Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07012148
Status
Recruiting
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Conditions

  • Drug Refractory Epilepsy
  • Focal Epilepsy
  • Generalized Seizure

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • UNEEG SubQ device — 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.

Study Details

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

Key Dates

Start date
Jan 20, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: subscalp EEG
    All study subjects will be implanted with the UNEEG SubQ device.

Primary Outcome Measure

Safety and Adverse Events [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Benjamin Henry Brinkmann (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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