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Seizure Prediction Using Wearable EEG
Sponsor: Dux Healthcare Inc.
Summary
This study is a non-interventional clinical trial analyzing EEG recordings from people with epilepsy. Participants wear a comfortable EEG headband at home for several weeks. The goal is to study changes in brain activity that occur before seizures (called "pre-ictal patterns") and to test whether a software algorithm can predict seizures in real-time based on these patterns. No treatments or medications are being tested. The study will help evaluate whether seizure prediction is possible using wearable EEG devices and can support the development of future tools that give patients early warnings before seizures occur.
Official title: A Multicenter Prospective Non-Interventional Pilot Feasibility Trial for Seizure Prediction Using Wearable Electroencephalogram Among Patients With Confirmed Epilepsy
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2025-06-19
Completion Date
2026-03
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
Wearable EEG headband for passive brain signal acquisition
This intervention involves the use of non-invasive, consumer-grade wearable EEG headbands to passively record brain activity from individuals with epilepsy in their natural home environments. The devices include BrainBit Headband, BrainBit Mindo, BrainBit Headphones, Muse 2, and Muse S. These devices transmit EEG signals via Bluetooth to a mobile application developed by the sponsor. The app provides real-time feedback on signal quality and securely uploads data to the cloud for offline analysis. The wearable devices are used solely for passive data acquisition and are not being evaluated for safety or therapeutic effectiveness in this study. No changes are made to clinical care or treatment.
Locations (2)
Rambam Medical Center
Haifa, Israel
Sheba Medical Center
Ramat Gan, Israel