Recruiting

Minder SystemDiagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

Sponsor:

Epiminder America, Inc.

Code:

NCT07110454

Conditions

Epilepsy

Epilepsy (Treatment Refractory)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Epilepsy

Epilepsy (Treatment Refractory)

Study ID

NCT07110454

Start date

Jun, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Minder System

Interventions

Previous 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.

Primary outcome measure

To evaluate the Minder System to aid in treatment following an actionable event by comparing change using the Patient Global Impression scale (PGIC) from baseline to follow-up. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Epiminder, Director of Clinical Trials

800-717-3185 clinical@epiminder.com

Locations

Mayo Clinic - Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Neil Santos

480-301-4252 santos.neil@mayo.edu

Principal Investigator:

Corneila Drees, M.D

Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Adele Viviani

650-285-9180 aviviani@stanford.edu

Principal Investigator:

Jessica Falco-Walter, MD

Stanford

Recruiting

Palo Alto, California, United States, 94304

Contacts

Adele Viviani

650-285-9180 aviviani@stanford.edu

Principal Investigator:

Zahra Sadat Hossieny, MD

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Danielle Carlson

612-594-4080 danielle.carlson@yale.edu

Principal Investigator:

Aline Herlopian, M.D

Mayo Clinic - Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Christina Cesta

904-953-5701 Cesta.Christina@mayo.edu

Principal Investigator:

William Tatum, D.O.

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Juliana Montoya, RN, BSN, BS

Juliana.Montoya@nicklaushealth.org

Principal Investigator:

Matt Lallas, MD

USF Health

Recruiting

Tampa, Florida, United States, 33606

Contacts

Marina Azevedo

813-250-2323 azevedom@usf.edu

Principal Investigator:

Ushtar Amin, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Emory Peng

617-975-8692 epeng@mgh.harvard.edu

Principal Investigator:

Peter Hadar, MD, MS

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Masumi Prasad

617-975-8684 mprasad2@bidmc.harvard.edu

Principal Investigator:

Niravkumar Barot, MD, MPH

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Sherry Klingerman

507-284-0451 klingerman.sherry@mayo.edu

Principal Investigator:

Brian Lundstrom, M.D., Ph.D.

Washington University

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Victoria Taylor, MD

314-362-7871 v.taylor@wustl.edu

Johanna Sonnenschein

314-273-8861 j.sonnenschein@wustl.edu

Principal Investigator:

Robert Hogan, M.D

Atrium Health Neurosciences Institute - Charlotte

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Gina M'Buyamba

704-355-9434 Gina.MBuyamba@advocatehealth.org

Principal Investigator:

Rajdeep Singh, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Lisa Gauger

919-668-1538 lisa.gauger@duke.edu

Principal Investigator:

Shruti Agashe, MD

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kevin Hricik

216-286-5295 Kevin.Hricik@uhhospitals.org

Nathaly Contreras Cisneros

216-844-2383 Nathaly.ContrerasCisneros@UHhospitals.org

Principal Investigator:

Michael Staudt, M.D.

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

T. Mindy Ganguly, MD

215-662-7227 epilepsyresearch@pennmedicine.upenn.edu

Principal Investigator:

T. Mindy Ganguly, M.D

More Information

Sponsor

Epiminder America, Inc.

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

Minder System
Sub-scalp EEG monitoring device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Epiminder America, Inc. on 2026-07-15.