NeuroPace
The NeuroPace RNS System is FDA-approved for adults with drug-resistant focal epilepsy but is not yet approved for adolescents. This study uses real-world data to evaluate the RNS System's safety and effectiveness in adolescents aged 12 through 17 who have already received the device in routine clinical practice. Data will come from patient-authorized electronic health records and patient-reported outcomes collected through a central study site, not a traditional trial infrastructure. Up to 100 evaluable patients across the United States sites will be enrolled, with results intended to support expansion of the RNS System's approved indication to include this adolescent population.
AURORA is a retrospective, observational, real-world evidence study run through OM1's Central Site model rather than a prospective trial infrastructure. NeuroPace identifies potentially eligible patients from its existing commercial implant records, stratified by age band (12-14 and 15-17 years) to ensure balanced representation, and nurse navigators conduct an initial prescreen before referring interested patients to OM1 for full informed consent, assent, and HIPAA authorization. EHR data are retrieved from each patient's own treating institutions into the OM1 Origin data warehouse, supplemen…
Inclusion Criteria: Aged 12-17 years at the time of first RNS neurostimulator implant Focal onset epilepsy diagnosis Implanted with the Model RNS-320 device No therapeutic surgeries performed concurrently with the RNS implant Single RNS device only at initial implant Implanted on or before December 31, 2024 Exclusion Criteria: Diagnosis of primary or symptomatic generalized epilepsy (including developmental and epileptic encephalopathies) or non-epileptic seizures Diagnosis of progressive CNS disease prior to implant Enrolled in another drug or device clinical trial at or within the first 2…
The NeuroPace RNS System is an implantable, closed-loop responsive neurostimulation device for drug-resistant focal epilepsy. It continuously monitors electrocorticographic activity through leads placed at one or two seizure foci in the brain and, when it detects the electrical patterns associated with seizure onset, delivers brief, typically imperceptible electrical stimulation directly to that focus to interrupt the seizure before it spreads or produces symptoms.
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