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First-of-its-kind study will use FDA-cleared wearable technology to better understand and predict seizures.
February 23, 2024
By: Michael Barbella
Managing Editor
Empatica has announced plans to launch a first-of-its-kind study aimed at developing a seizure forecasting algorithm for people living with epilepsy, based on real-world data collected using its technology. More than 3 million Americans suffer from epilepsy, according to Centers for Disease Control statistics. And roughly one-third of people with epilepsy have refractory epilepsy, which occurs when medications no longer control seizures.1 Epileptic seizures are disruptive health events that can have a significant negative impact on quality of life and increase risk of injury and death for people with epilepsy. This study is designed to identify individualized periods of seizure risk for patients with epilepsy, using biomarker viability and patterns in patient lifestyle data as inputs to a forecasting algorithm. “Seizure forecasting has long been among the most-requested features for people with epilepsy. We are excited to announce our plans to begin a large clinical study aimed at using wearable technology to enable reliable seizure forecasting,” Empatica Co-Founder/Chief Scientist Dr. Rosalind Picard said. “Patients with epilepsy understand the toll that uncertainty around seizures takes and we hope that this study will help give them better control over their life, reducing stress and perhaps also enabling early interventions that ultimately reduce or prevent seizures from happening.” This study builds on Empatica’s proven experience in monitoring neurological conditions like epilepsy. Empatica’s Embrace smartwatch is the first and only U.s. Food and Drug Administration (FDA)-cleared wearable technology for detecting possible convulsive seizures, and one of the first AI-enabled medical products cleared by the FDA. Empatica’s wearables have also been previously used to successfully collect data shown to forecast seizures in a peer-reviewed study by the Mayo Clinic, King’s College and University of Melbourne, funded by the Epilepsy Foundation through the Seizure Gauge initiative.2 Through the upcoming study, Empatica plans to use its expertise in AI and machine learning, as well as its access to the largest real-world dataset of convulsive seizures, for the development of the seizure forecasting algorithm. This study also furthers Empatica’s work in developing AI-powered predictive algorithms. In 2021, the company developed an AI-based predictive algorithm that was CE-marked for medical use in the EU, focused on providing a warning when early signs of respiratory infections, including Covid-19, are detected. Study recruitment is expected to begin shortly. Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. Empatica’s platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. Its flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and the NASA-funded TRISH. References 1 https://www.cdc.gov/epilepsy/data/index.html 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8578354/
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