OBJECTIVE: Develop a non-invasive device that either 1) prevents functional impairment due to an Acute Stress Reaction (ASR) or 2) returns Soldier to performance following the occurrence an ASR. DESCRIPTION: Mental health symptoms stemming from severe stress exposure during deployment degrade performance and compromise the safety of Soldiers and their teams in far forward operational environments. In 2018, 28% of medical evacuations were attributed to mental health-related symptoms (Armed Forces Health Surveillance Branch, 2018). Anticipated conditions of the future battlefield will increase the cognitive demands on Soldiers, and it is expected that the incidence of severe stress exposures, and thus mental health symptoms, will escalate. Soldiers will be operating in small teams for prolonged periods without ready access to tactical or medical support due to communication-interfering capabilities of adversaries and other limitations of the operational environment. These conditions will increase exposure to severely stressful situations, prolong the amount of time Soldiers must cope with severe stress reactions, and magnify the opportunity for decrements in performance to put personal safety and the mission at risk. Therefore, it might be expected that the incidence of ASR will increase. An ASR is a normal response to a severe physical or mental stressor, such as combat, that results in maladaptive emotional, cognitive, somatic, and/or behavioral symptoms during the first 1-3 days following a traumatic event. Unfortunately, there are currently no FDA-approved treatments for ASR. Further, existing treatments for trauma-related disorders such as PTSD have limited efficacy in Soldiers and take 4-6 weeks to reach effects. It is therefore critical to develop safe and effective interventions to support Soldier performance prior to, during, and after severe stress exposure during combat operations. Additionally, treatments for ASR should not result in significant cognitive, motor or other functional side effects, act rapidly to sustain Soldier performance, and be safely administered in operational environments as part of pre-hospital care. This STTR aims to develop a non-invasive device that could be used in training prior to, during, or immediately following a traumatic stress exposure to maintain Soldier performance in an operational environment. The deliverable must function in a range of environments (e.g., laboratory, operational training, in garrison, and far forward deployment settings) where smartphone usage, service, and internet availability is variable. In the context of multi-domain operations, internet, electronic, or blue tooth connectivity will not be likely. PHASE I: Phase I will focus on development of performance parameters and initial concept testing for a prototype device. Performer should develop a plan for a practical deployment, use of the prototype in different environments (e.g., in lab, in garrison, training, deployed settings) where there is variable access to electronic or internet connectivity. Primary performance parameters to be considered for devices that will be utilized as preventative treatments include level of efficacy in maintaining baseline performance, preventing the occurrence of stress-related symptoms, training time needed, ease of use, retention time of treatment effects, impact on functional performance, portability, maintenance requirements and network requirements. Performance parameters to be considered for devices that will be utilized as pre-hospital treatments include level of efficacy in restoring performance and/or reducing stress-related symptoms, time to reach treatment effects, FDA market authorization (if applicable), ease of use, retention time of treatment effects, impact on functional performance, portability, maintenance requirements, network requirements, production costs, and maintenance costs. Finally, this phase will produce a virtual or in-person demonstration of device function based on established performance parameters. PHASE II: Phase II will focus on creating a field-testable prototype that meets the criteria determined in Phase I. The aim will be to demonstrate proof-of-concept by developing, testing, and refining a prototype. In order to accomplish this Phase II testing and evaluation, the objectives for human subject research for testing and data acquisition must be defined. A research protocol aimed at validating the prototype in a laboratory setting should evaluate the capabilities of the prototype through limited human testing in laboratory research. The laboratory testing should demonstrate that the device is able to 1) effectively prevent decrements in performance on operationally relevant tasks or increased stress symptoms following training and stressor administration in a laboratory setting or 2) effectively restore performance on operationally relevant tasks or stress symptoms following stressor administration in a laboratory setting. During this phase, the stressor administration does not need to be a traumatic stressor, but can utilize a well-validated model of human laboratory stress. The stress and measures of performance should be as operationally relevant and translatable to military stress and operational performance as are feasible. A regulatory strategy should be put in place if applicable, including a pre-submission meeting with the FDA to assist with protocol design. PHASE III DUAL USE APPLICATIONS: Phase III will focus on refinement of the device prototype, based on evaluation data obtained in Phase II, in order to create a final production-ready system. The full functionality of this final device will be evaluated within an operational field environment. For devices that will be utilized as preventative treatments, effectiveness will be evaluated using baseline performance metrics gathered prior to training with the device and an appropriate comparison group may be determined based on device specifications and with input from the FDA. For devices that will be utilized as pre-hospital treatments, effectiveness will be evaluated using an appropriate comparator based on the device specifications and with input from the FDA, as appropriate. The vision for this capability is to have a device that can be used during pre-deployment training to prevent an ASR or for pre-hospital treatment of ASRs during combat. Defense R&D funding may be obtained in coordination with an advanced developer, such as US Army Medical and Materiel Development Activity (USAMMDA) Warfighter Brain Health Project Management Office, to expedite the technology transition from the laboratory to operational use. As applicable, the company will develop a quality management system and regulatory strategy for FDA marketing application submission. This effort will deliver a product that is broadly usable by the DoD for prevention or treatment of ASR. The final product should be presented to applicable DoD representatives and program managers for transition to use in military environments. Further, the utility of this a non-invasive device may be relevant to industry, academia, and the general public for the potential treatment of other trauma-related disorders, pending additional FDA marketing authorizations. Awardees must outline a commercialization pathway including, but not limited to, regulatory strategy, marketing strategy, consumer feedback, and sales. REFERENCES: 1. Armed, Forces Health Surveillance Branch. "Update: Medical evacuations, active and reserve components, US Armed Forces, 2017." MSMR 25.7 (2018): 17 KEYWORDS: Traumatic stress, neuromodulation, neurofeedback, acute stress reaction, acute stress disorder
