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

Use our guide to learn which trials are right for you!

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
28
sites
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
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...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
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...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1500 Red River Street
Austin, Texas 78701
?
mi
from
Austin, TX
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Memphis, Tennessee 38103
?
mi
from
Memphis, TN
Click here to add this to my saved trials
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Salt Lake City, Utah 84103
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Seattle, Washington 98104
?
mi
from
Seattle, WA
Click here to add this to my saved trials