240
Participants
Start Date
December 31, 2005
Primary Completion Date
October 31, 2009
Study Completion Date
May 31, 2011
RNS® System implantation
Using standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.
RNS® System responsive stimulation
The RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.
Columbia University / Columbia Presbyterian Medical Center, New York
University of Rochester, Rochester
Thomas Jefferson University, Philadelphia
George Washington University, Washington D.C.
Johns Hopkins University School of Medicine, Baltimore
University of Virginia, Charlottesville
Wake Forest University Health Sciences, Winston-Salem
Medical University of South Carolina, Charleston
Emory University, Atlanta
Medical College of Georgia / Georgia Health Sciences University, Augusta
Mayo Clinic - Jacksonville, Jacksonville
University of Florida at Gainesville, Gainesville
Miami Children's Hospital, Miami
University of Alabama at Birmingham, Birmingham
Cleveland Clinic Foundation, Cleveland
Indiana University, Indianapolis
Henry Ford Hospital, Detroit
University of Wisconsin Hospital and Clinics, Madison
Mayo Clinic - Rochester, Rochester
Rush University Medical Center/ Epilepsy Center, Chicago
Via Christi Comprehensive Epilepsy Center, Wichita
University of Texas Southwestern Medical Center, Dallas
Baylor College of Medicine, Houston
Mayo Clinic - Arizona, Phoenix
University of Southern California, Los Angeles
California Pacific Medical Center, San Francisco
Oregon Health & Science University, Portland
Swedish Medical Center, Seattle
Yale University School of Medicine, New Haven
Massachusetts General Hospital, Boston
Dartmouth-Hitchcock Medical Center, Lebanon
Saint Barnabas Medical Center, Livingston
Lead Sponsor
NeuroPace
INDUSTRY