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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

Official Title

RNS® System Post-Approval Study in Epilepsy

Details

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.

Keywords

Epilepsy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subject is 18 years of age or older
  • Subject has frequent, disabling seizures (SPS-motor, CPS, and/or secondarily generalized seizures)
  • Subject has failed treatment with a minimum of 2 AEDs
  • Subject has undergone diagnostic testing that has identified no more than 2 epileptogenic foci
  • 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 CAN'T join if...

  • Subject was diagnosed with primarily generalized seizures
  • Subject is participating in a therapeutic investigational drug or device study
  • Subject has an implanted medical device that delivers electrical energy to the brain
  • Subject was treated with a VNS within the last three months (90 days)
  • Subject requires MR imaging
  • Subject is pregnant

Locations

  • California Pacific Medical Center
    San Francisco, California, 94115, USA

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
NeuroPace
ID
NCT02403843
Study Type
Observational
Last Updated
September 2016