EpilepsyPASNCT02403843
RNS® System Epilepsy Post-Approval Study
An observational study of Epilepsy, run by NeuroPace at 35 sites in United States.
Trial summary
The purpose of the study is to follow patients with partial onset seizures prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- RNS System
- Type of treatment
- Medical device
- How many people
- 345 participants
- Where
- 35 sitesUnited States
- Study dates
- Jun 2015to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures.
Who may be able to join
- A clinical decision to treat the patient with the RNS System in accordance with its approved indication for use has been made prior to enrollment in the study. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
- This post-approval study also has the following additional study related inclusion criteria:
- Subject or legal guardian is able to provide appropriate consent to participate
- Subject is able to maintain a seizure diary alone or with the assistance of a competent individual
- Subject is able to attend clinic appointments in accordance with the study schedule
Who cannot join
- Per clinician assessment, treatment with the RNS System is contraindicated based on current RNS System labeling. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
- This post-approval study has the following additional study related exclusion criteria:
- Subject is participating in a therapeutic investigational drug or device study
- Subject was treated with a VNS within the last three months (90 days)
- Subject is pregnant
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Emory University
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
Seton Family of Hospital
Austin, Texas, 78701
Austin Epilepsy Care Center
Austin, Texas, 78758
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Rush University Medical Center
Chicago, Illinois, 60612
The Cleveland Clinic Foundation
Cleveland, Ohio, 44193
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9036
Spectrum Health
Grand Rapids, Michigan, 49503
Pennsylvania State University / Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
The University of Texas Health Science Center at Houston
Houston, Texas
Indiana University
Indianapolis, Indiana, 46202
University of California, Irvine
Irvine, California, 92868
Dartmouth-Hitchcock Medical Cente
Lebanon, New Hampshire, 03756
University of Kentucky
Lexington, Kentucky, 40506
University of Southern California
Los Angeles, California, 90032
University of California, Los Angeles
Los Angeles, California, 90095
Norton Neuroscience Institute
Louisville, Kentucky, 40241
University of Wisconsin-Madison
Madison, Wisconsin, 53705
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
Vanderbilt University
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06520
NYU Langone Medical Center
New York, New York, 10016
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Stanford University
Palo Alto, California, 94304
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Utah
Salt Lake City, Utah, 84132-5901
Intermountain Healthcare Research
Salt Lake City, Utah, 84157
University of California, San Francisco
San Francisco, California, 94143
University of Washington Harborview Medical Center
Seattle, Washington, 98104
Swedish Health Services
Seattle, Washington, 98122
University of South Florida
Tampa, Florida
About this study
Official title: RNS® System Post-Approval Study in Epilepsy
The purpose of the study is to follow patients with partial onset seizures prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.
Read the detailed description
NeuroPace, Inc. is sponsoring a post-approval study (PAS) of the RNS System device. The RNS System is the first FDA-approved closed loop responsive neurostimulator designed to reduce the frequency of seizures in individuals with partial onset seizures.
The RNS System Epilepsy PAS is a 5 year, non-randomized, open-label, multi-center prospective observational study. Data regarding safety and efficacy are collected at enrollment and periodically throughout the 5-year study.
The study is designed to assess the long-term safety and effectiveness of the RNS System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures).
Data from the RNS System Epilepsy PAS will be used to calculate long-term SAE rates, median percent change in seizure frequency (from pre-implant retrospective data), as well as other safety and effectiveness endpoints.
- Conditions
- Epilepsy
- Being tested
- RNS System
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNS SystemDevice
The RNS System provides closed loop responsive brain stimulation. In response to detection of previously identified electrocorticographic activity, the neurostimulator delivers stimulation to the seizure foci by way of the leads to interrupt the activity before the patient experiences clinical seizures. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation | A group of subjects with the RNS System implanted who elect to continue to receive RNS System responsive stimulation for the long term. Receives: Device: RNS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAE rate
Calculate annual SAE rates over time in the entire subject population as well as within subpopulations.
Measured: Implant through 5 years post-implant
Neurosurgeon experience
Demonstrate there is no difference in safety in 6-week perioperative period based on the experience of NeuroPace qualified and trained implanting physicians.
Measured: Implant through 41 days post-implant
Physician experience
Demonstrate there is no difference in safety 1 year post-implant based on experience of NeuroPace qualified and trained treating physicians and Comprehensive Epilepsy Centers.
Measured: Implant through 1 year post-implant
Product use - surgical procedures
Present the incidence and number of AEs related to surgical procedures associated with implant, explant, reimplantation, and revision of the neurostimulator and lead(s).
Autopsy
Present data from autopsies obtained from any patient implanted with neurostimulator/leads.
Median percentage reduction in disabling seizure
Demonstrate that the median percentage reduction in disabling seizures over time in the entire subject population is comparable to the median percentage reduction in disabling seizures over time in the LTT study. Characterize the median percentage reduction in disabling seizures over time within subpopulations.
Measured: Pre-implant (retrospective data) compared to 30 to 36 months post-implant
Neurostimulator programming
Demonstrate that stimulation programming classes have similar effects on the overall seizure frequency.
Measured: Through 5 years post-implant
Secondary outcomes (2)
Seizure worsening
Demonstrate that there is not a worsening in disabling seizures over time in the entire subject population. Assess the sustained effect on disabling seizure frequency over time within subpopulations.
Measured: 6 months post-implant through 36 months post-implant
Neurostimulator programming
Characterize the effects of stimulation programming classes on the overall 5-year rate of SAEs and device-related non-serious AEs.
Measured: Implant through 5 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2023
- Study completionJan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Prospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroPace
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martha J Morrell, MD, Study director, NeuroPace, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403843
- Sponsor's protocol ID
- NP10012
- Other IDs
- PMA100026
- Acronym
- PAS
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2015
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bergey GK, Morrell MJ, Mizrahi EM, Goldman A, King-Stephens D, Nair D, Srinivasan S, Jobst B, Gross RE, Shields DC, Barkley G, Salanova V, Olejniczak P, Cole A, Cash SS, Noe K, Wharen R, Worrell G, Murro AM, Edwards J, Duchowny M, Spencer D, Smith M, Geller E, Gwinn R, Skidmore C, Eisenschenk S, Berg M, Heck C, Van Ness P, Fountain N, Rutecki P, Massey A, O'Donovan C, Labar D, Duckrow RB, Hirsch LJ, Courtney T, Sun FT, Seale CG. Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology. 2015 Feb 24;84(8):810-7. doi: 10.1212/WNL.0000000000001280. Epub 2015 Jan 23.
PubMed 25616485Heck CN, King-Stephens D, Massey AD, Nair DR, Jobst BC, Barkley GL, Salanova V, Cole AJ, Smith MC, Gwinn RP, Skidmore C, Van Ness PC, Bergey GK, Park YD, Miller I, Geller E, Rutecki PA, Zimmerman R, Spencer DC, Goldman A, Edwards JC, Leiphart JW, Wharen RE, Fessler J, Fountain NB, Worrell GA, Gross RE, Eisenschenk S, Duckrow RB, Hirsch LJ, Bazil C, O'Donovan CA, Sun FT, Courtney TA, Seale CG, Morrell MJ. Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial. Epilepsia. 2014 Mar;55(3):432-41. doi: 10.1111/epi.12534. Epub 2014 Feb 22.
PubMed 24621228Morrell MJ; RNS System in Epilepsy Study Group. Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology. 2011 Sep 27;77(13):1295-304. doi: 10.1212/WNL.0b013e3182302056. Epub 2011 Sep 14.
PubMed 21917777Eliashiv D, Rao VR, Jobst BC, Szaflarski JP, Rolston JD, Kaye LC, Ganguly TM, Bullinger K, Dugan PC, Burdette DE, Peters AY, Sheikh A, Haas KF, Nair DR, Mnatsakanyan L, Quraishi IH, Bensalem-Owen MK; RNS System PAS Study; Doherty MJ, Razavi B, Fisher TL, Skidmore C, Modur PN, Constantino TM, Salanova V, Cole AJ, Taraschenko O, Rivera-Cruz A, Wheless JW, Tandon N, Balabanov A, Aboumatar S, Fried I, Drees C, Shin HW, Jaisani Z, MacIver SE, Patra SE, Chang EF, Willie JT, Gwinn R, Stoub T, Stern JM, Crabtree T, Seale CG, McFadden SC, Norman JF, Johnson L, Morrell MJ. Postapproval Study for Brain-Responsive Neurostimulation for Drug-Resistant Focal Epilepsy: Three-Year Efficacy and Interim Safety Results. Neurology. 2026 May 12;106(9):e214875. doi: 10.1212/WNL.0000000000214875. Epub 2026 Apr 24.
PubMed 42030518
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNS® System Post-Approval Study in Epilepsy
- ClinicalTrials.gov ID
- NCT02403843
- Acronym / sponsor ID
- PAS / NP10012
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- NeuroPaceIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Jan 2026 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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 purpose of the study is to follow patients with partial onset seizures prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.
Detailed description
NeuroPace, Inc. is sponsoring a post-approval study (PAS) of the RNS System device. The RNS System is the first FDA-approved closed loop responsive neurostimulator designed to reduce the frequency of seizures in individuals with partial onset seizures.
The RNS System Epilepsy PAS is a 5 year, non-randomized, open-label, multi-center prospective observational study. Data regarding safety and efficacy are collected at enrollment and periodically throughout the 5-year study.
The study is designed to assess the long-term safety and effectiveness of the RNS System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures).
Data from the RNS System Epilepsy PAS will be used to calculate long-term SAE rates, median percent change in seizure frequency (from pre-implant retrospective data), as well as other safety and effectiveness endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation | – | Device: RNS SystemA group of subjects with the RNS System implanted who elect to continue to receive RNS System responsive stimulation for the long term. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures.
Key inclusion criteria (5 listed)
- A clinical decision to treat the patient with the RNS System in accordance with its approved indication for use has been made prior to enrollment in the study. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
- This post-approval study also has the following additional study related inclusion criteria:
- Subject or legal guardian is able to provide appropriate consent to participate
- Subject is able to maintain a seizure diary alone or with the assistance of a competent individual
- Subject is able to attend clinic appointments in accordance with the study schedule
Key exclusion criteria (5 listed)
- Per clinician assessment, treatment with the RNS System is contraindicated based on current RNS System labeling. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).
- Subject is participating in a therapeutic investigational drug or device study
- Subject was treated with a VNS within the last three months (90 days)
- Subject is pregnant
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 |
|---|---|---|
| RNS SystemThe RNS System provides closed loop responsive brain stimulation. In response to detection of previously identified electrocorticographic activity, the neurostimulator delivers stimulation to the seizure foci by way of the leads to interrupt the activity before the patient experiences clinical seizures. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day. | Device | Evaluation |
Primary outcome
SAE rate
Time frame: Implant through 5 years post-implant
Calculate annual SAE rates over time in the entire subject population as well as within subpopulations.
Neurosurgeon experience
Time frame: Implant through 41 days post-implant
Demonstrate there is no difference in safety in 6-week perioperative period based on the experience of NeuroPace qualified and trained implanting physicians.
Physician experience
Time frame: Implant through 1 year post-implant
Demonstrate there is no difference in safety 1 year post-implant based on experience of NeuroPace qualified and trained treating physicians and Comprehensive Epilepsy Centers.
Product use - surgical procedures
Present the incidence and number of AEs related to surgical procedures associated with implant, explant, reimplantation, and revision of the neurostimulator and lead(s).
Autopsy
Present data from autopsies obtained from any patient implanted with neurostimulator/leads.
Median percentage reduction in disabling seizure
Time frame: Pre-implant (retrospective data) compared to 30 to 36 months post-implant
Demonstrate that the median percentage reduction in disabling seizures over time in the entire subject population is comparable to the median percentage reduction in disabling seizures over time in the LTT study. Characterize the median percentage reduction in disabling seizures over time within subpopulations.
Neurostimulator programming
Time frame: Through 5 years post-implant
Demonstrate that stimulation programming classes have similar effects on the overall seizure frequency.
2 secondary outcomes
Seizure worsening
Time frame: 6 months post-implant through 36 months post-implant
Neurostimulator programming
Time frame: Implant through 5 years post-implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 25616485Bergey GK, Morrell MJ, Mizrahi EM, Goldman A, King-Stephens D, Nair D, Srinivasan S, Jobst B, Gross RE, Shields DC, Barkley G, Salanova V, Olejniczak P, Cole A, Cash SS, Noe K, Wharen R, Worrell G, Murro AM, Edwards J, Duchowny M, Spencer D, Smith M, Geller E, Gwinn R, Skidmore C, Eisenschenk S, Berg M, Heck C, Van Ness P, Fountain N, Rutecki P, Massey A, O'Donovan C, Labar D, Duckrow RB, Hirsch LJ, Courtney T, Sun FT, Seale CG. Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology. 2015 Feb 24;84(8):810-7. doi: 10.1212/WNL.0000000000001280. Epub 2015 Jan 23.
- Background: PubMed 24621228Heck CN, King-Stephens D, Massey AD, Nair DR, Jobst BC, Barkley GL, Salanova V, Cole AJ, Smith MC, Gwinn RP, Skidmore C, Van Ness PC, Bergey GK, Park YD, Miller I, Geller E, Rutecki PA, Zimmerman R, Spencer DC, Goldman A, Edwards JC, Leiphart JW, Wharen RE, Fessler J, Fountain NB, Worrell GA, Gross RE, Eisenschenk S, Duckrow RB, Hirsch LJ, Bazil C, O'Donovan CA, Sun FT, Courtney TA, Seale CG, Morrell MJ. Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial. Epilepsia. 2014 Mar;55(3):432-41. doi: 10.1111/epi.12534. Epub 2014 Feb 22.
- Background: PubMed 21917777Morrell MJ; RNS System in Epilepsy Study Group. Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology. 2011 Sep 27;77(13):1295-304. doi: 10.1212/WNL.0b013e3182302056. Epub 2011 Sep 14.
- Derived from this study: PubMed 42030518Eliashiv D, Rao VR, Jobst BC, Szaflarski JP, Rolston JD, Kaye LC, Ganguly TM, Bullinger K, Dugan PC, Burdette DE, Peters AY, Sheikh A, Haas KF, Nair DR, Mnatsakanyan L, Quraishi IH, Bensalem-Owen MK; RNS System PAS Study; Doherty MJ, Razavi B, Fisher TL, Skidmore C, Modur PN, Constantino TM, Salanova V, Cole AJ, Taraschenko O, Rivera-Cruz A, Wheless JW, Tandon N, Balabanov A, Aboumatar S, Fried I, Drees C, Shin HW, Jaisani Z, MacIver SE, Patra SE, Chang EF, Willie JT, Gwinn R, Stoub T, Stern JM, Crabtree T, Seale CG, McFadden SC, Norman JF, Johnson L, Morrell MJ. Postapproval Study for Brain-Responsive Neurostimulation for Drug-Resistant Focal Epilepsy: Three-Year Efficacy and Interim Safety Results. Neurology. 2026 May 12;106(9):e214875. doi: 10.1212/WNL.0000000000214875. Epub 2026 Apr 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Martha J Morrell, MD study director
NeuroPace, Inc.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by NeuroPace at 35 sites 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SAE rate (time frame: Implant through 5 years post-implant). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02403843, which also lists 4 linked publications.
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 9 Apr 2026.