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Diagnosing Epilepsy To EffeCT Change

RecruitingNAAges 18 Years - 75 YearsAllEpiminder America, Inc.
NCT07110337 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating ph

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📋 Eligibility rules (as published)
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
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What it tests

  • Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)
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Where

23 sites
UAB Epilepsy Center
Birmingham, United States
Mayo Clinic - Arizona
Phoenix, United States
University of California, Irvine Medical Center
Irvine, United States
Stanford
Palo Alto, United States
UC San Diego Health
San Diego, United States
Yale School of Medicine
New Haven, United States
Mayo Clinic - Florida
Jacksonville, United States
Nicklaus Children's Hospital
Miami, United States

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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