Lowering Economic, Infrastructure, & Physical Barriers with Noninvasive, Wireless Telemedicine Cerebrospinal Fluid Flow Sensing for Pediatric Hydrocephalus Patients in Puerto Rico

Rhaeos, Inc., Evanston IL

Investigators

Abstract

ABSTRACT Hydrocephalus, affecting over 1 million patients in the United States, is a prevalent and financially burdensome condition marked by the accumulation of cerebrospinal fluid (CSF) in the brain, presenting symptoms such as headaches, lethargy, seizures, coma, or death. It particularly afflicts children, occurring in 1-5 of every 1,000 live births. Shunt implantation, a common treatment, is marred by alarmingly high failure rates (98% over ten years), leading to frequent hospital visits and expensive diagnostic procedures. The elusive nature of non- specific symptoms like headaches and nausea compounds the difficulty in diagnosing shunt malfunction. In Puerto Rico, where access to pediatric neurosurgeons is limited to just three specialists, all based in San Juan, the timing-to-care challenge intensifies, especially for patients residing far from the medical hub. This challenge is further aggravated by Puerto Rico's higher poverty rate compared to the other 50 states. Thus, developing an affordable, accurate, and direct assessment of shunt flow technology from the comfort of one's home becomes imperative for ensuring broader accessibility across the island. Additionally, the financial burden of hydrocephalus is substantial, with approximately 125,000 shunts being implanted or replaced annually in the United States, incurring estimated costs of $2 billion per year. Addressing these challenges, our proposed project aims to introduce FlowSense, a flexible, wearable device that allows for a non-invasive, radiation-free, reliable, and fast assessment of CSF flow. This technology has the potential to significantly alleviate travel, time, and economic barriers to care by reducing the necessity and financial burden of frequent hospital visits. The specific aims for this 6 month project are as follows: Specific Aim 1: Evaluating FlowSense Utility in a Home Setting with 20 pediatric patients across Puerto Rico who will be involved in a 30 day-study. The study will incorporate video conferencing to facilitate continuous data collection, allowing for multiple measurements and comprehensive usability assessments of the FlowSense device from the comfort of the patients' homes. To achieve this, patient data will be seamlessly transmitted via a cellular network through a provided smartphone. Specific Aim 2: Development of a User-Friendly, Bilingual Smartphone Application. Here, we focus on the development of a user-friendly smartphone application, specifically tailored for Android devices. Recognizing the widespread use of Android phones and their cost-effectiveness, this application will play a pivotal role in the at-home monitoring of shunt flow. The application's primary functions include operating the FlowSense device and recording real-time data. Notably, the application will be developed in both Spanish and English, acknowledging the diverse linguistic landscape of Puerto Rico.