A groundbreaking clinical trial launched by Spark Biomedical in partnership with the U.S. Air Force aims to combat the deadly effects of spatial disorientation and motion sickness in military operations using innovative wearable neurostimulation technology.
The research initiative, supported by a $480,000 Defense Health Agency RESTORAL grant, will evaluate the effectiveness of transcutaneous auricular neurostimulation (tAN®) technology in military personnel. This study addresses a critical safety concern that resulted in over one hundred U.S. Air Force casualties and $2.3 billion in losses between 1993 and 2013.
Critical Need in Military Aviation
Despite rigorous training protocols, military personnel remain vulnerable to spatial disorientation – a dangerous condition where pilots lose their sense of position relative to their surroundings. Current pharmacological treatments present significant limitations in combat situations due to their sedative effects, creating an urgent need for alternative solutions.
Revolutionary Approach to Neural Stimulation
The study will utilize Spark Biomedical's Sparrow Ascent platform, which has already received FDA clearance for opioid withdrawal treatment. The technology delivers precise electrical signals through the skin near the ear, targeting the vagus and trigeminal nerves. This approach is theorized to correct the sensory misalignment that causes motion sickness and spatial disorientation.
Dr. Melanie McWade, Senior Director of Clinical Operations at Spark Biomedical, explains: "Our wearable technology has the advantage of being non-invasive and non-sedating, making it an attractive option for DoD personnel operating in dynamic environments. This study will be the first randomized controlled clinical trial assessing the use of tAN therapy to reduce the impact of motion sickness and spatial disorientation."
Trial Design and Implementation
The clinical trial, based at Joint Base San Antonio—Randolph, will involve 36 participants over a one-year period. The study design includes:
- Randomized assignment to active or sham neurostimulation groups
- Simulation of real-world conditions that trigger motion sickness
- Cognitive challenge assessments to evaluate effectiveness
- Comprehensive monitoring of spatial disorientation symptoms
Lieutenant Colonel Isaac D. Erbele, M.D., principal investigator from Brooke Army Medical Center's Otolaryngology Department, shares his optimism: "If this study is successful, and the device reduces motion sickness and spatial disorientation, we have a real opportunity to improve warfighter performance when our soldiers, airmen, and sailors find themselves in challenging environments."
Potential Impact on Military Operations
Success in this trial could revolutionize how military personnel manage motion sickness and spatial disorientation during critical operations. The non-sedating nature of tAN® therapy could provide a significant advantage over traditional treatments, potentially enhancing combat readiness and operational safety.
The study represents a crucial step forward in addressing a long-standing challenge in military aviation, with implications extending beyond military applications to potentially benefit civilian aviation and other high-risk operational environments where spatial orientation is critical.
