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Not Yet Recruiting NCT07821697

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

Conditions: Epilepsy (Treatment Refractory)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 15
Sponsor: Adraxe Corp.

Location: University of Minnisota Minneapolis Minnesota

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07821697). StuddyBuddy aggregates publicly available trial information.