A Closed-Loop Sense/Assess/Augment Wearable Device for Autonomous Performance Enhancement

TECH FOCUS AREAS: Biotechnology Space TECHNOLOGY AREAS: Bio Medical; Sensors OBJECTIVE: This topic seeks to develop a closed-loop wearable system to continuously measure a subject's performance indicators, identify performance decay episodes, and deliver, in a controlled and automated manner, enhancement agents to return the subject's performance to optimal levels. DESCRIPTION: Missions in remote locations, including U.S. Africa Command (AFRICOM), require service members to operate with minimal on-site support for extended durations. Operations in these locations often demand that go or no-go decisions be made with limited situational awareness regarding the risks to service members. Emerging technologies that enable assessment of their physical and mental state can greatly inform upon those decisions, leading to better command and control (C2) decision-making that reduces the potential for loss of life and mission failure, as recommended in the Air Force S&T 2030 strategy, demands on combat decision-makers are outstripping the cognitive capacity of the unaided human . Moreover, technologies capable of automated assessment can augment force readiness with minimum embedded medical support. A significant body of work has been devoted to the design of systems to monitor neurochemicals in the brain for closed-loop neuromodulation to address conditions including Parkinson's disease and other medical conditions. Along the same lines, the concept of an artificial pancreas is based on the availability of the continuous glucose monitoring and the ability to use its data to control the delivery of insulin through an external pump. Less attention has been placed on closed-loop systems for non-medical conditions, including stress and fatigue, which critically affect performance in the field. Recent work has demonstrated that electrochemical aptamer-based sensors can be used for feedback-controlled drug delivery of an antibiotic, providing an opportunity to expand the development of these closed-loop systems to other molecular targets using a variety of sensor architectures. The aim of this topic is to demonstrate new capabilities in the bio medical and sensors technology areas consisting of a wearable sensor that can monitor personalized performance indicators. The sensor should assess the information and autonomously initiate delivery of the performance enhancement agent(s) when performance decay is detected, until the metrics evaluated return to pre-intervention values. This technology will provide capabilities to restore service members operating in austere environments back to full capacity, addressing needs in the focus area of biotechnology. PHASE I: Phase I firms will perform a literature search to determine the ideal prototype architecture to demonstrate a closed-loop sense/assess/augment capability and identify the appropriate molecular performance biomarkers to be monitored by the device and the enhancement agents to be delivered. Based on these studies, develop a product development project plan adapting existing technology as much as possible or developing a new platform, if necessary. Efforts will define a use case, expected benefits, development milestones, and schedule for a Phase II prototype, as well as identifying key risk areas and associated mitigations. Performers will engage with and support USAF sponsors and partners to develop concepts of operation. PHASE II: Companies selected for Phase II will execute the plan designed in Phase I. Development should include validation of performance in a representative environment for both intermediate and final system prototype deliverables. Efforts will demonstrate the performance of final prototype system by measuring stress-related biomarkers, assessing a subject's stress levels based on biomarkers and delivering enhancement chemicals when stress adversely affects performance in a realistic or actual environment of intended use. User interface functionality will be demonstrated, and an integration pathway defined to make data available for decision actions. This will require engagement with USAF sponsor and end-user representatives to guide development and test and evaluation strategy. PHASE III DUAL USE APPLICATIONS: The artificial pancreas is a recent product realizing the concept of a closed-loop system for a non-neuromodulation application. Recent advances in Academia have demonstrated it is possible to expand these capabilities beyond glucose/insulin. The performer could look into the medical field for dual-use opportunities for the closed-loop sensors to be developed. For instance, these types of systems could be applied to the care of patients in emergency units by providing pain medicine as well as antibiotics, only when needed and until the patient does not need this intervention any longer, which would dramatically decrease the workload of first responders and care professionals. REFERENCES: Mirza, Golden, Nikolic, Toumazou. Closed-Loop Implantable Therapeutic Neuromodulation Systems Based on Neurochemical Monitoring. 2019, 13, Article 808; Bouthour, M gevand, Donoghue, L scher, Birbaumer, Krack. Biomarkers for closed-loop deep brain stimulation in Parkinson disease and beyond. Nature Reviews NeuRology, 2019, 15, 343; Li, Liang, Laken, Langer, Traverso. Clinical Opportunities for Continuous Biosensing and Closed-Loop Therapies. Trends in Chemistry, 2020, 2, 4, 319-340; Dauphin-Ducharme, Yang, Arroyo-Curr s, Ploense, Zhang, Gerson, Kurnik, Kippin, Stojanovic, Plaxco. Electrochemical Aptamer-Based Sensors for Improved Therapeutic Drug Monitoring and High-Precision, Feedback-Controlled Drug Delivery. ACS Sens. 2019, 4, 2832-2837 KEYWORDS: closed-loop system; drug delivery; sensors; stress; performance recovery