Home › Epilepsy › NCT07110337
Diagnosing Epilepsy To EffeCT Change
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
Who can join
Ages 18 to 75 · All sexes
Full 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
About the study
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.
What is being tested
- Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system) (device)
Sponsor: Epiminder America, Inc. · Participants: 210 · Started: Dec 23, 2025
Contact the study team
- Epiminder, Director of Clinical Trials · Phone: 800-717-3185
Official record on ClinicalTrials.gov — NCT07110337
Locations in the U.S.
| Alabama | UAB Epilepsy Center, Birmingham |
| Arizona | Mayo Clinic - Arizona, Phoenix |
| California | University of California, Irvine Medical Center, Irvine Stanford, Palo Alto |
| Connecticut | Yale School of Medicine, New Haven |
| Florida | Mayo Clinic - Florida, Jacksonville Nicklaus Children's Hospital, Miami USF Health, Tampa |
| Indiana | IU Health Neuroscience Center, Indianapolis |
| Massachusetts | Beth Israel Deaconess Medical Center, Boston Massachusetts General Hospital, Boston |
| Michigan | Michigan Medicine, Ann Arbor |
| Minnesota | University of Minnesota, Minneapolis Mayo Clinic - Rochester, Rochester |
| Missouri | Washington University, St Louis |
| Montana | Billings Clinic, Billings |
| North Carolina | Atrium Health Neurosciences Institute - Charlotte, Charlotte Duke University, Durham |
| Ohio | University Hospitals Cleveland Medical Center, Clevland |
| Pennsylvania | University of Pennsylvania, Philadelphia |
| Texas | University of Texas Health Science Center at Houston, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.