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NCT Number: NCT07821697

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnisota

Minneapolis, Minnesota, 55414, United States

Location contact

Lindsey Study Coordinator

CONTACT

[email protected]

8582498702

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EEG Record only

Device

Subgaleal EEG recording

Primary outcomes

  1. Event-Level Seizure Detection by Subgaleal EEG Compared With SEEG

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

763-807-1858

Sponsors and collaborators

Lead sponsor

Adraxe Corp.

Industry

Registry information

Acronym: TRCE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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