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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 : October 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Study Design

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
U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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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

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


  Show 23 Study Locations
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 )
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

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