An observational study in Focal Epilepsy and Drug-resistant Focal Epilepsy, sponsored by NeuroPace. Enrolling by invitation at 1 site in United States. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by NeuroPace · Observational
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, supplemented by patient-reported outcomes captured through OM1's EDC platform.
Eligible patients are 12 through 17 years old at the time of a single RNS Model 320 implant for focal-onset epilepsy, implanted on or before December 31, 2024, with no concurrent therapeutic surgery. Patients with primary or symmetric generalized epilepsy, developmental and epileptic encephalopathies, non-epileptic seizures, progressive CNS disease, concurrent investigational drug/device trial enrollment, or status epilepticus within three months of implant are excluded. Only sites with at least three patients at least two years post-implant may contribute patients.
Beyond the co-primary endpoints, secondary objectives include the 12-month RR50 under the same 31% performance goal, annual rates of pre-specified serious adverse events of interest, rates of seizure-related adverse events versus a 365-day pre-implant baseline, and SUDEP incidence at 12 and 24 months. Supportive/exploratory endpoints include a study-specific Seizure Frequency Burden Scale (for patients whose seizure counts can't be reliably abstracted from a diary) and a clinician-assessed global impression of seizure change modeled on the CGI-I construct.
The primary effectiveness analysis assumes a true RR50 of 46%, giving \~87% power to show the lower bound of the two-sided 95% exact CI exceeds the 31% performance goal - derived from NeuroPace's Pivotal Clinical Investigation in patients aged 18-21, the closest available comparator given no adolescent-specific external control exists. Because the data are retrospective, every seizure count is graded for reliability before analysis, and sensitivity analyses include multiple imputation (MAR) and inverse probability of censoring weighting for informative attrition. Adverse events are identified solely through a pre-specified ICD-10 code list applied to each patient's EHR, not prospective reporting, consistent with FDA RWE guidance. NeuroPace sponsors the study and leads governance and regulatory submission; OM1 runs Central Site operations and data management.
243 studies on the registry are indexed under Epilepsies, Partial; 49 are open to participants now.
This study's planned enrollment of 100 is below the median of 130 across 47 observational studies indexed under Epilepsies, Partial.
Browse Epilepsies, Partial studies →NeuroPace is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Adolescents (ages 12 through 17) in the United States with drug-resistant focal epilepsy who have already been implanted with the NeuroPace RNS System (Model 320) in routine clinical practice, with implants occurring from 2018 through December 31, 2024. Patients are not drawn from a single site - they are identified from NeuroPace's commercial implant records across a variety of practice settings and geographies nationwide.
Enrollment happens through OM1's Central Site regardless of where a patient was implanted or is currently treated, so the population isn't limited to sites with dedicated research infrastructure. Recruitment lists are stratified by age band (12-14 and 15-17 years) to ensure balanced representation across the full adolescent range, and only sites with at least three patients at least two years post-implant in NeuroPace's registry are eligible to contribute patients. Enrollment continues until a target of up to 100 evaluable patients is reached.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 24 months post-implant (observational studies are permitted) Episodes of status epilepticus within 3 months prior to implant
Adolescents (ages 12 through 17) in the United States with drug-resistant focal epilepsy who have already been implanted with the NeuroPace RNS System (Model 320) in routine clinical practice, with implants occurring from 2018 through December 31, 2024.
Device: NeuroPace RNS System
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.
Rate of Serious Adverse Device Events (SADE)
Rate of Serious Adverse Device Events (SADE) - rate of serious device-related adverse events during the post-operative window, reported per 1,000 person-years with 95% CIs
Time frame: Implantation through 84 days post-implant
Responder Rate (RR50) at 24 months
Proportion of patients with ≥50% reduction in seizure frequency vs. pre-implant baseline, evaluated against a 31% performance goal (from NeuroPace's Pivotal Clinical Investigation in ages 18-21). Success requires the lower bound of the two-sided 95% exact CI to exceed 31%.
Time frame: 24 months post-implant
Responder Rate (RR50) at 12 months
Same 31% performance-goal framework as the 24-month primary
Time frame: 12 months post-implant
Annual Rate of SAEs of Interest
A pre-specified subset of SAEs of particular concern for RNS implant patients, reported descriptively.
Time frame: Time frame: 12 and 24 months post-implant
Rate of Seizure-Related Adverse Events
Serious and non-serious AEs due to seizures, compared to a pre-implant baseline rate.
Time frame: 12 and 24 months post-implant v. 365 day pre-implant baseline.
Incidence of Sudden Unexpected Death in Epilepsy
Reported descriptively (mean/median events over person-time follow-up)
Time frame: 12 and 24 months post-implant
Clinician-Assessed Impression of Seizure Change
Exploratory 5-category ordinal endpoint derived from treating-clinicians language in clinical notes, conceptually analogous to CGI-I. Reported as category distribution and proportion "much improved"/"improved"
Time frame: 3, 6, 12 and 24 months post-implant
Seizure Frequency Burden Scale
a study-specific 6-tier ordinal scale classifying EHR-documented seizure-frequency language, used for patients whose seizure-frequency language, used for patients whose seizure counts can't be reliably abstracted from a diary.
Time frame: 12 and 24 months post-implant
Patient-Assessed Impression of Seizure Change
Patient-reported perceived change in seizure control and rescue-medication use, correlated to the CA-GISC categories.
Time frame: collected via patient eCRF at point of enrollment
Plan to share: Undecided
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