Reviews a brain-stimulating device for teens with hard-to-treat focal epilepsy
Studies a brain implant for teens with focal epilepsy that medicines do not control.
Plain-language title generated from the registry record
Registry title: RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study
Key facts
- Where
- Waltham, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 13 and 19 years old?
Source: NCT07823465, who can take part
Where in United States
- OM1's Central Site (Virtual Site)Waltham, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NeuroPace
- Trial code
- NCT07823465
- Record updated
- 16 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.