Diagnosing Epilepsy To EffeCT Change
Purpose
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.
Conditions
- Epilepsy
- Epilepsy (Treatment Refractory)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Minder System Treatment Arm |
|
|
|
Placebo Comparator Minder System Control Arm |
|
|
|
No Intervention Standard of Care Arm |
|
Recruiting Locations
Irvine, California 92612
New Haven, Connecticut 06510
Jacksonville, Florida 32224
Miami, Florida 33155
Indianapolis, Indiana 46202
Boston, Massachusetts 02114
Boston, Massachusetts 02215
Ann Arbor, Michigan 48109
Minneapolis, Minnesota 55455
Rochester, Minnesota 55905
St Louis, Missouri 63130
Charlotte, North Carolina 28204
Durham, North Carolina 27710
Clevland, Ohio 44106
Philadelphia, Pennsylvania 19104
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Epiminder America, Inc.