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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Epiminder America, Inc. Industry-sponsored |
| Locations | 23 sites (Birmingham, Alabama and 22 other locations) |
| Status | Recruiting |
| Started | December 23, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07110337 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
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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
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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
- Study coordinator: Epiminder, Director of Clinical Trials
- Email: clinical@epiminder.com
- Phone: 800-717-3185
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy
This study tests whether low intensity focused ultrasound can help reduce seizures in adults with drug‑resistant epilepsy.
-
Long-term follow-up of the Minder implanted EEG system for epilepsy care
This follow-up will see if long-term use of the implanted Minder sub‑scalp EEG system helps doctors manage care for people with epilepsy whose seizures are not well captured by standard EEGs.
-
RAP-219 long-acting injectable safety and PK study in healthy adults
This early study tests RAP-219-LAI in healthy adults to see how it behaves in the body and whether it is safe and tolerable.
-
Why People with Epilepsy Get More Infections
This study tests whether anti-seizure medicines affect immune function and infection risk in people with epilepsy.
-
Long-Term Epilepsy Outcomes in Children After Perinatal Stroke
This study looks at how epilepsy progresses in kids who had a stroke before 28 days old to see how their seizures and syndromes evolve over time.
-
Hypothalamus structure and heart autonomic changes in drug-resistant epilepsy
This study tests whether structural changes in the hypothalamus relate to cardiac autonomic dysfunction in adults with drug-resistant epilepsy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.