Predicting seizures with a wearable EEG headband
A Multicenter Prospective Non-Interventional Pilot Feasibility Trial for Seizure Prediction Using Wearable Electroencephalogram Among Patients With Confirmed Epilepsy
This project will test whether a comfortable wearable EEG headband can give people with epilepsy an early warning by recording brain activity at home for several weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Dux Healthcare Inc. Industry-sponsored |
| Locations | 2 sites (Haifa and 1 other locations) |
| Trial ID | NCT06978842 on ClinicalTrials.gov |
What this trial studies
This observational study asks people with epilepsy to wear a consumer-grade EEG headband daily for at least 12 weeks while a mobile app uploads their brain signals to secure cloud storage. Participants log seizures in the app and researchers combine these reports with clinical records to label events. A personalized algorithm developed from retrospective hospital EEG data will try to detect pre-ictal patterns and provide real-time predictions while controlling false alarm rates. No medications or treatments are changed—researchers are only collecting and analyzing EEG data to see if prediction is feasible with wearable devices.
Who should consider this trial
Good fit: Ideal candidates are people aged 12 or older with a confirmed epilepsy diagnosis who have had at least one seizure captured on prior EEG, experience roughly daily to two seizures in three months, and can use a compatible smartphone (or have caregiver support) to manage the headband and app.
Not a fit: People who cannot wear the headband because of scalp conditions or fit issues, those without a compatible smartphone or reliable Bluetooth/data access, pregnant individuals, or people with very infrequent seizures are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could give people with epilepsy timely warnings before seizures, improving safety and independence.
How similar studies have performed: Previous retrospective and hospital EEG studies have shown promising pre-ictal patterns, but prospective real-time seizure prediction using consumer-grade wearables remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 12 years and older. * Diagnosis of epilepsy confirmed by EEG, with at least one seizure captured during EEG monitoring by a trained expert. * Seizure frequency ranging from once per day to two over the last three months preceding inclusion. * 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. Exclusion Criteria: * 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.
Where this trial is running
Haifa and 1 other locations
- Rambam Medical Center — Haifa, Israel (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.