Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Jerry J Shih, MD (ucsd)
Headshot of Jerry J Shih
Jerry J Shih

Description

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.

Official Title

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.

Keywords

Epilepsy, Epilepsy (Treatment Refractory), Minder System, Sub-scalp EEG monitoring device, Electroencephalography, Drug Delivery Systems, Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system)

Eligibility

You can join if…

Open to people ages 18-75

  • 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 CAN'T join 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)

Locations

  • UC San Diego Health accepting new patients
    San Diego California 92037 United States
  • Stanford accepting new patients
    Palo Alto California 94304 United States
  • Stanford accepting new patients
    Palo Alto California 94304 United States

Lead Scientist at University of California Health

  • Jerry J Shih, MD (ucsd)
    Professor Of Clinical, Neurosciences, Vc-health Sciences-schools

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Epiminder America, Inc.
ID
NCT07110454
Study Type
Observational
Participants
Expecting 210 study participants
Last Updated