Focal EpilepsyAURORANCT07823465
RNS System for Drug-Resistant Focal Epilepsy in Adolescents: A Real-World Study
An observational study of Focal Epilepsy and Drug-resistant Focal Epilepsy, run by NeuroPace at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Focal Epilepsy, Drug-resistant Focal Epilepsy
- What is being tested?
- NeuroPace RNS System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to May 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OM1's Central Site (Virtual Site)
Waltham, Massachusetts, 02451
About this study
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
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.
Read the detailed description
AURORA is a retrospective, observational, real-world evidence study run through OM1's Central Site model rather than a prospective trial infrastructure. NeuroPace identifies potentially eligible patients from its existing commercial implant records, stratified by age band (12-14 and 15-17 years) to ensure balanced representation, and nurse navigators conduct an initial prescreen before referring interested patients to OM1 for full informed consent, assent, and HIPAA authorization. EHR data are retrieved from each patient's own treating institutions into the OM1 Origin data warehouse, supplemented by patient-reported outcomes captured through OM1's EDC platform.
Eligible patients are 12 through 17 years old at the time of a single RNS Model 320 implant for focal-onset epilepsy, implanted on or before December 31, 2024, with no concurrent therapeutic surgery. Patients with primary or symmetric generalized epilepsy, developmental and epileptic encephalopathies, non-epileptic seizures, progressive CNS disease, concurrent investigational drug/device trial enrollment, or status epilepticus within three months of implant are excluded. Only sites with at least three patients at least two years post-implant may contribute patients.
Beyond the co-primary endpoints, secondary objectives include the 12-month RR50 under the same 31% performance goal, annual rates of pre-specified serious adverse events of interest, rates of seizure-related adverse events versus a 365-day pre-implant baseline, and SUDEP incidence at 12 and 24 months. Supportive/exploratory endpoints include a study-specific Seizure Frequency Burden Scale (for patients whose seizure counts can't be reliably abstracted from a diary) and a clinician-assessed global impression of seizure change modeled on the CGI-I construct.
The primary effectiveness analysis assumes a true RR50 of 46%, giving ~87% power to show the lower bound of the two-sided 95% exact CI exceeds the 31% performance goal - derived from NeuroPace's Pivotal Clinical Investigation in patients aged 18-21, the closest available comparator given no adolescent-specific external control exists. Because the data are retrospective, every seizure count is graded for reliability before analysis, and sensitivity analyses include multiple imputation (MAR) and inverse probability of censoring weighting for informative attrition. Adverse events are identified solely through a pre-specified ICD-10 code list applied to each patient's EHR, not prospective reporting, consistent with FDA RWE guidance. NeuroPace sponsors the study and leads governance and regulatory submission; OM1 runs Central Site operations and data management.
- Conditions
- Focal Epilepsy, Drug-resistant Focal Epilepsy
- Being tested
- NeuroPace RNS System
- Keywords
- Responsive neurostimulation, RNS System, adolescent epilepsy, real-world evidence
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroPace RNS SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NeuroPace RNS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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%.
Measured: 24 months post-implant
Secondary outcomes (5)
Responder Rate (RR50) at 12 months
Same 31% performance-goal framework as the 24-month primary
Measured: 12 months post-implant
Annual Rate of SAEs of Interest
A pre-specified subset of SAEs of particular concern for RNS implant patients, reported descriptively.
Measured: Time frame: 12 and 24 months post-implant
Rate of Seizure-Related Adverse Events
Serious and non-serious AEs due to seizures, compared to a pre-implant baseline rate.
Measured: 12 and 24 months post-implant v. 365 day pre-implant baseline.
Incidence of Sudden Unexpected Death in Epilepsy
Reported descriptively (mean/median events over person-time follow-up)
Measured: 12 and 24 months post-implant
Clinician-Assessed Impression of Seizure Change
Exploratory 5-category ordinal endpoint derived from treating-clinicians language in clinical notes, conceptually analogous to CGI-I. Reported as category distribution and proportion "much improved"/"improved"
Measured: 3, 6, 12 and 24 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- NeuroPace
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OM1, Inc.
- Responsible party
- Sponsor
- Investigators
- Ashish Deshpande, MD, Principal investigator, OM1, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823465
- Sponsor's protocol ID
- AURORA
- Acronym
- AURORA
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07823465
- Acronym / sponsor ID
- AURORA / AURORA
- Conditions
- Focal Epilepsy, Drug-resistant Focal Epilepsy
- Keywords
- Responsive neurostimulation, RNS System, adolescent epilepsy, real-world evidence
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NeuroPaceIndustry (pharma, biotech, devices)
- Collaborators
- OM1, Inc.
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
AURORA is a retrospective, observational, real-world evidence study run through OM1's Central Site model rather than a prospective trial infrastructure. NeuroPace identifies potentially eligible patients from its existing commercial implant records, stratified by age band (12-14 and 15-17 years) to ensure balanced representation, and nurse navigators conduct an initial prescreen before referring interested patients to OM1 for full informed consent, assent, and HIPAA authorization. EHR data are retrieved from each patient's own treating institutions into the OM1 Origin data warehouse, supplemented by patient-reported outcomes captured through OM1's EDC platform.
Eligible patients are 12 through 17 years old at the time of a single RNS Model 320 implant for focal-onset epilepsy, implanted on or before December 31, 2024, with no concurrent therapeutic surgery. Patients with primary or symmetric generalized epilepsy, developmental and epileptic encephalopathies, non-epileptic seizures, progressive CNS disease, concurrent investigational drug/device trial enrollment, or status epilepticus within three months of implant are excluded. Only sites with at least three patients at least two years post-implant may contribute patients.
Beyond the co-primary endpoints, secondary objectives include the 12-month RR50 under the same 31% performance goal, annual rates of pre-specified serious adverse events of interest, rates of seizure-related adverse events versus a 365-day pre-implant baseline, and SUDEP incidence at 12 and 24 months. Supportive/exploratory endpoints include a study-specific Seizure Frequency Burden Scale (for patients whose seizure counts can't be reliably abstracted from a diary) and a clinician-assessed global impression of seizure change modeled on the CGI-I construct.
The primary effectiveness analysis assumes a true RR50 of 46%, giving ~87% power to show the lower bound of the two-sided 95% exact CI exceeds the 31% performance goal - derived from NeuroPace's Pivotal Clinical Investigation in patients aged 18-21, the closest available comparator given no adolescent-specific external control exists. Because the data are retrospective, every seizure count is graded for reliability before analysis, and sensitivity analyses include multiple imputation (MAR) and inverse probability of censoring weighting for informative attrition. Adverse events are identified solely through a pre-specified ICD-10 code list applied to each patient's EHR, not prospective reporting, consistent with FDA RWE guidance. NeuroPace sponsors the study and leads governance and regulatory submission; OM1 runs Central Site operations and data management.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Device: NeuroPace RNS SystemAdolescents (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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroPace RNS SystemThe 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. | Device | Cohort |
Primary outcome
Rate of Serious Adverse Device Events (SADE)
Time frame: 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
Time frame: 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%.
5 secondary outcomes
Responder Rate (RR50) at 12 months
Time frame: 12 months post-implant
Annual Rate of SAEs of Interest
Time frame: Time frame: 12 and 24 months post-implant
Rate of Seizure-Related Adverse Events
Time frame: 12 and 24 months post-implant v. 365 day pre-implant baseline.
Incidence of Sudden Unexpected Death in Epilepsy
Time frame: 12 and 24 months post-implant
Clinician-Assessed Impression of Seizure Change
Time frame: 3, 6, 12 and 24 months post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashish Deshpande, MD principal investigator
OM1, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Epilepsy and Drug-resistant Focal Epilepsy, run by NeuroPace at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Serious Adverse Device Events (SADE) (time frame: Implantation through 84 days post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.