First Surgery on the East Coast; Second to be Performed in the U.S.
NEW YORK, NY (June 9, 2004) – A surgeon-scientist at NewYork-Presbyterian Hospital/Columbia University Medical Center has successfully implanted the Responsive Neurostimulator System (RNSÔ) electrical stimulation device in a 27-year-old woman with epilepsy. The March 25th surgery, which is part of an ongoing multi-center clinical trial, was the first of its kind on the East Coast and only the second in the United States. The neurostimulator is designed to suppress seizures in patients with epilepsy before any symptoms appear, much like implantable cardiac pacemakers are intended to detect heart arrhythmias and then deliver an electrical stimulus to terminate them.
About the size of a pocket watch, the responsive neurostimulator (RNS) is surgically implanted in the patient’s skull and connected to electrode wires. These wires are either implanted within the patient’s brain or placed on the brain surface, in the area of the presumed seizure origin (or “focus”). The RNS continuously monitors the patient’s brain waves (EEG), and after identifying the “signature” of a seizure’s onset, the device delivers a brief and mild electric current to the brain to suppress seizures. Prior to surgery, the precise localization of the seizure onset involves detailed study of the patient’s recorded seizures, often with intracranial electrodes.
“The implantable neurostimulator offers patients who have not responded to other treatments new hope for a life without seizures,” said Dr. Robert Goodman, the study’s principal investigator and associate professor of clinical neurological surgery at Columbia University College of Physicians & Surgeons. “Previous testing of this approach was conducted on a short-term basis in patients where electrodes were implanted temporarily, as part of a standard epilepsy surgery evaluation. This study showed that localized electrical stimulation of the brain was safe and could suppress seizure activity.” NewYork-Presbyterian/Columbia participated in this separate multi-center study.
During the three-hour surgery, the surgeon makes a small opening in the skull, placing the neurostimulator in a tray-like holder fastened to bone. After surgery, patients do not feel the device in their head. Recovery in the hospital is usually three days.
Following surgery, patients will visit their neurologist, who will use a computer to program the neurostimulator to recognize the patient’s seizure activity. Patients will visit their neurologist every week for the first four weeks, and then monthly.
Other NewYork-Presbyterian/Columbia physicians involved with the study include Drs. Guy McKhann, Ronald Emerson, Lawrence Hirsch, Hyunmi Choi, Steven Karceski, and Anil Mendiratta.
In addition to NewYork-Presbyterian/Columbia, nine other medical centers are currently involved in the two-year study, including NewYork-Presbyterian/Weill Cornell.
# # #
Epilepsy is a neurological disease that affects 2.5 million Americans, or roughly one full percent of the population. The condition is characterized by abnormal electrical activity in the brain, resulting in reoccurring seizures. For many of those with epilepsy, the unpredictably of seizures may affect patients’ ability to drive and can disrupt school days, work responsibilities and social activities. A treatment that could successfully stabilize brain activity would allow those affected to experience, for the first time, a life without restrictions.