Seizure Prediction Using Wearable EEG

This observational study aims to evaluate the feasibility of real-time seizure prediction using non-invasive, wearable EEG devices in patients with epilepsy. The study focuses on identifying pre-ictal EEG patterns-subtle changes in brain activity that occur prior to seizure onset-and validating a prediction algorithm based on these patterns.

Epileptic seizures often occur unpredictably, significantly affecting patients' quality of life and safety. Existing seizure detection systems operate only after seizure onset. In contrast, predicting seizures before they occur could enable timely interventions, increase patient autonomy, and reduce the risks associated with uncontrolled seizures.

The study involves home use of consumer-grade wearable EEG devices (e.g., BrainBit and Muse headbands), which transmit EEG data via Bluetooth to a mobile app developed by the sponsor. Participants are instructed to wear the device daily for at least 12 weeks. The mobile app provides feedback on signal quality and securely uploads the data to the cloud for analysis. Participants can record seizures through the app, and researchers will also collect medical records for additional clinical annotations when available.

The prediction algorithm being tested uses personalized calibration and advanced statistical control of false alarm rates to ensure clinical viability. The algorithm was initially developed and tested using retrospective hospital-grade EEG data and publicly available datasets. This trial extends that work into the real world, evaluating the algorithm's performance prospectively on wearable data.

Key aims include:

Evaluating the usability of wearable EEG devices for long-term home use in a diverse patient population.

Identifying consistent pre-ictal EEG features within and across patients.

Validating the performance of the seizure prediction algorithm in terms of sensitivity, specificity, and false alarm rate.

Exploring the consistency of pre-ictal patterns across multiple seizures for the same patient.

This feasibility trial is non-interventional and does not alter participants' treatment plans. All data are collected passively and analyzed after being de-identified. Ethics approvals were obtained. The study is expected to contribute critical evidence toward the development of a clinically useful, AI-powered seizure forecasting system for real-world use.

• System uptime for real-time seizure prediction [Срок оценки: Throughout the 12-week study period]
• Time Between Algorithm-Predicted Warning and Seizure Onset [Срок оценки: Throughout the 12-week study period]
• Variability in Prediction Latency Across Events [Срок оценки: Throughout the 12-week study period]
• Wearable EEG device battery and data usage [Срок оценки: Throughout the 12-week study period]
• Participant Adherence to Device Usage, Measured by Daily Wear Time [Срок оценки: Throughout the 12-week study period]
• Usability of the wearable EEG system [Срок оценки: Week 0, Week 6, and Week 12]
• Frequency of Device-Related Skin Reactions [Срок оценки: Throughout the 12-week study period]
• Severity of Device-Related Skin Reactions (Graded by CTCAE v5.0) [Срок оценки: Throughout the 12-week study period]