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

NCT07821697 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ADX-CP-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy (Treatment Refractory)

Outcome Measures

Primary Outcomes (1)

• Event-Level Seizure Detection by Subgaleal EEG Compared With SEEG

  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

Study Arms (1)

Single arm

EXPERIMENTAL

Record only

Device: EEG Record only

Interventions

EEG Record only DEVICE

Subgaleal EEG recording

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adraxe Corp.: lead

Study Sites (1)

University of Minnisota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Study Coordinator

CONTACT

763-807-1858; epilepsy@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)