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Subgaleal EEG for Epilepsy

(TRCE Trial)

SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Adraxe Corp.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with drug-resistant epilepsy who are already scheduled to have inpatient SEEG monitoring as part of their standard care. Participants must be able to undergo EEG recording during their hospital stay.

Inclusion Criteria

In the investigator's judgment, able to comply with study procedures
Able and willing to provide written informed consent
I am 18 years old or older.
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Exclusion Criteria

Any medical, neurological, psychiatric, or social condition that would make participation unsafe or interfere with study procedures or data interpretation
I do not have any active infection or skin issues where the electrode will be placed.
I have a bleeding disorder or take blood thinners that can't be safely managed for the procedure.
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What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing a new way of recording brain signals called subgaleal EEG (sgEEG) at the same time as the usual SEEG monitoring, without adding any treatments or changes to patient care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adraxe Corp.

Lead Sponsor

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