Empatica announces plans for landmark clinical study to develop an AI-based seizure forecast based on wearable real-world data

One of our biggest goals at Empatica has always been to provide people and families living with epilepsy with more freedom and peace of mind, and seizure alerts were only the beginning.

We are excited to share that we are soon about to start a project that hasn’t been done before, with the support of our community. Register your interest today to stay updated.

More than 3 million Americans suffer from epilepsy, according to numbers from the Centers for Disease Control. And around one third of people with epilepsy have refractory epilepsy which occurs when medications no longer control seizures. 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.

In a statement, our Chief Scientist and Co-Founder Dr. Rosalind Picard talked about the importance of this initiative for the epilepsy community:

“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. 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 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.

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, Empatica developed an AI-based predictive algorithm which 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.

Recruitment for the study will begin in early 2024. Individuals who are interested in being contacted for study participation when recruitment begins can visit empatica.com/seizure-forecasting to learn more.