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RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study
Sponsor: NeuroPace
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.
Official title: A Real-World Evidence Study to Support Label Expansion for the NeuroPace RNS System for Drug-Resistant Focal Epilepsy in Adolescent Patients in the United States
Key Details
Gender
All
Age Range
13 Years - 19 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-09-14
Completion Date
2027-05
Last Updated
2026-09-16
Healthy Volunteers
No
Interventions
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.
Locations (1)
OM1's Central Site (Virtual Site)
Waltham, Massachusetts, United States