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

Study on Minder Device for Seizure Monitoring

J
Jason Schwalb

Primary Investigator

Enrolling By Invitation
18 years - 75 years
All
Phase N/A
8 participants needed
2 Locations

Brief description of 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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

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.

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:

  • 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

This study investigates the use of the Minder device in people with epilepsy. Epilepsy is a condition that affects the brain and causes seizures. The purpose of this study is to see if the Minder device can help in creating a treatment plan for those whose seizures are not easily captured by regular tests. The study compares the Minder System to the usual care to see which provides better seizure data.

Participants will either have the Minder device implanted or continue with their usual care. Some participants with the Minder device will have their doctors access the data, while others will not. This is done to see if having the data helps doctors make better treatment plans. Participants will not know which group they are in until the study ends. The Minder device is placed under the scalp and helps track seizures.

  • Who can participate: Adults with focal or generalized epilepsy who have drug-resistant seizures and have had at least one seizure in the past three months can join. They must have completed a multi-day EEG that was inconclusive. Participants should not have had epilepsy surgery in the last six months or need treatments not compatible with the Minder device.
  • Study details: Participants will have the Minder device implanted under the scalp or continue with their usual care. The Minder device collects data on seizures, which may or may not be shared with their doctor. This helps to see if the device improves treatment planning.
  • Study timelines: The study will last 6 months.
Updated on 09 Apr 2026. Study ID: SNEU-EPIMINDER-DETECT, 29116
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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