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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* In the investigator's judgment, able to comply with study procedures.
Exclusion Criteria:
* 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.
* Participation in another investigational study that, in the investigator's judgment, could interfere with TRACE procedures or outcomes.
Primary outcome measure(s)
Event-Level Seizure Detection by Subgaleal EEG Compared With SEEG — During concurrent sgEEG and standard-of-care SEEG monitoring, up to 14 days 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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