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Diagnosing Epilepsy To EffeCT Change

Epiminder America, Inc. · NCT07110337

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
210
US sites recruiting
22
Study start
December 23, 2025
Record last updated
October 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)

Conditions: Epilepsy; Epilepsy (Treatment Refractory)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • UAB Epilepsy Center

    Birmingham, AL 35233

    Site contact: Jennifer Pilkington · 205-934-8352 · jlpilkington@uabmc.edu

  • Mayo Clinic - Arizona

    Phoenix, AZ 85054

    Site contact: Neil Santos · 480-301-4252 · santos.neil@mayo.edu

  • University of California, Irvine Medical Center

    Irvine, CA 92612

    Site contact: Senada Martin · 866-839-3247 · clinicalresearch@hs.uci.edu

  • Stanford

    Palo Alto, CA 94304

    Site contact: Adele Viviani · (650) 285-9180 · aviviani@stanford.edu

  • UC San Diego Health

    San Diego, CA 92037

    Site contact: Alpha Clinic intake · 858-249-4020 · AlphaStemCellClinic@health.ucsd.edu

  • Yale School of Medicine

    New Haven, CT 06510

    Site contact: Danielle Carlson · 612-594-4080 · danielle.carlson@yale.edu

  • Mayo Clinic - Florida

    Jacksonville, FL 32224

    Site contact: Christina Cesta · 904-953-5701 · Cesta.Christina@mayo.edu

  • Nicklaus Children's Hospital

    Miami, FL 33155

    Site contact: Juliana Montoya, RN, BSN, BS · (786) 624 -3595 · Juliana.Montoya@nicklaushealth.org

  • USF Health

    Tampa, FL 33606

    Site contact: Marina Azevedo · 813-250-2323 · azevedom@usf.edu

  • IU Health Neuroscience Center

    Indianapolis, IN 46202

    Site contact: Caliel D Hines · 317-963-7010 · calhines@iu.edu

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Emory Peng · 617-726-3311 · epeng@mgh.harvard.edu

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Masumi Prasad · 617-975-8684 · mprasad2@bidmc.harvard.edu

  • Michigan Medicine

    Ann Arbor, MI 48109

    Site contact: Cate Cochren · 734-232-1199 · cathlewi@med.umich.edu

  • University of Minnesota

    Minneapolis, MN 55455

    Site contact: Adam Hansen · 763-807-1858 · hans5057@umn.edu

  • Mayo Clinic - Rochester

    Rochester, MN 55905

    Site contact: Sherry Klingerman · 507-284-0451 · klingerman.sherry@mayo.edu

  • Washington University

    St Louis, MO 63130

    Site contact: Victoria Taylor, MD · 314-362-7871 · v.taylor@wustl.edu

  • Billings Clinic

    Billings, MT 59101

    Site contact: Karla A. Mora Rodriquez, MD · 406-435-7480 · CancerResearch@billingsclinic.org

  • Atrium Health Neurosciences Institute - Charlotte

    Charlotte, NC 28204

    Site contact: Gina M'Buyamba · 704-355-9434 · Gina.MBuyamba@advocatehealth.org

  • Duke University

    Durham, NC 27710

    Site contact: Lisa Gauger · (919) 668-1538 · lisa.gauger@duke.edu

  • University Hospitals Cleveland Medical Center

    Clevland, OH 44106

    Site contact: Kevin Hricik · 216-286-5295 · Kevin.Hricik@uhhospitals.org

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: T. Mindy Ganguly, M.D. · 215-662-7227 · epilepsyresearch@pennmedicine.upenn.edu

  • University of Texas Health Science Center at Houston

    Houston, TX 77030

    Site contact: Saad Ahmad, MBBS · 713-500-7894 · epilepsy.research@uth.tmc.edu

Study contacts (from the official record)

  • Epiminder, Director of Clinical Trials · 800-717-3185 · clinical@epiminder.com
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Diagnosing Epilepsy To EffeCT Change (NCT07110337) | Bored Studies