70
Participants
Start Date
January 31, 2004
Primary Completion Date
May 31, 2006
Study Completion Date
December 31, 2007
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.
Weill Medical College of Cornell University, New York
Columbia University / Columbia Presbyterian Medical Center, New York
Johns Hopkins University School of Medicine, Baltimore
Medical College of Georgia, Augusta
Mayo Clinic Jacksonville, Jacksonville
Henry Ford Hospital, Detroit
Mayo Clinic Rochester, Rochester
Rush University Medical Center / Epilepsy Center, Chicago
Louisiana State University Epilepsy Center of Excellence, New Orleans
Mayo Clinic Scottsdale, Phoenix
Swedish Medical Center, Seattle
Yale University School of Medicine, New Haven
Lead Sponsor
NeuroPace
INDUSTRY