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NCT07110454Recruiting

Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

Epiminder America, Inc.

Start Date

6/1/2026

Completion Date

1/1/2029

Summary

The purpose of this research is to address the challenges of correctly monitoring, managing, and diagnosing 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 is being done to understand how the Minder System helps physicians make decisions about participant's epilepsy treatment after an actionable event. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants that have completed the DETECT study and received the Minder System previously will consent to join this long-term follow-up observational study. The study will collect information about general wellbeing, use of healthcare services, and experience using the Minder data over time to support long-term epilepsy care. All participants will continue to be followed by their treating physician and undergo assessments and visits every six (6) months until two (2) years after receiving the Minder device.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: * Participant met all inclusion criteria, was enrolled in the DETECT study, and received the Minder device * Participant completed the DETECT study by receiving an actionable event or by completing the 6-month follow-up visit * Participant continues to have the Minder device implanted * Participant must continue to meet relevant DETECT study inclusion criteria Exclusion Criteria: * Participant meets any relevant DETECT study exclusion criteria including needing treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI)

Interventions

DEVICE

Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system)

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Conditions

EpilepsyEpilepsy (Treatment Refractory)

Locations

Mayo Clinic - Arizona

Phoenix, Arizona 85054

United States

Stanford

Palo Alto, California 94304

United States

Stanford

Palo Alto, California 94304

United States

Yale School of Medicine

New Haven, Connecticut 06510

United States

Mayo Clinic - Florida

Jacksonville, Florida 32224

United States

Nicklaus Children's Hospital

Miami, Florida 33155

United States

USF Health

Tampa, Florida 33606

United States

IU Health Neuroscience Center

Indianapolis, Indiana 46202

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Mayo Clinic - Rochester

Rochester, Minnesota 55905

United States

Washington University

St Louis, Missouri 63130

United States

Atrium Health Neurosciences Institute - Charlotte

Charlotte, North Carolina 28204

United States

Duke University

Durham, North Carolina 27710

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States