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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
UNEEG SubQ device
DeviceSubjects will be implanted with the UNEEG SubQ device in the neurosurgical operating suite under general anesthesia. Electrodes will be placed over the temporal lobe of the hemisphere established as the origin of seizures by previous EEG monitoring. Only one UNEEG device will be placed, and only the seizure onset hemisphere will be covered.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: subscalp EEGExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Adverse Events
Number of device-related adverse events during the study period
Time frame
12 months2
Surgical and Device related adverse events
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.
Time frame
12 monthsSecondary outcomes
1
Quality of Life Inventory
The Quality of Life Inventory in Epilepsy (QOLIE-31) contains seven multi-item scales across the domains of emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life. Scoring of the QOLIE-31 requires the conversion of raw data to a scale of 0 to 100 for each sub-scale, with higher scores reflecting higher quality of life Timeframe: Baseline, 6 months, 12 months
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov