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

September 10, 2026 updated by: Adraxe Corp.
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnisota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Record only
Device: EEG Record only
Subgaleal EEG recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During concurrent sgEEG and standard-of-care SEEG monitoring, up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adraxe Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX-CP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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