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

Contact Information

Lilly Fagatele
Lilly.Fagatele@hsc.utah.edu
801-585-9266

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

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 able to maintain a seizure diary alone or with the assistance of a competent individual
  • Subject is able to attend clnic appointments in accordance with the study schedule (Table 1)

Exclusion Criteria

Exclusion Criteria

Per clinician assessment, treatment with the RNS System is contraindicated based on current RNS System labeling. or 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 folloiwng additional study related exclusion criteria:

-Subject is participating in a therapeutic investigational drug or device study

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

-Subject is pregnant