Recent field tests provide direct evidence that long duration spaceflight increases the severity of motion sickness and impairs the crewmember's balance while doing functional tasks after returning to gravity. Our project addresses the “Risk of Impaired Control of Spacecraft, Associated Systems and Immediate Vehicle Egress Due to Vestibular/Sensorimotor Alterations Associated with Spaceflight”, and includes a rehabilitation device, the Disorientation Research Device, to be built and examined for effectivity in reducing motion sickness and improving balance.
To date, we have secured a reliance agreement between NASA and Johns Hopkins University (JHU) that allows JHU to serve as the single Institutional Review Board (IRB) of record for the study. We have an approved IRB protocol to begin data collection at JHU for objective 1 (reduce motion sickness in civilians with vestibular nerve surgical ablation). We are working with Wright-Patterson Air Force Base (Dayton, OH) to secure local IRB approval to begin data collection on objective 2 (reduce motion sickness in healthy controls exposed to centrifugation using the Disorientation Research Device). We have submitted final paperwork to secure the data share agreement (Cooperative Research and. Development Agreement or "CRADA") between JHU and Wright-Patterson Air Force Base.
Both the principal investigator (Michael Schubert), two co-investigators (Americo Migliaccio and Scott Wood), and a post-doctoral fellow have met biweekly during the year to develop the motion profile we will use in attempt to reduce motion sickness and improve balance. The motion profile will task users to perform sinusoidal head rotations, matched to a metronome, about the yaw, pitch, and roll axes (90 sec epochs, 5 minutes per axis, 15 min total). The assessment for each axis consists of the number of completed epochs, with each epoch requiring head rotations of a different frequency/amplitude/velocity. Subjects are instructed to begin with an ‘easy’ amplitude (i.e., small) and increase or decrease amplitude depending on their perception of motion sickness – which is input from 0 (absent motion sickness) to 10 (vomit) using a handheld controller. Video-oculography captures eye and head velocity; it also tracks the number of blinks and saccades, metrics that can indicate worsening nausea.
Both objective 1 and 2 incorporate use of a rehabilitation device (patented) that uses video-oculography and provides auditory feedback for automated vestibular rehabilitation. The device will be innovated upon and built by the laboratory of Americo Migliaccio, in Sydney, Australia. Unfortunately, due to the outbreak of the COVID-19 Delta strain, the City of Sydney, Australia enforced a mandatory lockdown beginning June 26, 2021. In addition to the shutdown, the worldwide supply chain shortage of electronics has limited our ability to build the intended four devices. As a result, we remain at least six months behind schedule; that will impact our ability to complete objective 1 as originally intended.
As mitigation, we are working hard to build three devices (not four) using parts salvaged from prototypes. We are hopeful to have the three devices built, tested for functionality, and delivered to the U.S. within the next four months. This ten-month delay is preventing data collection for objective 1 and 2. Given the delay, we will not conduct a clinical trial at the JHU site that was to compare outcome measures between traditional vestibular rehabilitation and the novel rehabilitation device. Instead, we will conduct an observational study that examines how well the device improves performance and is adopted by the patient subjects. This mitigation is a feasible step necessary to enable useful data for both the civilian and NASA objectives within the remaining two years of the study.