Translational Recording and Characterization of Epilepsy Signals Using Subgaleal EEG During Standard-of-care SEEG Monitoring

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07821697

Acronym

TRCE

Enrollment

Registered

2026-09-16

Start date

2026-10-15

Completion date

2027-12-31

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy (Treatment Refractory)

Brief summary

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.

Interventions

DEVICEEEG Record only

Subgaleal EEG recording

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTStudy Coordinator

epilepsy@umn.edu763-807-1858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026