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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Minder System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Participants previously implanted with the Minder device
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Epiminder, Director of Clinical Trials | Contact | 800-717-3185 | clinical@epiminder.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Arizona | Recruiting | Phoenix | Arizona | 85054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40445205 | Result | 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. |
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|
| 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 |
| To evaluate the Minder System to aid in treatment following an actionable event by comparing healthcare utilization by medication usage. | 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. | 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. | 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. | 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. | 2 years |
| Stanford | Recruiting | Palo Alto | California | 94304 | United States |
|
| Yale School of Medicine | Recruiting | New Haven | Connecticut | 06510 | United States |
|
| Mayo Clinic - Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| USF Health | Recruiting | Tampa | Florida | 33606 | United States |
|
| IU Health Neuroscience Center | Enrolling by invitation | Indianapolis | Indiana | 46202 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Mayo Clinic - Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Washington University | Recruiting | St Louis | Missouri | 63130 | United States |
|
| Atrium Health Neurosciences Institute - Charlotte | Recruiting | Charlotte | North Carolina | 28204 | United States |
|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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