Optimizing Therapy in Epilepsy Using Seizure Forecasts Via EEG and Wearables
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMayo Clinic
About this trial
The purpose of this study is to evaluate the safety and feasibility of using seizure forecasts based on subscalp EEG.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- UNEEG SubQ device
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Mayo Clinic
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov