A Multicenter Prospective Non-Interventional Pilot Feasibility Trial for Seizure Prediction Using Wearable Electroencephalogram Among Patients With Confirmed Epilepsy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Rambam Medical Center
RECRUITING
Haifa
Sheba Medical Center
NOT_YET_RECRUITING
Ramat Gan
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2026-03
Participants
Target number of participants: 150
Related Therapeutic Areas
Sponsors
Leads: Dux Healthcare Inc.
Collaborators: rs-ness

This content was sourced from clinicaltrials.gov

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