Epilepsy, Epilepsy (Treatment Refractory)
Conditions
Keywords
Minder System, Sub-scalp EEG monitoring device
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.
Interventions
DEVICEPrevious 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.
Sponsors
Epiminder America, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participant met all inclusion criteria, was enrolled in the DETECT study, and received the Minder device * 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 * Participant must continue to meet relevant DETECT study inclusion criteria
Exclusion criteria
* Participant meets any relevant DETECT study
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
CONTACTEpiminder, Director of Clinical Trials
Outcome results
None listed