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Brain Stimulation Study May Help Stroke Survivors

Study Aims To Improve Arm And Leg Movement

PITTSBURGH, February 14, 2006 — Physicians at the University of Pittsburgh Medical Center are participating in a multicenter study that may help stroke survivors gain greater use of their arms and hands by electrically stimulating the brain during physical rehabilitation. Previous pilot studies have shown that such a combination is safe and enhances motor function more than rehabilitation alone. The electrical stimulation is provided by the temporary surgical placement of an electrode on the covering of the brain.

“The most common neurological deficit among stroke survivors, and a substantial contributor to post-stroke disability, is motor weakness on one side of the body. Presently, the only treatment available for patients with such deficits is rehabilitative therapy. However, many patients are not responsive to standard therapy or they achieve a less than satisfactory improvement in function,” said Douglas Kondziolka, M.D ., Peter J. Jannetta Professor of Neurological Surgery and Radiation Oncology and Vice Chairman of Education, department of neurological surgery, at the University of Pittsburgh School of Medicine.

Following a stroke, many patients show some spontaneous neurologic improvement. Restoration of function may be the consequence of the brain’s neuroplasticity, which is a mechanism in which new areas of the brain take over the function of stroke-damaged areas. The brain’s cerebral cortex, with its extensive network of interconnected neurons, is thought to be an important site for neuroplasticity. This area of the brain will be stimulated during the study.

Participants in the study will have an electrode surgically placed on the membrane, called the dura, which covers the brain. A wire from the electrode will be tunneled under the skin to a stimulating device about the size of a pacemaker that will be placed under the skin near the collarbone. The stimulator will be turned on just before the start of the daily rehab session and will be turned off when the session is over. The electrode and stimulator will be removed about eight weeks after the completion of the rehab period. Participants will be followed closely for signs of improvement for six months and will be compared to a control group, which will undergo rehabilitation only. The rehab portion of the study will take place at the Institute for Rehabilitation and Research at UPMC South Side and will last for six weeks.

Stroke is a leading cause of serious, long-term disability in the United States. According to the American Stroke Association, approximately 4.8 million people are affected by stroke in the U.S., with approximately 700,000 additional strokes occurring annually. The 2001 overall death rate for stroke was 58 percent. Of those who survive, 30 to 50 percent do not regain functional independence, 15 to 30 percent are permanently disabled, and 20 percent require institutional care at three months after onset. Thus, approximately 150,000 stroke survivors become significantly and permanently disabled each year. In 1999, more than 1.1 million American adults reported difficulty with functional limitations and activities of daily living resulting from stroke. The 2004 cost of stroke is estimated to have been $53.6 billion.

Nationwide, the study will enroll 174 subjects. It will include participants age 21 years or older who have had an ischemic stroke at least four months prior to screening and suffered resulting weakness in one hand and/or arm. Participants will be randomized to either stimulation with rehabilitation or rehabilitation alone. This study is sponsored by Northstar Neuroscience of Seattle, which developed the technology.

For additional information on the study, please call 412-647-4994.

About the University of Pittsburgh Medical Center

The University of Pittsburgh Medical Center is the largest integrated health care delivery system in Pennsylvania and one of the leading nonprofit medical centers in the country. UPMC is a $5.8 billion, 40,000-employee organization and the largest employer in western Pennsylvania. UPMC is consistently ranked among the nation’s top hospitals by U.S. News & World Report and the University of Pittsburgh and affiliated programs attract more than $375 million annually in National Institutes of Health (NIH) funding, ranking the academic medical center seventh in the nation in 2004. For more information about UPMC visit the Web site at http://www.upmc.com/.

About Northstar Neuroscience

Northstar Neuroscience, Inc., headquartered in Seattle, is a medical device company focused on providing innovative neurostimulation therapies that restore function and quality of life for people suffering from stroke and other neurological diseases and disorders. Additional information about Northstar can be found at http://www.northstarneuro.com/.

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