Actively Recruiting
Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables
Led by Mayo Clinic · Updated on 2026-03-19
12
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and feasibility of using seizure forecasts based on subscalp EEG.
CONDITIONS
Official Title
Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Epilepsy involving the temporal lobe confirmed by video-EEG monitoring within the past 3 years
- Focal epilepsy with at least two disabling seizures per month on average over the past 3 months
- Stable antiepileptic drug doses (less than 25% change) for 3 months prior to enrollment
- Medically and neurologically stable except for epilepsy
- Ability and willingness to provide informed consent
- Ability to interpret and respond to device advisory indicators
- Seizures are distinct, stereotypical events reliably counted by the subject or caregiver
- Seizure EEG patterns can be recorded using subscalp EEG over the frontotemporal head region
- Ability to maintain a seizure diary alone or with assistance
- Ability to complete regular office visits and phone appointments
- Seizure focus consistently involves the temporal lobe based on clinical and EEG findings
- Ability to speak and read English
- No anticipated need for MRI evaluation within 2 years
- EEG documentation of ictal events consistent with predominant seizure type
- Anatomy suitable for implantation of the UNEEG SubQ device
- Female participants have a negative pregnancy test, do not plan pregnancy, and use effective contraception during the study
You will not qualify if you...
- Unstable antiepileptic drug doses (greater than 25% change) or more than 30 disabling seizures per month or more than 10 seizure days per month
- Need for MRI during the study period
- History of substance abuse within the last 2 years
- Participation in another drug or device trial within the last 30 days
- Hospitalization for psychiatric condition or history of psychosis within last 2 years (excluding post-ictal psychosis)
- Implanted medical devices that interfere with UNEEG device (except stable vagus nerve stimulators)
- History of unprovoked status epilepticus
- Prior therapeutic epilepsy surgery interfering with electrode placement
- Use of anticoagulants that cannot be stopped for surgery
- Significant platelet dysfunction unless approved by specialists
- Other medical or psychosocial factors contraindicating cranial surgery
- Pregnancy or plans to become pregnant during the study
- Diagnosis of psychogenic nonepileptic seizures (PNES)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
J
Jeff Laivell
CONTACT
W
William Tauer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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