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

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

Not applicable Interventional Epiminder America, Inc. · NCT07110337

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.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment210 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEpiminder America, Inc. Industry-sponsored
Locations15 sites (Phoenix, Arizona and 14 other locations)
Trial IDNCT07110337 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

Phoenix, Arizona and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions EpilepsyMinder SystemSub-scalp EEG monitoring device
Last reviewed 2026-06-13 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.