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A less invasive brain monitor takes on Epilepsy's hardest seizures

NCT ID NCT07821697

Diagnosis Sponsor: Adraxe Corp. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether a minimally invasive electrode placed under the scalp, called subgaleal EEG, can detect seizures as well as the standard approach that places electrodes inside the brain. The study enrolls 15 adults with drug-resistant epilepsy who are already scheduled for inpatient stereoelectroencephalography (SEEG) monitoring. Both recordings run at the same time, and the team compares how well subgaleal EEG identifies seizures, measures signal quality, and locates where seizures start. The goal is to see whether a less invasive method could one day support epilepsy monitoring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Subgaleal EEG recording, a minimally invasive electrode placed under the scalp to record brain signals
What this could lead to
If subgaleal EEG can reliably detect and localize seizures, it could offer a less invasive way to monitor epilepsy than electrodes placed inside the brain.
What could go wrong
This is a small, early-stage recording study with only 15 participants, so it may not show that subgaleal EEG is accurate enough. It records signals during a hospital stay and does not test whether the approach improves treatment or outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy (treatment refractory)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Minnisota

    Minneapolis, Minnesota, 55414, United States

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