An observational study in Epilepsy and Epilepsy (Treatment Refractory), sponsored by Epiminder America, Inc.. Recruiting at 21 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Epiminder America, Inc. · Observational
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 210 is above the median of 112 across 540 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Epiminder America, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants previously implanted with the Minder device
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Minder System
Device: 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.
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.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
To evaluate the Minder System to aid in treatment following an actionable event by comparing healthcare utilization by medication usage.
Time frame: 2 years
To evaluate the Minder System to aid in treatment following an actionable event by comparing healthcare utilization by the number of hospital visits.
Time frame: 2 years
To evaluate the Minder System to aid in treatment following an actionable event by comparing participant wellbeing using the Beck Anxiety Inventory (BAI) for symptoms associated with anxiety from baseline to follow-up.
Time frame: 2 years
To evaluate the Minder System to aid in treatment following an actionable event by comparing participant wellbeing using the Beck Depression Inventory (BDI) for symptoms associated with depression from baseline to follow-up.
Time frame: 2 years
To evaluate the Minder System to aid in treatment following an actionable event by comparing quality of life using the Quality of life in epilepsy-31 (QOLIE-31) from baseline to follow-up.
Time frame: 2 years
Plan to share: No
Started Dec 2025 (actual). Primary completion is estimated for Jan 2029, 37 months after the start.
Of 37 industry-sponsored observational studies under Epilepsy, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 37 months is close to that.
Counting every sponsor, half of 230 studies reached it within 59 months; a quarter within 24 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Epiminder America, Inc.