NCT07823465Enrolling by invitation
RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- 14 Sept 2026
- Primary completion date
- Feb 2027
- Lead sponsor
- NeuroPace
- Diseases
- Epilepsy
- NCT number
- NCT07823465
What you commit to
- Study type: Observational
- Planned participants: 100
- From 14 Sept 2026 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 13 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OM1's Central Site (Virtual Site) Coordinator of this site? Confirm its status | Waltham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.