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.

Study on Investigational Device for Long-Term Epilepsy Management

Primary Investigator
J
Jason Schwalb

Primary Investigator

Enrolling By Invitation
18 years - 75 years
All
Phase N/A
10 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants that have completed the DETECT study and received the Minder System previously will be invited to join this long-term follow-up observational study.

Detailed description of 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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Epilepsy
  • Age: 18 years - 75 years
  • Gender: All

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)

This study investigates the use of the Minder device in people with epilepsy. Epilepsy is a condition where the brain has unexpected bursts of electrical activity, which can cause seizures. The purpose of this study is to see how the Minder device helps doctors make treatment decisions after important changes in a patient's condition are detected.

Participants will be observed over time to understand their overall wellbeing and how they use healthcare services while using the Minder device. They will visit their doctor and have check-ups every six months for two years after getting the Minder device.

  • Who can participate: Participants who completed the DETECT study and received the device are eligible. They must still have the device implanted.
  • Study details: Participants will continue to see their doctor and have regular check-ups every six months. They will share their experiences using the device to understand its impact on long-term epilepsy care.
  • Study timelines and visits: The study will last 2 years. The study requires 4 visits.
Updated on 18 Aug 2026. Study ID: 29283
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only