Healthcare Industry News: neurostimulation
News Release - June 26, 2006
Northstar Neuroscience Announces Completion of Enrollment in Feasibility Study of Cortical Stimulation to Treat Stroke-Related Broca's AphasiaSEATTLE--(HSMN NewsFeed)--June 26, 2006--Northstar Neuroscience, Inc. (NASDAQ: NSTR ), a developer of medical devices for the treatment of neurological diseases and disorders, today announced the completion of patient enrollment and randomization in its feasibility study of cortical stimulation to treat stroke-related Broca's aphasia (or non-fluent aphasia). Called CHESTNUT, the study was designed to assess the safety and effectiveness of an investigational cortical stimulation system when used during speech-language rehabilitation. Approximately one million individuals in the United States suffer from aphasia, an impairment in speech or language. Currently, there are no proven treatments for aphasia beyond rehabilitation.
Cortical stimulation therapy refers to the precise delivery of low levels of electricity to the outer layer of the brain via an implanted stimulator system. Cortical stimulation involves a procedure to place a small electrode (about the size of a postage stamp) over the tough membrane that protects the cortex of the brain (the dura). The electrode is then connected via a lead wire to a pulse generator implanted under the skin just below the collarbone. The pacemaker-sized generator and lead wire are implanted under the skin.
In the CHESTNUT study, participants were randomly assigned to either the investigational group or the control group. Patients in the investigational group were implanted with the cortical lead and generator, and received cortical stimulation during intensive speech-language therapy. The control group patients received intensive speech-language therapy only. The study's Principal Investigators, Steven L. Small, M.D., Ph.D. of the University of Chicago's department of Neurology and Leora Cherney, Ph.D. of the Rehabilitation Institute of Chicago's Center for Aphasia Research, will present the results of this eight patient feasibility study at the American Congress of Rehabilitative Medicine / American Society of Neurorehabilitation Joint Educational Conference to be held in Boston from September 27-30, 2006.
"For stroke survivors, aphasia is profoundly debilitating," said Alan Levy, Ph.D., President and Chief Executive Officer of Northstar Neuroscience. "The inability to successfully communicate presents challenges and complications that significantly impact an individual's personal and professional life. The CHESTNUT study is the first of its kind to investigate the use of an implantable cortical stimulation system with stroke-related aphasia patients. We are pleased to have completed enrollment on schedule and we look forward to seeing the results of this important study."
According to the National Aphasia Association, approximately one million people in the U.S. have aphasia and the majority of cases are the result of stroke. Patients with aphasia experience a language impairment that affects production or comprehension of speech. Aphasia can also affect the ability to read or write. Speech and language problems vary and significant improvements from speech therapy are uncommon after one year post-stroke.
Stroke is a leading cause of serious, long-term disability in the U.S. According to the American Stroke Association, over five million people in the U.S. are survivors of stroke, with approximately 700,000 additional strokes occurring annually. Each year over 200,000 people in the U.S. become significantly and permanently disabled due to stroke. The direct and indirect cost of stroke in 2006 is estimated to be over $55 billion.
About Northstar Neuroscience
Northstar Neuroscience, Inc. is a medical device company focused on developing and commercializing neurostimulation therapies that restore function and quality of life for people who suffer from neurological diseases and disorders. Northstar is currently enrolling patients in the EVEREST pivotal clinical trial of cortical stimulation for hand/arm recovery following stroke, as well as a feasibility trial of cortical stimulation to treat tinnitus (the debilitating perception of intense sound or "ringing in the ears"). For more information, visit www.northstarneuro.com.
This release contains information about management's view of our future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with our financial condition, our ability to complete our ongoing or any future clinical trials, delays in conducting or completing any of our clinical trials, and the results of any of our clinical trials, including the results of the CHESTNUT clinical trial. We encourage you to review other factors that may affect our future results in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on June 6, 2006 and in other documents we file periodically with the Securities and Exchange Commission.
Source: Northstar Neuroscience
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