NCT07012148

Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables

FORESITE (FOREcasting Seizures to Initiate ThErapy): Optimizing Management of Drug-Resistant Epilepsy Using Seizure Forecasts Via Subscalp EEG and Wearables

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and feasibility of using seizure forecasts based on subscalp EEG.

Conditions

• Focal Epilepsy
• Generalized Seizure
• Drug Refractory Epilepsy

Interventions

Type	Name	Description
DEVICE	UNEEG 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.

Timeline

• Start date: 2026-01-20
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2025-06-10
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study