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RNS® System Epilepsy PAS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02403843
Recruitment Status : Enrolling by invitation
First Posted : March 31, 2015
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
NeuroPace

Brief 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.

Condition or disease Intervention/treatment
Epilepsy Device: RNS System

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.

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Study Type : Observational
Estimated Enrollment : 375 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RNS® System Post-Approval Study in Epilepsy
Study Start Date : April 2015
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

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

  6. 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.

  7. 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 :
  1. 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.

  2. 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:
  1. Neurostimulator battery longevity
    Characterize the clinically observed battery longevity over time and in relation to therapy load in patients treated with the RNS System.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403843


Locations
Hide Hide 28 study locations
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United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California, Irvine
Irvine, California, United States, 92868
University of Southern California
Los Angeles, California, United States, 90032
Stanford University
Palo Alto, California, United States, 94304
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, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
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, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
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, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44193
United States, Pennsylvania
Pennsylvania State University / Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
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, Texas
Seton Family of Hospital
Austin, Texas, United States, 78701
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9036
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132-5901
Intermountain Healthcare Research
Salt Lake City, Utah, United States, 84157
United States, Washington
Swedish Health Services
Seattle, Washington, United States, 98122
Sponsors and Collaborators
NeuroPace
Investigators
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Study Director: Martha J Morrell, MD NeuroPace, Inc.

Publications:

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Responsible Party: NeuroPace
ClinicalTrials.gov Identifier: NCT02403843    
Other Study ID Numbers: NP10012
PMA100026 ( Other Identifier: United States FDA )
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases