SEATTLE, March 1, 2006 – Physicians with the Seattle Neuroscience Institute (SNI) at Swedish Medical Center are now enrolling participants in the Responsive Neurostimulator (RNSTM) System Pivotal Clinical Investigation, a multi-center clinical trial of a responsive brain neurostimulator for the treatment of epilepsy. The RNS is an implantable device designed to suppress seizures in people with epilepsy before any symptoms appear – much like implantable cardiac pacemakers are intended to detect abnormal heart rhythms before delivering electrical stimulation to correct them.
The RNS is surgically implanted under the scalp and connected to one or two leads (insulated wires with four small electrodes at the end). These leads are implanted within the patient’s brain and/or placed on the brain surface, in the area of the presumed seizure origin. The RNS continuously monitors the patient’s brain waves. When seizure activity is detected, the device delivers brief and mild electrical stimulation through the leads in an attempt to suppress seizures.
After the RNS is implanted, patients visit their neurologist for follow-up appointments. The neurologist uses a modified laptop computer to program the device to recognize the patient’s seizure activity. When seizure activity is detected, the RNS delivers stimulation that is intended to stop the seizure from occurring.
Previous clinical testing of responsive stimulation to control epilepsy was conducted in 65 patients implanted with the device in the RNS System Feasibility Clinical Investigation. This study, which SNI physicians took part in, was designed to evaluate safety and obtain initial evidence of efficacy of the RNS system in treating epilepsy. As a result of this study, the FDA has granted approval to conduct the RNS System Pivotal Clinical Investigation.
People who are eligible to take part in the RNS System Pivotal Clinical Investigation are adults (18 to 70 years of age) who have an average of three or more partial (focal) onset seizures that have not been controlled on at least two antiseizure medications. Before enrolling in the trial, potential participants must have various standard tests done – that may include EEG (electroencephalography) and MRI (magnetic resonance imaging) – to localize their seizure onset area(s).
Once enrolled, participants undergo a baseline evaluation for a minimum of three months. During this period, participants keep a seizure diary and see a neurologist on a regular schedule. Participants who meet the seizure frequency criteria of an average of three or more seizures per month for three consecutive months are eligible to receive the implanted neurostimulator. After the device is implanted, participants are followed for two years. Seizure type and frequency, as well as physical and emotional health are then assessed on a regular basis.
Epilepsy is a common neurological condition affecting about 2.5 million Americans of all ages. As many as 50 percent of people with epilepsy continue to have seizures or have antiseizure medication-related side effects despite the best medical efforts to control their seizures. Some people are candidates for epilepsy surgery to remove the seizure focus. However, people with certain types of epilepsy are unlikely to respond to surgery or may be at high risk for surgery-related neurological complications. Brain devices to treat epilepsy may offer hope to people with epilepsy who are not adequately treated by antiseizure medication and are not candidates for safe and effective surgery.
SNI physicians David Vossler. M.D., and Ryder Gwinn, M.D., are the co-principal investigators of this clinical trial at Swedish Medical Center. Swedish is one of only 28 medical centers in the United States taking part in the trial and the only site in Washington state, Alaska, Montana and Idaho.
For more information about the RNS System Pivotal Clinical Investigation, call 206-386-3880 or visit www.neuropace.com.
In 2004, Swedish Medical Center expanded its neuroscience services by establishing the Seattle Neuroscience Institute at Swedish Medical Center. The team of leading neurosurgeons and other specialists are building a world-class institute dedicated solely to the treatment and advancement of neurological disorders for patients in the Pacific Northwest and around the world. Formerly known as the Swedish Neuroscience Institute, the name was changed to reflect the program’s broader scope and reach. The Swedish Medical Center/Providence Campus has been designated as the hub for the Institute and is being upgraded with four state-of-the-art operating rooms some with neuro-interventional radiology capabilities, and a renovated neuro intensive-care unit. Although the Institute is based at Swedish/Providence, neuroscience research and treatment continues to be a multi-campus program. SNI specializes in the research for and treatment of stroke, movement disorders such as Parkinson’s disease, tremors and Tourette’s syndrome; epilepsy; child neurological disorders; neuro-ophthalmology; headaches; multiple sclerosis and many other neurological conditions and diseases.
Swedish is the largest, most comprehensive, nonprofit health provider in the Pacific Northwest. It is comprised of three hospital campuses (First Hill, Providence and Ballard), a new community-based emergency room and specialty center in Issaquah, Swedish Home Care Services and Swedish Physicians – a network of 12 primary-care clinics. In addition to general medical and surgical care, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiac care, oncology, orthopedics, high-risk obstetrics, neurological care, sleep medicine, pediatrics, organ transplantation and clinical research. For more information, visit www.swedish.org
Media Note: As qualified candidates are enrolled in this clinical
trial at Swedish, Drs. Vossler and Gwinn will attempt to identify enrollees
who would be willing to speak with interested media. To inquire about this possibility,
simply contact Ed Boyle in Swedish’s Corporate Communications Department.