Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

Recruiting now

Conditions studied: Epilepsy, Epilepsy (Treatment Refractory)

In brief

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.

Key facts

Study ID

NCT07110454

Run by

Epiminder America, Inc.

People needed

210

Starts

2026-06-01

Expected to finish

2029-01-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Stanford — Palo Alto, California, United States (enrolling)
• Stanford — Palo Alto, California, United States (enrolling)
• Yale School of Medicine — New Haven, Connecticut, United States (enrolling)
• Mayo Clinic - Florida — Jacksonville, Florida, United States (enrolling)
• Nicklaus Children's Hospital — Miami, Florida, United States (enrolling)
• USF Health — Tampa, Florida, United States (enrolling)
• Mayo Clinic - Arizona — Phoenix, Arizona, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Atrium Health Neurosciences Institute - Charlotte — Charlotte, North Carolina, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• IU Health Neuroscience Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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