Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up
NCT ID: NCT07110454
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
210 participants
OBSERVATIONAL
2026-01-31
2029-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational
Minder System
Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system)
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.
Interventions
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Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system)
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.
Eligibility Criteria
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Inclusion Criteria
* Participant continues to have the Minder device implanted
18 Years
75 Years
ALL
No
Sponsors
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Epiminder America, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic - Arizona
Phoenix, Arizona, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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EM2402
Identifier Type: -
Identifier Source: org_study_id
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