RNS® System Epilepsy Post-Approval Study
- Conditions
- Epilepsy
- Interventions
- Device: RNS System
- Registration Number
- NCT02403843
- Lead Sponsor
- NeuroPace
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 375
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Evaluation RNS System A group of subjects with the RNS System implanted who elect to continue to receive RNS System responsive stimulation for the long term.
- Primary Outcome Measures
Name Time Method Neurosurgeon experience 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.
SAE rate Implant through 5 years post-implant Calculate annual SAE rates over time in the entire subject population as well as within subpopulations.
Autopsy Present data from autopsies obtained from any patient implanted with neurostimulator/leads.
Physician experience 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).
Median percentage reduction in disabling seizure 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 Through 5 years post-implant Demonstrate that stimulation programming classes have similar effects on the overall seizure frequency.
- Secondary Outcome Measures
Name Time Method Neurostimulator programming Implant through 5 years post-implant Characterize the effects of stimulation programming classes on the overall 5-year rate of SAEs and device-related non-serious AEs.
Seizure worsening 6 months post-implant through 36 months post-implant 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.
Trial Locations
- Locations (35)
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of California, Irvine
🇺🇸Irvine, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Pennsylvania State University / Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Dartmouth-Hitchcock Medical Cente
🇺🇸Lebanon, New Hampshire, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Washington Harborview Medical Center
🇺🇸Seattle, Washington, United States
Swedish Health Services
🇺🇸Seattle, Washington, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Intermountain Healthcare Research
🇺🇸Salt Lake City, Utah, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
Seton Family of Hospital
🇺🇸Austin, Texas, United States
Austin Epilepsy Care Center
🇺🇸Austin, Texas, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Norton Neuroscience Institute
🇺🇸Louisville, Kentucky, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States