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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Epiminder, Director of Clinical Trials contact

800-717-3185

clinical@epiminder.com

21 sites in 1 country

United States21 sites, 21 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

    Recruiting

  • IU Health Neuroscience Center

    Indianapolis, Indiana, 46202

    Enrolling by invitation

  • 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

    Recruiting

Other trials in United States

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.

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 groups in NCT07110454
Study groupRoleWhat they receive
ObservationalMinder 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.

  1. 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.

  1. First posted7 Aug 2025
  2. Study start23 Dec 2025
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy and Epilepsy (Treatment Refractory), run by Epiminder America, Inc. at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Epiminder, Director of Clinical Trials (800-717-3185, clinical@epiminder.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07110454, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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