Tests the Minder implant for seizure monitoring in people with epilepsy
Tests an implanted scalp device that records brain activity to guide epilepsy treatment.
Plain-language title generated from the registry record
Registry title: Diagnosing Epilepsy To EffeCT Change
Key facts
- Where
- Ann Arbor, Billings, Birmingham, Boston, Charlotte, Clevland, Dallas, Durham, Houston, Indianapolis, Irvine, Jacksonville, Miami, Minneapolis, New Haven, Palo Alto, Philadelphia, Phoenix, Rochester, San Diego, St Louis, and Tampa, United StatesSee the 23 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07110337, who can take part
Where in United States
- Michigan MedicineAnn Arbor, United StatesTaking people
- Billings ClinicBillings, United StatesTaking people
- UAB Epilepsy CenterBirmingham, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Atrium Health Neurosciences Institute ? CharlotteCharlotte, United StatesTaking people
- University Hospitals Cleveland Medical CenterClevland, United StatesTaking people
- UT Southwestern Medical CenterDallas, United StatesTaking people
- Duke UniversityDurham, United StatesTaking people
- University of Texas Health Science Center at HoustonHouston, United StatesTaking people
- IU Health Neuroscience CenterIndianapolis, United StatesTaking people
- University of California, Irvine Medical CenterIrvine, United StatesTaking people
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- Nicklaus Children's HospitalMiami, United StatesTaking people
- University of MinnesotaMinneapolis, United StatesTaking people
- Yale School of MedicineNew Haven, United StatesTaking people
- StanfordPalo Alto, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Mayo Clinic - ArizonaPhoenix, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- UC San Diego HealthSan Diego, United StatesTaking people
- Washington UniversitySt Louis, United StatesTaking people
- USF HealthTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Epiminder America, Inc.
- Trial code
- NCT07110337
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
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
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 physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends.
All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.
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: 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; Epilepsy surgery within the past 6 months; Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS).