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Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables

NCT07012148 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Benjamin Brinkmann, PhD · Mayo Clinic

  • Gregory A Worrell, MD, PhD · Mayo Clinic

  • Jamie J Van Gompel, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07012148 on ClinicalTrials.gov