CIP

Principal Investigator: Angela Peters
Keywords: NeuroPace , RNS System , neurostimulator , craniectomy , 5yr trial , Epilepsy Department: Neurology
IRB Number: 00097769 Co Investigator: John Rolston
Specialty: Neurosurgery, Neurology, Neurology
Sub Specialties: Epilepsy Surgery, Epilepsy, Seizures
Recruitment Status: Recruiting

Contact Information

Crystal Neate
Crystal.neate@hsc.utah.edu
8015814258

Brief Summary

5.1 Purpose

5.1.1 RNS System Epilepsy PAS 2

To follow patients prospectively over 5 years in the real-world environment to gather data on the safety and effectiveness, including long-term data on the performance and programing, of the RNS System at qualified CECs by qualified neurologists, epileptologist, and neurosurgeons trained on the RNS System.

5.1.2 RNS System Epilepsy PAS3

To follow patients prospectively over 5 years in the real-world environment to gather data on the safety and effectiveness, including long-term data on the performance and programing, of the RNS System at qualified CECs by qualified neurologists, epileptologist, and neurosurgeons trained on the RNS System.

5.1.3 RNS System Epilepsy PAS4

To follow patient prospectively in the real-world environment to gather data on the implant, explant, reimplantation, and revision of the neurostimulator and lead(s) at qualified CECs by qualified neurosurgeons trained on the RNS System.

5.1.4 RNS System Epilepsy PAS5

To characterize autopsy data for deaths which occur in patients treated with the RNS System.

5.2 Objectives

5.2.1 Primary objectives

  5.2.1.1 Safety objectives

   5.2.1.1.1 SAE rate- entire population (Obj 2a) Calculate the annual SAE rate over time in patients treated with the RNS System.

   5.2.1.1.2 SAE rate- subpopulations (Obj 3a) Calculate the annual SAE rate over time in subpopulations of subjects treated with RNS System.

   5.2.1.1.3 Neurosurgeon experience(Obj 3e) Demonstrate that there is no difference in safety in the 6-week perioperative period based on the experience of NeuroPace qualified and trained implanting physicians.

   5.2.1.1.4 Physician experience (Obj 3f) Demonstrate that there is no difference in safety 1 year post-implant based on the experience of NeuroPace qualified and trained treating physicians and CECs.

   5.2.1.1.5 Product use- surgical procedures (Obj 4a) Present the incidence and number of AEs related to surgical procedures associated with implant, explant, reimplantation, and revision of the neurostimulator and lead(s).

5.2.2 Secondary objectives

  5.2.2.1 Safety objectives

   5.2.2.1.1 Seizure worsening-entire population (Obj 2c) Demonstrate that there is not worsening in disabling seizures over time in patients treated with the RNS System.

   5.2.2.1.2 Seizure worsening- subpopulations (Obj 3c) Assess the sustained effect on disabling seizure frequency over time in subpopulations of subjects treated with the RNS System.

   5.2.2.1.3 Neurostimulator programming (Obj 3h) Characterize the effects of stimulation programing classes on the overall 5-year rate of SAEs and device-related non-serious AEs.

   5.2.2.1.4 other objectives

     5.2.2.2.1 Neurostimulator batter longevity(Obj 2d) Characterize the clinically observed batter longevity over time and in relation to therapy load in patients treated with the RNS System.

5.2.3 Additional objectives

Characterize, describe, and evaluate the following topics within patients treated with the RNS System for: (a) the entire population (Obj 2e) and (b) subpopulations (Obj 3d):

-Patient characteristics

-AEs of particular relevance

  SAE and non-serious AE rates in the 6-week perioperative period

  SAE and non-serious AE rates throughout the study related to: intracranial hemorrhage, seizure-associated injury requiring medical attention, new more severe disabling seizure type, the neurostimulator or leads, suicidality, or adjudicated SUDEP

-All-cause mortality

-AED use

-Subject disposition

-RNS System explant/revision

-SUDEP rate

-Median percentage change

-Responder rate

-Seizure frequency

  

 

Inclusion Criteria

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 (Table 1)

-Scheduled for RNS implantation

Exclusion Criteria

Exclusion Criteria

-Subject was diagnosed with primarily generalized seizures

-Subject is participating in a therapeutic investigational drug

-Subject has an implanted medical device that delivers electrical energy to the brain

-Subject was  treated with vagus nerve stimulator within the last three months (90days)

-Subject requires MR imaging

-Subject is pregnant