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.
Study summary
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.
Eligibility
Sex
ALL
Min age
13 Years
Max age
19 Years
Healthy volunteers
No
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 24 months post-implant (observational studies are permitted) Episodes of status epilepticus within 3 months prior to implant
Primary outcome measure(s)
Rate of Serious Adverse Device Events (SADE) — Implantation through 84 days post-implant 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
Responder Rate (RR50) at 24 months — 24 months post-implant 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%.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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