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 diagnosing and long-term management of 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 will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends. All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.
Interventions
DEVICEReceipt of the Minder System (implantable sub-scalp 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 unit that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.
Sponsors
Epiminder America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of focal and/or generalized epilepsy. * Drug-resistant * At least an average of 1 seizure within the past 3 months * Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring.
Exclusion criteria
* Epilepsy surgery within the past 6 months * Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS) * Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy * Participant cannot have surgery to have the device implanted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the proportion of participants receiving the Minder System with those receiving Standard of Care (SOC) as a means of obtaining an actionable event based on clinical data (i.e. Minder EEG data, non-Minder EEG data, SOC assessments, etc.). | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Compare the time to the first actionable event. | 6 months |
| Compare participant wellbeing between groups with the Beck Depression Inventory (BDI) for symptoms associated with depression. | 6 months |
| Compare participant wellbeing between groups with the Beck Anxiety Inventory (BAI) for symptoms associated with anxiety. | 6 months |
| Compare healthcare utilization between groups by the number of hospital visits. | 6 months |
| Compare healthcare utilization between groups by medication usage. | 6 months |
| Compare healthcare utilization between groups by the number of surgeries or procedures. | 6 months |
Countries
United States
Contacts
CONTACTEpiminder, Director of Clinical Trials
Outcome results
None listed