RNS® System Epilepsy Post-Approval Study

Completed

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT02403843

Run by

NeuroPace

People needed

345

Starts

2015-06-01

Expected to finish

2026-01-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• University of California, Irvine — Irvine, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California, San Francisco — San Francisco, California, 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
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Norton Neuroscience Institute — Louisville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Cente — Lebanon, New Hampshire, United States
• NYU Langone Medical Center — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Pennsylvania State University / Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.