Diagnosing Epilepsy To EffeCT Change
DETECT
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
1 other identifier
interventional
210
1 country
18
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2025
CompletedFirst Posted
Study publicly available on registry
August 7, 2025
CompletedStudy Start
First participant enrolled
December 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
June 4, 2026
May 1, 2026
1.4 years
July 24, 2025
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.).
6 months
Secondary Outcomes (6)
Compare the time to the first actionable event.
6 months
Compare participant wellbeing between groups with the Beck Depression Inventory (BDI) for symptoms associated with depression.
6 months
Compare participant wellbeing between groups with the Beck Anxiety Inventory (BAI) for symptoms associated with anxiety.
6 months
Compare healthcare utilization between groups by the number of hospital visits.
6 months
Compare healthcare utilization between groups by medication usage.
6 months
- +1 more secondary outcomes
Study Arms (3)
Minder System Treatment Arm
EXPERIMENTALMinder System Control Arm
PLACEBO COMPARATORStandard of Care Arm
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
University of California, Irvine Medical Center
Irvine, California, 92612, United States
Stanford
Palo Alto, California, 94304, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
USF Health
Tampa, Florida, 33606, United States
IU Health Neuroscience Center
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63130, United States
Atrium Health Neurosciences Institute - Charlotte
Charlotte, North Carolina, 28204, United States
Duke University
Durham, North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Clevland, Ohio, 44106, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 40445205RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2025
First Posted
August 7, 2025
Study Start
December 23, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share