RECRUITING

Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables

Conditions

Focal Epilepsy Generalized Seizure Drug Refractory Epilepsy complex partial seizure UNEEG seizure forecasting Subscalp EEG

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-08

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07012148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Jeff Laivell

CONTACT

507-538-8095

laivell.jeffrey@mayo.edu

William Tauer

CONTACT

507-293-2591

tauer.willliam@mayo.edu

Principal Investigator

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

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2029-12

Study Record Updates

Study Start Date2025-08

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

complex partial seizure
UNEEG
seizure forecasting
Subscalp EEG

Additional Relevant MeSH Terms

Focal Epilepsy
Generalized Seizure
Drug Refractory Epilepsy