Smart Polymer Reagents for Sensitivity and Speed-enhanced Clinical Diagnostics

DESCRIPTION (provided by applicant): The Detection and Alerting System for Seizure Onset (DASSO) will be a comfortable, chest-worn device that will provide continuous, wireless seizure monitoring for individuals with epilepsy. Barron Associates, a leader in the development of wireless electrocardiogram (ECG) and patient activity monitoring devices, is partnering with the University of Virginia (UVA) to develop and test the DASSO system. Problem to be Solved Rapid detection of seizure onset is important forindividuals with epilepsy, as it allows a caregiver to provide protective and/or intervening care, as needed. Failure to intervene can result in injury during attack, mental impairment or death secondary to status epilepticus, or Sudden Unexplained Death in Epilepsy (SUDEP). The problem of detecting seizure onset is complicated by the fact that there is a wide range of seizure types that present with different signs and symptoms. In the realm of continuous seizure monitoring, there remains a significant capability gap between accurate, but cumbersome, electroencephalogram (EEG) monitoring, and simple, but limited, wrist actigraphy. Phase I Summary The combination of continuous, remote heart rate (HR) and motion monitoring provides a unique capability to detect seizure onset and wirelessly alert a caregiver to provide appropriate seizure interventions. This e ort wil leverage Barron Associates' proven monitoring hardware; the primary technical challenge addressed in Phase I will be the development and testingof feature extraction and statistical change detection methodologies that exploit autonomic nervous system (ANS) activations preceding or concomitant with seizure events. Specific Aim 1 Demonstrate the feasibility of using measures of heart rate variability (HRV) to detect seizure onset for di erent seizure types. Criteria for acceptance: statistically significant seizure onset detection for non-convulsive seizures. Specific Aim 2 Demonstrate the feasibility of using HRV measures and accelerometry data jointly to detect seizures. Criteria for acceptance: improved detection specificity and detection latency for convulsive seizures versus wrist actigraphy alone. Commercial Opportunity DASSO will significantly improve the quality of life for individuals with epilepsy and their familis. Without such a monitoring device, the family and/or caregivers of individuals with epilepsy who are prone to frequent and prolonged seizures (e.g., status epilepticus) must regularly check on the patient. This is a source of stress that will be alleviated with the use of DASSO. While the low-pro le, unobtrusive device will provide greater freedom for epileptic patients and their caregivers, it could also be used for continuous physiologic monitoring for other medical conditions within this patient group, including sleep apnea and cardiac arrhythmias. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: DASSO will remotely and wirelessly monitor individuals with epilepsy for seizure onset via an ergonomic, chest- worn device,and alert the caregiver (via a wireless signal routed to a smartphone app) to expedite protective and/or intervening care. DASSO will be a low-cost alternative to comprehensive, but restrictive, EEG-based monitoring, while providing a broader detection capability than exists for equivalently-priced wrist-worn monitors. DASSO will significantly improve the quality of life for both individuals with epilepsy and their families by easing the stress associated with around-the-clock monitoring.