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New implant could track seizures for months

NCT ID NCT04526418

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a small device implanted under the scalp to record brain waves (EEG) continuously for up to 12 weeks in people with epilepsy. The goal was to see if it could detect seizures better than standard short-term hospital monitoring and patient diaries. The trial involved 64 adults with temporal lobe epilepsy and compared the device's recordings to video-EEG in the hospital and seizure logs at home.

What this could mean

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

Active substance
24/7 EEG™ SubQ system (implanted device)
What this could lead to
If successful, this device could provide a more accurate and convenient way to track seizures over long periods, potentially improving epilepsy management.
What could go wrong
The trial was terminated early, so results are limited. The device is still experimental, and its accuracy and safety compared to standard monitoring are not fully established.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

64 people

The number who actually took part.

Started

Apr 2021

Finished

Aug 2025

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 to 75 years

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 1. Subject is 18-75 years old. 2. Semiology of seizures compatible with temporal lobe involvement. 3. Paraclinical findings supporting temporal seizure involvement. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT). 4. Uncontrolled epileptic seizures. 5. Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant. 6. Subject is willing and able to provide written informed consent. 7. Subject is able to complete all study-required procedures, assessments and follow-up. EXCLUSION CRITERIA 1. Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease. 2. Subject receives frequent (more than 2 days per week) treatment with drugs of the following types: 1. antiplatelets 2. anticoagulants 3. chemotherapeutics 4. non-steroid anti-inflammatory drugs (NSAID) 3. Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement. 4. Subject is involved in therapies with other active implantable devices that deliver electrical energy above the clavicular area, such as implantable brain stimulation, external/transcranial brain stimulation, vagus nerve stimulator (VNS) and cochlear implant(s). 5. Subject is pregnant 6. Subject has contraindicated profession or hobby 7. Subject is scheduled to undergo contraindicated treatments/investigations 8. Infection at the implant site 9. Subject has contraindication to the use of anesthetic used for in/ex plantation. 10. Subject is unable to use/operate the device system 11. Subject has abnormal Laboratory findings as follows: * Serum creatinine ≥ 3 times upper reference value * Alanine aminotransferase (ALT), alkaline phosphatase or bilirubin ≥ 3 times upper reference value * Activated Partial Thromboplastin Time (APTT) \> 50 seconds * thrombocyte count \< 50 or \>1000 x 109/L * International Normalised Ratio (INR) ≥ 1.6 * Any other clinical or paraclinical finding that in the opinion of the Investigator would interfere with participation in the study or would confound interpretation of the study results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cleveland Clinic, Neurological Institute

    Cleveland, Ohio, 44195, United States

  • Hackensack Meridian Health

    Neptune City, New Jersey, 07753, United States

  • Hopital Erasme - Universite Libre de Bruxelles

    Brussels, 1070, Belgium

  • Krankenhaus Mara, Gesellschaft für Epilepsieforschung e.V.

    Bielefeld, 33617, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Northwell Health Department of Neurosurgery

    Great Neck, New York, 11021, United States

  • UT Health Houston

    Houston, Texas, 77030, United States

  • University of California

    Los Angeles, California, 90095, United States

  • University of Pennsylvenia

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida (USF) Neurology Department

    Tampa, Florida, 33606, United States

  • Universität Klinikum Freibrug

    Freiburg im Breisgau, 79106, Germany

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