Diagnosing Epilepsy To EffeCT Change
Recruiting · NCT07110337 · Interventional (participants receive a specific treatment) · Lead sponsor: Epiminder America, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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. 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.
Who can take part
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
Where it is running
21 locations listed across 15 US states.
- UAB Epilepsy Center - Birmingham, Alabama, United States
- Mayo Clinic - Arizona - Phoenix, Arizona, United States
- University of California, Irvine Medical Center - Irvine, California, United States
- Stanford - Palo Alto, California, United States
- Yale School of Medicine - New Haven, Connecticut, United States
- Mayo Clinic - Florida - Jacksonville, Florida, United States
- Nicklaus Children's Hospital - Miami, Florida, United States
- USF Health - Tampa, Florida, United States
- IU Health Neuroscience Center - Indianapolis, Indiana, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Michigan Medicine - Ann Arbor, Michigan, United States
- University of Minnesota - Minneapolis, Minnesota, United States
- Mayo Clinic - Rochester - Rochester, Minnesota, United States
- Washington University - St Louis, Missouri, United States
- Billings Clinic - Billings, Montana, United States
- Atrium Health Neurosciences Institute - Charlotte - Charlotte, North Carolina, United States
- Duke University - Durham, North Carolina, United States
- University Hospitals Cleveland Medical Center - Clevland, Ohio, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- University of Texas Health Science Center at Houston - Houston, Texas, United States