Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables (NCT07012148) | Clinical Trial Compass
RecruitingNot Applicable
Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables
United States12 participantsStarted 2026-01-20
Plain-language summary
The purpose of this study is to evaluate the safety and feasibility of using seizure forecasts based on subscalp EEG.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
Subjects enrolled in this study must have epilepsy involving the temporal lobe and will have undergone video-EEG monitoring within the past 3 years, and will have met the following 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 reg…