Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

RNS® System Epilepsy PAS

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
NeuroPace
ClinicalTrials.gov Identifier:
NCT02403843
First received: March 26, 2015
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Epilepsy
Device: RNS System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: RNS® System Post-Approval Study in Epilepsy

Resource links provided by NLM:


Further study details as provided by NeuroPace:

Primary Outcome Measures:
  • SAE rate [ Time Frame: Implant through 5 years post-implant ]
    Calculate annual SAE rates over time in the entire subject population as well as within subpopulations.

  • Neurosurgeon experience [ Time Frame: Implant through 41 days post-implant ]
    Demonstrate there is no difference in safety in 6-week perioperative period based on the experience of NeuroPace qualified and trained implanting physicians.

  • Physician experience [ Time Frame: Implant through 1 year post-implant ]
    Demonstrate there is no difference in safety 1 year post-implant based on experience of NeuroPace qualified and trained treating physicians and Comprehensive Epilepsy Centers.

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

  • Autopsy
    Present data from autopsies obtained from any patient implanted with neurostimulator/leads.

  • Median percentage reduction in disabling seizure [ Time Frame: Pre-implant (retrospective data) compared to 30 to 36 months post-implant ]
    Demonstrate that the median percentage reduction in disabling seizures over time in the entire subject population is comparable to the median percentage reduction in disabling seizures over time in the LTT study. Characterize the median percentage reduction in disabling seizures over time within subpopulations.

  • Neurostimulator programming [ Time Frame: Through 5 years post-implant ]
    Demonstrate that stimulation programming classes have similar effects on the overall seizure frequency.


Secondary Outcome Measures:
  • Seizure worsening [ Time Frame: 6 months post-implant through 36 months post-implant ]
    Demonstrate that there is not a worsening in disabling seizures over time in the entire subject population. Assess the sustained effect on disabling seizure frequency over time within subpopulations.

  • Neurostimulator programming [ Time Frame: Implant through 5 years post-implant ]
    Characterize the effects of stimulation programming classes on the overall 5-year rate of SAEs and device-related non-serious AEs.


Other Outcome Measures:
  • Neurostimulator battery longevity
    Characterize the clinically observed battery longevity over time and in relation to therapy load in patients treated with the RNS System.


Estimated Enrollment: 375
Study Start Date: April 2015
Estimated Study Completion Date: May 2023
Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Evaluation
A group of subjects with the RNS System implanted who elect to continue to receive RNS System responsive stimulation for the long term.
Device: RNS System
The RNS System provides closed loop responsive brain stimulation. In response to detection of previously identified electrocorticographic activity, the neurostimulator delivers stimulation to the seizure foci by way of the leads to interrupt the activity before the patient experiences clinical seizures. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02403843

Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, New Hampshire
Dartmouth-Hitchcock Medical Cente
Lebanon, New Hampshire, United States, 03756
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38105
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Washington
Swedish Health Services
Seattle, Washington, United States, 98122
Sponsors and Collaborators
NeuroPace
Investigators
Study Director: Martha J Morrell, MD NeuroPace, Inc.
  More Information

Publications:

Responsible Party: NeuroPace
ClinicalTrials.gov Identifier: NCT02403843     History of Changes
Other Study ID Numbers: NP10012
PMA100026 ( Other Identifier: United States FDA )
Study First Received: March 26, 2015
Last Updated: September 20, 2016

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 25, 2017