RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study

NCT07823465 | Enrolling By Invitation FDA Device

• 1 other identifier: AURORA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Focal Epilepsy; Drug-resistant Focal Epilepsy

Keywords

Responsive neurostimulation; RNS System; adolescent epilepsy; real-world evidence

Outcome Measures

Primary Outcomes (2)

• 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

  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%.

  24 months post-implant

Secondary Outcomes (5)

• Responder Rate (RR50) at 12 months

  12 months post-implant

• Annual Rate of SAEs of Interest

  Time frame: 12 and 24 months post-implant

• Rate of Seizure-Related Adverse Events

  12 and 24 months post-implant v. 365 day pre-implant baseline.

• Incidence of Sudden Unexpected Death in Epilepsy

  12 and 24 months post-implant

• Clinician-Assessed Impression of Seizure Change

  3, 6, 12 and 24 months post-implant

Other Outcomes (2)

• Seizure Frequency Burden Scale

  12 and 24 months post-implant

• Patient-Assessed Impression of Seizure Change

  collected via patient eCRF at point of enrollment

Study Arms (1)

Cohort

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

Interventions

NeuroPace RNS System DEVICE

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.

Cohort

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroPace: lead
• OM1, Inc.: collaborator

Study Sites (1)

OM1's Central Site (Virtual Site)

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ashish Deshpande, MD

  OM1, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

US (1)