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Optimizing Epilepsy Therapy with Seizure Forecasts

This study is looking at a new way to predict seizures in people with focal epilepsy, including complex partial and secondarily generalized seizures. It's testing the safety and practicality of using a small device called UNEEG SubQ, which is implanted under the skin. This device measures brain activity (EEG) to forecast seizures. You might be able to join if you are between 18 and 75 years old and have temporal lobe epilepsy that has been confirmed by previous EEG monitoring. The main goal is to see how safe the UNEEG SubQ device is and to track any side effects related to the surgery or the device over 12 months. This study plans to enroll 12 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 12 participants. It is not specified if it is randomized or blinded.
What's involved
You would have the UNEEG SubQ device implanted in your brain during surgery under general anesthesia. Electrodes would be placed over the temporal lobe.
Compensation
Not stated in the trial record.
Follow-up
Your safety and any adverse events will be monitored for 12 months after the device implantation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07012148

Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables

Recruiting
NAAges 18–75InterventionalDevice feasibility
Mayo Clinic
~12 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:UNEEG SubQ device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events
Measured over 12 months
+1 more outcome measured

Conditions

Focal Epilepsy
Generalized Seizure
Drug Refractory Epilepsy

Explore related trials

Generalized SeizurePartial Epilepsy

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Benjamin Brinkmann, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Gregory A Worrell, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Jamie J Van Gompel, MD · STUDY_DIRECTOR · Mayo Clinic

Who to contact

Jeff Laivell
[email protected]
507-538-8095
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 have been stable (less than a 25% change in dosage) and subject has had at least two seizures per month, on average, with a seizure-free interval not to exceed 60 days. Seizures must be separated by a minimum of four hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.
With the exception of epilepsy, subject must be medically and neurologically stable.
Age 18 to 75.
Ability and willingness to provide informed consent and participate in the study protocol. Subject is able to interpret and to respond, in accordance with the study protocol, to the advisory indicators provided by the device.
Subject has seizures that are distinct, stereotypical events that can be reliably counted by the subject or caregiver, and have a distinct EEG pattern that can be recorded using subscalp EEG over the frontotemporal head region, established by video-EEG monitoring.
Subject can reasonably be expected to maintain a seizure diary alone or with the assistance of a competent individual.
Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.
Subject's seizure focus, based upon clinical semiology, scalp EEG, intracranial electroencephalographic (iEEG) findings, and/or neuroimaging, demonstrate consistent involvement of the temporal lobe with their EEG seizure pattern.
Subject speaks and reads English.
Subject has no reason to anticipate requiring a magnetic resonance imaging (MRI) evaluation within the next two years.
Subject has EEG documentation of ictal events consistent with his or her predominant current seizure type.
Subject's anatomy will permit implantation of the UNEEG SubQ device in the opinion of the study's neurosurgeon.
Female subjects have a negative pregnancy test, have no plans to become pregnant, and use effective contraception during the study.

Exclusion

For 3 months prior to enrollment, subject's AED dosages have not been stable (greater than 25% change in dosage), or subject has had more than 30 disabling seizures per month, on average, or more than 10 seizure days per month, on average.
Subject needs to have magnetic resonance imaging during the study period.
Subject has a substance abuse history (alcohol, prescription, or illicit medications) within the preceding two years.
Subject participated in another drug or device trial within the preceding 30 days.
Subject has been hospitalized for a psychiatric condition within the preceding two years or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis).
Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, brain stimulator, or other medical device that would interfere with the UNEEG device. This includes, but is not limited to, direct brain neurostimulators, spinal cord stimulators, and cochlear implants. Vagus nerve stimulators are not expected to interfere with the subscalp EEG device and will be permitted, as long as stimulation parameters can be reasonably expected to remain stable (25% or less change in amplitude) throughout the study.
Subject has experienced unprovoked status epilepticus.
Subject has had therapeutic surgery to treat epilepsy that may interfere with electrode placement in the judgement of the neurosurgeon.
Subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or Investigator.
Subject has significant platelet dysfunction from medical conditions or medications (including, particularly, aspirin or sodium valproate). If platelet dysfunction is suspected, subject can be enrolled only if a hematologist, the Investigator, and the neurosurgeon judge it to be advisable. Blood tests to evaluate platelet and bleeding disorder issues will be obtained prior to enrollment.
Subject is otherwise ineligible for cranial surgery, or the Investigators identify other medical or psychosocial factors that would counter indicate participation in the study.
Subject is pregnant or intends to become pregnant during the study period.
Subject has a known diagnosis of psychogenic nonepileptic seizures (PNES)
Female subject is pregnant or plans to become pregnant.

What this trial measures

  • Safety and Adverse Events12 months

    Number of device-related adverse events during the study period

  • Surgical and Device related adverse events12 months

    Following surgery adverse events related to surgery and the device will be assessed, including: pain/soreness at the surgical site up to 1 week after surgery, pain/soreness at the surgical site after more than 1 week after surgery, headache (nonsurgical), skin irritation at transceiver position, excess bleeding, and infection; additionally, skin erosion will be assessed, and lead migration and fracture will be assessed by x-ray, if there is any concern for this, at the time of study completion prior to explantation.