FORESITE (FOREcasting Seizures to Initiate ThErapy): Optimizing Management of Drug-Resistant Epilepsy Using Seizure Forecasts Via Subscalp EEG and Wearables
Mayo Clinic
Summary
The purpose of this study is to evaluate the safety and feasibility of using seizure forecasts based on subscalp EEG.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects enrolled in this study must have epilepsy involving the temporal lobe and will have undergone video-EEG monitoring within the past 3 years, and will have met the following criteria: * Focal epilepsy, including complex partial, and secondarily generalized seizures, including: * disabling seizure (i.e. involving loss of awareness, motor control, speech, or other essential functions) counts at least 2 per month on average over the preceding 3 months, established by verbal history or caregiver report. * For 3 months prior to enrollment, subject's AED dosages hav…
Interventions
- DeviceUNEEG SubQ device
Subjects will be implanted with the UNEEG SubQ device in the neurosurgical operating suite under general anesthesia. Electrodes will be placed over the temporal lobe of the hemisphere established as the origin of seizures by previous EEG monitoring. Only one UNEEG device will be placed, and only the seizure onset hemisphere will be covered.
Location
- Mayo Clinic in RochesterRochester, Minnesota