RNS® System Epilepsy PAS



Status:Enrolling by invitation
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:April 2015
End Date:May 2023

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RNS® System Post-Approval Study in Epilepsy

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.

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.

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
We found this trial at
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Chapel Hill, North Carolina 27599
(919) 962-2211
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Los Angeles, California 90033
213) 740-2311
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
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1500 Red River Street
Austin, Texas 78701
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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1801 Inwood Rd
Dallas, Texas 75390
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Grand Rapids, Michigan 49503
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Irvine, California 92697
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Lebanon, New Hampshire 03756
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Lexington, Kentucky
859) 257-9000
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Memphis, Tennessee 38103
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
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New Haven, Connecticut 6520
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New York, New York 10016
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Palo Alto, California 94304
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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1020 Walnut St
Philadelphia, Pennsylvania 19107
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