Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
375 participants
OBSERVATIONAL
2015-06-30
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Evaluation
A group of subjects with the RNS System implanted who elect to continue to receive RNS System responsive stimulation for the long term.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 is participating in a therapeutic investigational drug or device study
* Subject was treated with a VNS within the last three months (90 days)
* Subject is pregnant
18 Years
ALL
No
Sponsors
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NeuroPace
INDUSTRY
Responsible Party
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Principal Investigators
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Martha J Morrell, MD
Role: STUDY_DIRECTOR
NeuroPace, Inc.
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
University of California, Irvine
Irvine, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Neuroscience Institute
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Spectrum Health
Grand Rapids, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Cente
Lebanon, New Hampshire, United States
NYU Langone Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Pennsylvania State University / Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Seton Family of Hospital
Austin, Texas, United States
Austin Epilepsy Care Center
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Intermountain Healthcare Research
Salt Lake City, Utah, United States
University of Washington Harborview Medical Center
Seattle, Washington, United States
Swedish Health Services
Seattle, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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References
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Bergey GK, Morrell MJ, Mizrahi EM, Goldman A, King-Stephens D, Nair D, Srinivasan S, Jobst B, Gross RE, Shields DC, Barkley G, Salanova V, Olejniczak P, Cole A, Cash SS, Noe K, Wharen R, Worrell G, Murro AM, Edwards J, Duchowny M, Spencer D, Smith M, Geller E, Gwinn R, Skidmore C, Eisenschenk S, Berg M, Heck C, Van Ness P, Fountain N, Rutecki P, Massey A, O'Donovan C, Labar D, Duckrow RB, Hirsch LJ, Courtney T, Sun FT, Seale CG. Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology. 2015 Feb 24;84(8):810-7. doi: 10.1212/WNL.0000000000001280. Epub 2015 Jan 23.
Heck CN, King-Stephens D, Massey AD, Nair DR, Jobst BC, Barkley GL, Salanova V, Cole AJ, Smith MC, Gwinn RP, Skidmore C, Van Ness PC, Bergey GK, Park YD, Miller I, Geller E, Rutecki PA, Zimmerman R, Spencer DC, Goldman A, Edwards JC, Leiphart JW, Wharen RE, Fessler J, Fountain NB, Worrell GA, Gross RE, Eisenschenk S, Duckrow RB, Hirsch LJ, Bazil C, O'Donovan CA, Sun FT, Courtney TA, Seale CG, Morrell MJ. Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial. Epilepsia. 2014 Mar;55(3):432-41. doi: 10.1111/epi.12534. Epub 2014 Feb 22.
Morrell MJ; RNS System in Epilepsy Study Group. Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology. 2011 Sep 27;77(13):1295-304. doi: 10.1212/WNL.0b013e3182302056. Epub 2011 Sep 14.
Other Identifiers
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PMA100026
Identifier Type: OTHER
Identifier Source: secondary_id
NP10012
Identifier Type: -
Identifier Source: org_study_id
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