RecruitingNCT07110454

Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

A Prospective Long-Term Follow-Up Study to Evaluate the Use of the Minder Device to Aid in Treatment After Actionable Event Identification in Patients Diagnosed With Epilepsy.


Sponsor

Epiminder America, Inc.

Enrollment

210 participants

Start Date

Jun 1, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

  • 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

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Interventions

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

The Minder System consists of an implanted device containing an electrode lead and telemetry unit. The electrode lead contains four electrodes that are placed under the patient's scalp to record electrical activity (EEGs) from both sides of the brain. The electrode lead is connected to the telemetry until that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.


Locations(9)

Mayo Clinic - Arizona

Phoenix, Arizona, United States

Stanford

Palo Alto, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Mayo Clinic - Florida

Jacksonville, Florida, United States

IU Health Neuroscience Center

Indianapolis, Indiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT07110454


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