Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up
DETECT LTFU
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.
1 other identifier
observational
210
1 country
12
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
May 18, 2026
May 1, 2026
2.6 years
July 24, 2025
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
2 years
Other Outcomes (8)
To evaluate the Minder System to aid in treatment following an actionable event by comparing change using Clinician Global Impression scale (CGIC) from baseline to follow-up.
2 years
To evaluate the Minder System to aid in treatment following an actionable event by comparing quality of life using the EQ-5D from baseline to follow-up.
2 years
To evaluate the Minder System to aid in treatment following an actionable event by comparing healthcare utilization by number of surgeries or procedures.
2 years
- +5 more other outcomes
Study Arms (1)
Observational
Minder System
Interventions
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
Participants previously implanted with the Minder device
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, 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
USF Health
Tampa, Florida, 33606, United States
IU Health Neuroscience Center
Indianapolis, Indiana, 46202, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, 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
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, 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
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2025
First Posted
August 7, 2025
Study Start
June 1, 2026
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share