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Physician-scientists at NewYork-Presbyterian Hospital/Columbia and Weill Cornell are taking part in two important clinical trials designed to treat the epileptic seizures that curtail life for one in every 100 Americans. The trials are known as the "RNS Trial" and the "Intercept Trial," and although their goal is identical, how each gets there is quite different.

RNS is a reactive approach:

• Single piece device; implanted into a patient's skull
• Device anticipates a seizure and generates a counter shock to stop it
• For patients with a clearly defined seizure source

Intercept (DBS) is a proactive approach:

• Two piece device; implant in brain connected by wires to pack in patient's chest
• Consistent electronic signal stabilizes brain activity
• For patients whose seizures originate in several areas of the brain, or a patient whose seizure source cannot be clearly identified

The RNS Trial and the Intercept Trial are taking place at NewYork-Presbyterian/Columbia under the direction of Dr. Robert Goodman, and at NewYork-Presbyterian/Weill Cornell under the direction of Dr. Douglas Labar.

RNS Device Implanted in Epilepsy Patient at NewYork-Presbyterian/Columbia

First Surgery on the East Coast; Second to be Performed in the U.S.

A surgeon-scientist at NewYork-Presbyterian Hospital/Columbia University Medical Center has successfully implanted the Responsive Neurostimulator System (RNS™) 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.

Intercept (DBS) Device Implanted in Epilepsy Patient at NewYork-Presbyterian/Weill Cornell

First Surgery on the East Coast; Second to be Performed in the U.S.

A surgeon-scientist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center implanted a device that will allow deep brain stimulation (DBS) to be conducted on a patient with epilepsy. For the second time in the United States, an electronic pacemaker was implanted into the brain of a patient afflicted with the disease.

The device, known as the Intercept Epilepsy Control System, is part of the first ever clinical trial where DBS is being used to treat epilepsy. Physicians theorize that this ability to directly stimulate the brain might be the initial step towards a cure for the disease.

Medication is the standard treatment for epilepsy, points out Dr. Douglas Labar, who is the principal investigator of the trial at NewYork-Presbyterian/Weill Cornell, however, in one-third of patients, medicine alone is not effective in stopping seizures and, therefore, other treatment options need to be explored. Dr. Labar is also director of the Comprehensive Epilepsy Center at NewYork-Presbyterian/Weill Cornell and a professor of neurology and neuroscience at Weill Cornell Medical College.

The four-hour procedure, in which two electrodes were implanted into the patient's brain and a battery pack into his chest, was performed on April 15 by Dr. Michael G. Kaplitt, who is director of Stereotactic and Functional Neurosurgery at NewYork-Presbyterian/Weill Cornell and an assistant professor of neurological surgery at Weill Cornell Medical College.

The patient was asleep during the procedure and his head was fitted in a stereotactic frame to prevent movement. After a CT scan pinpointed the target area, the surgical team drilled two small holes, about the size of quarters, in his skull. Through these openings, the two electrodes were implanted into the anterior nucleus of the thalamus, a region of the brain, slightly behind the hairline, which is believed to regulate his epileptic seizures.

The electrodes were then each connected to a lead that runs under the scalp, down the back of the patient's neck, and over the clavicle to a pack that Dr. Kaplitt, towards the end of the surgery, implanted in the patient's chest. The pack, measuring about the size of a deck of cards, supplies electrical impulses to the brain.

During the following months, Dr. Labar will monitor the patient's progress and adjust the pack's output to peak its effectiveness in diminishing the frequency and severity of seizures. We need to look at how DBS affects the rate of seizures, the intervals between them, and how it interacts with medication the patient is taking, says Dr. Labar. All of these factor into how the pack will be programmed.

With the device, the electrodes and leads are permanent; the pack's battery has a life-span of roughly five years, and is designed to be replaceable.

Under the direction of Dr. Labar, NewYork-Presbyterian/Weill Cornell was also involved in testing of the Vagus Nerve Stimulator, an earlier implant for epilepsy, which works by stimulating a peripheral nerve in the neck. Like the Intercept, the Vagus Nerve Stimulator emits a consistent signal designed to keep brain activity stable. However, the Intercept system delivers a stimulus directly into the brain, whereas the Vagus Nerve Stimulator targets a peripheral nerve (with the idea that the nerve will transport stimulus to the brain).

In addition to NewYork-Presbyterian/Weill Cornell, 11 other medical centers are currently involved in the Intercept Trial, including NewYork-Presbyterian/Columbia.