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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 : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
NeuroPace

Tracking Information
First Submitted Date March 26, 2015
First Posted Date March 31, 2015
Last Update Posted Date January 21, 2020
Study Start Date April 2015
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2015)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02403843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 26, 2015)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 26, 2015)
Neurostimulator battery longevity
Characterize the clinically observed battery longevity over time and in relation to therapy load in patients treated with the RNS System.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title RNS® System Epilepsy PAS
Official Title RNS® System Post-Approval Study in Epilepsy
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epilepsy
Intervention 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.
Study Groups/Cohorts Evaluation
A group of subjects with the RNS System implanted who elect to continue to receive RNS System responsive stimulation for the long term.
Intervention: Device: RNS System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: March 26, 2015)
375
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02403843
Other Study ID Numbers NP10012
PMA100026 ( Other Identifier: United States FDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NeuroPace
Study Sponsor NeuroPace
Collaborators Not Provided
Investigators
Study Director: Martha J Morrell, MD NeuroPace, Inc.
PRS Account NeuroPace
Verification Date January 2020