Minder System for Epilepsy Diagnosis

This study is for people aged 18 to 75 with drug-resistant epilepsy, especially if standard EEG (electroencephalography, a test that measures brain waves) hasn't clearly shown where your seizures start. The study aims to see if the Minder System, an implanted device under your scalp that continuously records brain activity, is better than standard care at providing useful information about your seizures. The Minder System is already approved by the FDA. You would either receive the Minder System implant or continue with your usual care. The main goal is to compare how well each approach helps doctors get actionable information about your epilepsy over 6 months.

Study design
This study is comparing two groups: one receiving the Minder System and one receiving standard care. It plans to enroll 210 participants.
What's involved
Participants will either have the Minder device implanted or continue with their standard care. The study will compare results over 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary comparison of the Minder System versus standard care is measured at 6 months.

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NCT07110337

Diagnosing Epilepsy To EffeCT Change

Recruiting
NAAges 18–75InterventionalDiagnostic
Epiminder America, Inc.
~210 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare the proportion of participants receiving the Minder System with those receiving Standard of Care (SOC) as a means of obtaining an actionable event based on clinical data (i.e. Minder EEG data, non-Minder EEG data, SOC assessments, etc.).
Measured over 6 months
Epilepsy
Epilepsy (Treatment Refractory)
19 sites across 13 states
Florida3
California2
Massachusetts2
Minnesota2
North Carolina2
Arizona1
Connecticut1
Indiana1
Epiminder, Director of Clinical Trials
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Compare the proportion of participants receiving the Minder System with those receiving Standard of Care (SOC) as a means of obtaining an actionable event based on clinical data (i.e. Minder EEG data, non-Minder EEG data, SOC assessments, etc.).6 months