EpilepsyDETECT LTFUNCT07110454
Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up
An observational study of Epilepsy and Epilepsy (Treatment Refractory), run by Epiminder America, Inc. at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy, Epilepsy (Treatment Refractory)
- What is being tested?
- Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system)
- Type of treatment
- Medical device
- How many people
- 210 participants
- Where
- 21 sitesUnited States
- Study dates
- 23 Dec 2025to Jan 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants previously implanted with the Minder device
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites, 21 recruiting
- Recruiting
Michigan Medicine
Ann Arbor, Michigan, 48109
Cate Cochren, 734-232-1199, cathlewi@med.umich.edu
William Stacey, MD, PhD
- Recruiting
Billings Clinic
Billings, Montana, 59101
Karla A. Mora Rodriquez, MD, 406-435-7480, CancerResearch@billingsclinic.org
Karla A Mora Rodriquez, MD
- Recruiting
UAB Epilepsy Center
Birmingham, Alabama, 35233
Jennifer Pilkington, 205-934-8352, jlpilkington@uabmc.edu
Jerzy Szaflarski, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Emory Peng, 617-975-8692, epeng@mgh.harvard.edu
Peter Hadar, MD, MS
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Masumi Prasad, 617-975-8684, mprasad2@bidmc.harvard.edu
Niravkumar Barot, MD, MPH
- Recruiting
Atrium Health Neurosciences Institute - Charlotte
Charlotte, North Carolina, 28204
Gina M'Buyamba, 704-355-9434, Gina.MBuyamba@advocatehealth.org
Rajdeep Singh, MD
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Kevin Hricik, 216-286-5295, Kevin.Hricik@uhhospitals.org
Nathaly Contreras Cisneros, 216-844-2383, Nathaly.ContrerasCisneros@UHhospitals.org
- Recruiting
Duke University
Durham, North Carolina, 27710
Lisa Gauger, 919-668-1538, lisa.gauger@duke.edu
Shruti Agashe, MD
- Enrolling by invitation
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
- Recruiting
Mayo Clinic - Florida
Jacksonville, Florida, 32224
Christina Cesta, 904-953-5701, Cesta.Christina@mayo.edu
William Tatum, D.O.
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
Juliana Montoya, RN, BSN, BS, Juliana.Montoya@nicklaushealth.org
Matt Lallas, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Adam Hansen, 763-807-1858, hans5057@umn.edu
Sandipan Pati, MD
- Recruiting
Yale School of Medicine
New Haven, Connecticut, 06510
Danielle Carlson, 612-594-4080, danielle.carlson@yale.edu
Aline Herlopian, M.D
- Recruiting
Stanford
Palo Alto, California, 94304
Adele Viviani, 650-285-9180, aviviani@stanford.edu
Jessica Falco-Walter, MD
- Recruiting
Stanford
Palo Alto, California, 94304
Adele Viviani, 650-285-9180, aviviani@stanford.edu
Zahra Sadat Hossieny, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
T. Mindy Ganguly, MD, 215-662-7227, epilepsyresearch@pennmedicine.upenn.edu
T. Mindy Ganguly, M.D
- Recruiting
Mayo Clinic - Arizona
Phoenix, Arizona, 85054
Neil Santos, 480-301-4252, santos.neil@mayo.edu
Corneila Drees, M.D
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Sherry Klingerman, 507-284-0451, klingerman.sherry@mayo.edu
Brian Lundstrom, M.D., Ph.D.
- Recruiting
UC San Diego Health
San Diego, California, 92037
Alpha Clinic intake, 858-249-4020, AlphaStemCellClinic@health.ucsd.edu
Krisma C Montalvo, 858-862-0293, k1montalvo@health.ucsd.edu
- Recruiting
Washington University
St Louis, Missouri, 63130
Victoria Taylor, MD, 314-362-7871, v.taylor@wustl.edu
Johanna Sonnenschein, 314-273-8861, j.sonnenschein@wustl.edu
- Recruiting
USF Health
Tampa, Florida, 33606
Marina Azevedo, 813-250-2323, azevedom@usf.edu
Ushtar Amin, MD
About this study
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.
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)
- Being tested
- Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system)
- Keywords
- Minder System, Sub-scalp EEG monitoring device
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Minder System Receives: Device: Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start23 Dec 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epiminder America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110454
- Sponsor's protocol ID
- EM2402
- Acronym
- DETECT LTFU
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Halliday AJ, Gillinder L, Lai A, Seneviratne U, Fontenot H, Cameron T, McLean K, Niemiec A, Raghupathi R, Ganguly TM, Ellis C, Conrad EC, Briggs R, Bulluss K, Kwan P, Perucca P, O'Brien TJ, McGonigal A, Gutman M, Papacostas J, Fong MWK, Lee A, Crompton DE, Laing J, Wijayath M, Morokoff AP, Murphy M, D'Souza WJ, Cook MJ. The UMPIRE study: A first-in-human multicenter trial of bilateral subscalp monitoring for epileptic seizure detection. Epilepsia. 2025 Sep;66(9):3426-3439. doi: 10.1111/epi.18458. Epub 2025 May 30.
PubMed 40445205