SHS_543095 GWIR CNRP 15136

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.

Inclusion Criteria:

•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

Exclusion Criteria:

•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
Ryder Gwinn, M.D.
Morgan Alexander
  • Swedish Medical Center