50 mg intramuscular) on the ground are drowsiness and impaired cognitive performance. Anecdotal reports indicate that these effects are absent or less pronounced in space. This suggests that the availability of PMZ to the body (bioavailability) and/or the response of the body to PMZ (pharmacodynamics) may change during space flight. Opportunities for clinical research in space are limited. The study described here is our response to a NASA Research Announcement for proposals for flight-based research needed to improve, or answer specific questions about, diagnosis and therapy during space flight, and post-flight rehabilitation. We propose here to evaluate noninvasive methods for determining the bioavailability and pharmacodynamics of PMZ. The specific objectives of the proposed research are to 1) compare pharmacokinetic and pharmacodynamic parameters of PMZ, estimated from saliva and plasma levels after administration of PMZ, 2) estimate the relative bioavailability of the three dosage forms of PMZ that are often administered to control motion sickness symptoms in space, and 3) establish the dose-response relationship of PMZ. We will estimate the bioavailability of an intramuscular injection (IM), oral tablet, and rectal suppository of PMZ in noma1 subjects during ambulatory and antiorthostatic bed rest (ABR) conditions using novel stable isotope techniques. We will compare and contrast the bioavailability of PMZ during normal and microgravity conditions to examine changes in drug absorption and bioavailability during microgravit. Results of this study will validate methods for an approved in-flight investigation with this medication awaiting an opportunity for manifestation..

Putcha, Lakshmi↗

NASA NTRS2016

Pilot Field Test: Performance of a Sit-to-Stand Test After Long-Duration Space Flight

BACKGROUND: Astronauts returning from the International Space Station are met by a team of recovery personnel typically providing physical assistance and medical support immediately upon landing. That is because long-duration spaceflight impacts astronauts' functional abilities. Future expeditions to planets or asteroids beyond the low Earth orbit, however, may require crewmembers to egress the vehicle and perform other types of physical tasks unassisted. It is therefore important to characterize the extent and longevity of functional deficits experienced by astronauts in order to design safe exploration class missions. Pilot Field Test (PFT) experiment conducted with participation of ISS crewmembers traveling on Soyuz expeditions 34S - 41S comprised several tasks designed to study the recovery of sensorimotor abilities of astronauts during the first 24 hours after landing and beyond. METHODS: The first test in the PFT battery sequence, and also the least demanding one from the sensorimotor perspective, was a Sit-to-Stand test. Test subjects were seated in the chair and had to stand up on command and remain standing for ten seconds. The subjects were instructed to stand up unassisted as quickly as they were able to, while maintaining postural control. Synchronized wireless inertial sensors mounted on the head, chest, lower back, wrists, and ankles were used to continuously log body kinematics. Crewmembers' blood pressure and heart rate were monitored and recorded with the Portapres and Polar systems. Each session was recorded with a digital video camera. During data collections occurring within the 24-hour postflight period, crewmembers were also asked to (1) evaluate their perceived motion sickness symptoms on a 20-point scale before and after completion of the test and (2) estimate how heavy they felt compared to their normal (preflight) body weight. Consent to participate in PFT was obtained from 18 crewmembers (11 US Orbital Segment [USOS] astronauts and 7 Russian cosmonauts). For 10 subjects, the first set of data was collected in the medical tent in Soyuz landing zone (1-2 hours after landing); the other 8 subjects were tested at the Kazakhstan deployment airport (4-5 hours after landing). 8 of the 11 astronauts were tested twice more within the first 24 hours postflight, at a refueling stop on the way to Houston (approximately 13 hours after landing) and at the Johnson Space Center (approximately 24 hours after landing). Later postflight data were collected in the first two weeks on some crewmembers. Finally, 6 astronauts were tested 60+ days after landing to establish a delayed baseline. RESULTS/DISCUSSION: Two of the 18 PFT participants felt too ill to attempt any tests in Kazakhstan (at either the landing zone or deployment airport). The remaining test subjects completed the Sit-to-Stand test and their reported motion sickness scores were unaffected by this task. The task completion times and body kinematics data analysis are currently underway. Preliminary analysis of astronaut data shows a steep improvement in the time to complete the task on the second data take, and in some cases, the trend continues through day six postflight. Head and trunk pitch angles and pitch rates were also examined and increases in all measures are evident throughout the observed recovery period (60+ days postflight). Interesting patterns of head and trunk pitch coordination have also emerged. One of the data analysis objectives is comparison of initial postflight performance and recovery of experienced crewmembers and first-time fliers. Another one - possible differences in performance between USOS and Russian crewmembers.

Kofman, I. S.↗

NASA NTRS2007

Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

Das, H.↗

NASA NTRS1982

A comprehensive system model for motion/space sickness. Preliminary results

A preliminary attempt to categorize and order the observed facts regarding motion sickness into a rational structure is discussed. An array of key facts, as assembled from the recent literature, consisting of a collection of motion space sickness observations which should be accounted for in the comprehensive model are given. A model structure which is responsive to the array of key facts, as well as to the other requirements of a working research tool (modularity, ease of use, conciseness, etc.) is also suggested.

Riedel, S. A.↗