100
Participants
Start Date
August 9, 2022
Primary Completion Date
April 4, 2025
Study Completion Date
March 31, 2026
Responsive stimulation
The RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs.
Sham stimulation
For those in the Sham Stimulation group, the RNS System will be set to detect abnormal activity but will not have responsive stimulation enabled. Both Sham and Active groups will undergo therapy testing at each appointment in order to maintain the blind.
New York University Langone, New York
UPMC, Pittsburgh
University of Pennsylvania, Philadelphia
Thomas Jefferson University, Philadelphia
Nicklaus Children's Hospital, Miami
University of South Florida, Tampa
University of Alabama at Birmingham, Birmingham
Vanderbilt University Medical Center, Nashville
University of Louisville, Louisville
Indiana University Health, Indianapolis
Spectrum Health Butterworth Hospital, Grand Rapids
Mayo Clinic - Rochester, Rochester
Washington University, St Louis
University of Kansas Medical Center, Kansas City
Baylor College of Medicine, Houston
The University of Texas Health Science Center at Houston, Houston
University of Colorado, Aurora
University of Utah Healthcare, Salt Lake City
Mayo Clinic - Arizona, Phoenix
University of New Mexico, Albuquerque
Oregon Health and Science University, Portland
Massachusetts General Hospital, Boston
Mary Hitchcock Memorial Hospital (Dartmouth), Lebanon
Lead Sponsor
NeuroPace
INDUSTRY