Diagnosing Epilepsy To EffeCT Change

Launched by EPIMINDER AMERICA, INC. · Aug 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Minder System, which helps doctors better understand and manage epilepsy, especially for people whose seizures are hard to detect with usual tests. The Minder System is a small device implanted just under the scalp that continuously records brain activity to catch seizures that standard tests might miss. The study will compare how well this device works compared to the usual care people receive now.

People eligible for this study are those diagnosed with epilepsy that doesn’t respond well to medication and who have had at least one seizure in the past three months. They also need to have had an EEG test (a common brain wave test) that didn’t give clear results. Participants will either have the Minder device implanted or continue with their current care. Those with the device will be randomly placed into two groups: one where their doctor can see the brain data collected by the device and one where the doctor cannot, but participants won’t know which group they’re in. Everyone will continue regular doctor visits for up to six months to help decide the best treatment plan. This study is not yet recruiting but welcomes adults of all genders who meet these criteria.

Gender

ALL

Eligibility 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