TRACE is a record-only study evaluating subgaleal EEG (sgEEG) recorded concurrently with standard-of-care stereoelectroencephalography (SEEG) in adults with drug-resistant epilepsy undergoing inpatient epilepsy monitoring. The study will assess the ability of sgEEG to detect seizures and characterize seizure timing, signal quality and stability, and lateralization compared with SEEG.
Adults aged 18 years or older.
Diagnosis of drug-resistant epilepsy.
Scheduled to undergo clinically indicated inpatient standard-of-care stereoelectroencephalography (SEEG) monitoring.
Able and willing to provide written informed consent.
Any medical, neurological, psychiatric, or social condition that, in the investigator's judgment, would make participation unsafe or interfere with study procedures or data interpretation.
Active infection, skin condition, or other finding at the planned subgaleal electrode placement site that could increase procedural risk.
Known bleeding disorder, clinically significant coagulopathy, or use of anticoagulant/antiplatelet therapy that cannot be managed per institutional requirements for the planned procedure.
Pregnancy or breastfeeding.
Single group
EEG Record only
DeviceSubgaleal EEG recording
Event-Level Seizure Detection by Subgaleal EEG Compared With SEEG
The proportion of clinically adjudicated SEEG seizures for which a corresponding event is identified on simultaneously recorded subgaleal EEG (sgEEG). SEEG serves as the reference standard.
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