Seizure Prediction Using Wearable EEG

NCT06978842 | Recruiting

• 1 other identifier: RMB 049-25
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Epilepsy

Keywords

Seizue; Prediction; Wearable; EEG

Outcome Measures

Primary Outcomes (3)

• Seizure prediction sensitivity

  Proportion of EEG-labeled seizures correctly predicted by the algorithm within the predefined pre-ictal window.

  At the end of the 12-week monitoring period

• Seizure prediction specificity

  Proportion of time without seizures correctly classified as non-seizure periods by the algorithm.

  At the end of the 12-week monitoring period

• Seizure prediction false alarm rate

  Number of false alarms issued by the algorithm 48 hour of EEG monitoring

  At the end of the 12-week monitoring period

Secondary Outcomes (8)

• System uptime for real-time seizure prediction

  Throughout the 12-week study period

• Time Between Algorithm-Predicted Warning and Seizure Onset

  Throughout the 12-week study period

• Variability in Prediction Latency Across Events

  Throughout the 12-week study period

• Wearable EEG device battery and data usage

  Throughout the 12-week study period

• Participant Adherence to Device Usage, Measured by Daily Wear Time

  Throughout the 12-week study period

Interventions

Wearable EEG headband for passive brain signal acquisition DEVICE

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.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll up to 150 individuals aged 12 years and older with a confirmed diagnosis of epilepsy, who experience between one seizure per day and two seizures over the past three months. Participants must be capable of using a wearable EEG device at home and have access to a compatible smartphone. Recruitment will occur at a tertiary hospital and affiliated community clinics in Israel to ensure diversity in epilepsy severity and demographics. The population includes both adults and adolescents, with safeguards for minors and cognitively impaired participants.

You may qualify if:

• Age: 12 years and older.
• Diagnosis of epilepsy confirmed by EEG, with at least one seizure captured during EEG monitoring by a trained expert.
• Sufficient cognitive and physical ability (of the participant or caregiver) to comply with the protocol, including device management and data reporting.
• Access to and familiarity with a smartphone capable of running the study application as tested during screening.
• Willingness to provide informed consent and adhere to study procedures.

You may not qualify if:

• Scalp conditions or physical characteristics preventing proper device fit.
• Any technical or logistical challenges that would prevent reliable EEG data collection or compliance with the study protocol.
• Pregnant or planning a pregnancy during the study.

Sponsors & Collaborators

• Dux Healthcare Inc.: lead
• rs-ness: collaborator

Study Sites (2)

Rambam Medical Center

Haifa, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 18, 2025
• Study Start: June 19, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

IL (2)