EpilepsyDETECTNCT07110337
Diagnosing Epilepsy To EffeCT Change
A study testing Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system) in people with Epilepsy and Epilepsy (Treatment Refractory), run by Epiminder America, Inc. at 22 sites in United States.
Trial summary
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. 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?
- Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 22 sitesUnited States
- Study dates
- 23 Dec 2025to Jun 2027
- Phase
- Interventional
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 22 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, 617-726-3311, 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
Clevland, 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
Shurti Agashe, MD
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Saad Ahmad, MBBS, 713-500-7894, epilepsy.research@uth.tmc.edu
Samden Lhatoo, MD
- Recruiting
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
Caliel D Hines, 317-963-7010, calhines@iu.edu
David A Purger, MD, PhD
- Recruiting
University of California, Irvine Medical Center
Irvine, California, 92612
Senada Martin, 866-839-3247, clinicalresearch@hs.uci.edu
Kurt Qing, MD, PhD
- Recruiting
Mayo Clinic - Florida
Jacksonville, Florida, 32224
Christina Cesta, 904-953-5701, Cesta.Christina@mayo.edu
Brin Freund, MD
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
Juliana Montoya, RN, BSN, BS, (786) 624 -3595, 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, 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, M.D., 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 Study to Evaluate the Use of the Minder Device to Aid in Developing a Treatment Plan After Inconclusive Prolonged EEG in Patients With Epilepsy
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.
- Conditions
- Epilepsy, Epilepsy (Treatment Refractory)
- Being tested
- Receipt of the Minder System (implantable sub-scalp 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.
Receipt of the Minder System (implantable sub-scalp 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 unit that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.
| Study group | Role | What they receive |
|---|---|---|
| Minder System Treatment Arm | Experimental | Not described Receives: Device: Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system) |
| Minder System Control Arm | Placebo comparator | Not described Receives: Device: Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system) |
| Standard of Care Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the proportion of participants receiving the Minder System with those receiving Standard of Care (SOC) as a means of obtaining an actionable event based on clinical data (i.e. Minder EEG data, non-Minder EEG data, SOC assessments, etc.).
Measured: 6 months
Secondary outcomes (6)
Compare the time to the first actionable event.
Measured: 6 months
Compare participant wellbeing between groups with the Beck Depression Inventory (BDI) for symptoms associated with depression.
Measured: 6 months
Compare participant wellbeing between groups with the Beck Anxiety Inventory (BAI) for symptoms associated with anxiety.
Measured: 6 months
Compare healthcare utilization between groups by the number of hospital visits.
Measured: 6 months
Compare healthcare utilization between groups by medication usage.
Measured: 6 months
Compare healthcare utilization between groups by the number of surgeries or procedures.
Measured: 6 months
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 completionJun 2027 (estimated)
- Study completionJun 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- 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
- NCT07110337
- Sponsor's protocol ID
- EM2401
- Acronym
- DETECT
- 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