Clinical trial Recruiting at 23 sites Interventional Ages 18 to 75

Minder sub‑scalp EEG to improve diagnosis and care for epilepsy

Official title: A Prospective Study to Evaluate the Use of the Minder Device to Aid in Developing a Treatment Plan After Inconclusive Prolonged EEG in Patients With Epilepsy

Run by Epiminder America, Inc. · NCT07110337 · Data updated 2026-11-12

This test will see if the Minder sub‑scalp EEG device gives more reliable, long‑term seizure data than usual care for people with drug‑resistant epilepsy whose seizures aren't well captured by standard EEG.

More Epilepsy trials

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment210 (estimated)
SponsorEpiminder America, Inc.
Industry-sponsored
Locations23 sites (Birmingham, Alabama and 22 other locations)
StatusRecruiting
StartedDecember 23, 2025
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedOctober 26, 2026
Trial IDNCT07110337 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people with focal or generalized drug‑resistant epilepsy who have had at least one seizure in the past three months and who had an inconclusive multi‑day EEG.

Probably not a fit

Patients who recently had epilepsy surgery, who have active implanted neurostimulators (DBS/RNS), who require MRI/ECT/lithotripsy, or who cannot undergo implantation are unlikely to benefit from this option.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares continuous sub‑scalp EEG monitoring with the Minder System to standard of care for people with drug‑resistant epilepsy whose seizures are not well captured by routine EEG. Participants either opt for implantation of the Minder device or continue with standard care; those who receive the implant are then randomized so their treating physician either has access to the continuously recorded EEG data or does not. The Minder System is FDA De Novo–classified and records continuous EEG from under the scalp to capture seizures that short‑term EEGs can miss. Outcomes focus on whether the device provides more reliable seizure data that can inform long‑term management.

Why it matters

Potential benefit: If successful, this could give doctors a much clearer, continuous view of seizure activity so they can make better treatment decisions and reduce diagnostic delays.

How similar studies have gone: Prior research on continuous sub‑scalp and long‑term EEG monitoring has shown promise for detecting seizures missed by routine EEG, but large randomized data on clinical outcomes remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of focal and/or generalized epilepsy.
* Drug-resistant
* At least an average of 1 seizure within the past 3 months
* Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring.

Exclusion Criteria:

* Epilepsy surgery within the past 6 months
* Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS)
* Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy
* Participant cannot have surgery to have the device implanted

Where it's running

  • UAB Epilepsy Center
    Birmingham, Alabama, United States
    Recruiting
  • Mayo Clinic - Arizona
    Phoenix, Arizona, United States
    Recruiting
  • University of California, Irvine Medical Center
    Irvine, California, United States
    Recruiting
  • Stanford
    Palo Alto, California, United States
    Recruiting
  • UC San Diego Health
    San Diego, California, United States
    Recruiting
  • Yale School of Medicine
    New Haven, Connecticut, United States
    Recruiting
Show 17 more locations
  • Mayo Clinic - Florida
    Jacksonville, Florida, United States
    Recruiting
  • Nicklaus Children's Hospital
    Miami, Florida, United States
    Recruiting
  • USF Health
    Tampa, Florida, United States
    Recruiting
  • IU Health Neuroscience Center
    Indianapolis, Indiana, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Michigan Medicine
    Ann Arbor, Michigan, United States
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting
  • Mayo Clinic - Rochester
    Rochester, Minnesota, United States
    Recruiting
  • Washington University
    St Louis, Missouri, United States
    Recruiting
  • Billings Clinic
    Billings, Montana, United States
    Recruiting
  • Atrium Health Neurosciences Institute - Charlotte
    Charlotte, North Carolina, United States
    Recruiting
  • Duke University
    Durham, North Carolina, United States
    Recruiting
  • University Hospitals Cleveland Medical Center
    Clevland, Ohio, United States
    Recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania, United States
    Recruiting
  • UT Southwestern Medical Center
    Dallas, Texas, United States
    Recruiting
  • University of Texas Health Science Center at Houston
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.