Healthcare Industry News: Northstar Neuroscience
News Release - September 28, 2006
Northstar Neuroscience Announces Promising Data on the Use of Cortical Stimulation to Treat Stroke-Related Broca's Aphasia
In Feasibility Study, Cortical Stimulation Coupled With Intensive Speech-Language Therapy Appears Safe and May Enhance Language RehabilitationSEATTLE--(HSMN NewsFeed)--Northstar Neuroscience, Inc. (NASDAQ: NSTR ), a developer of medical devices for the treatment of neurological diseases and disorders, today announced promising initial data from an eight patient feasibility study (CHESTNUT) of cortical stimulation to treat stroke-related Broca's aphasia. The study's principal investigators found that investigational cortical stimulation in combination with intensive speech-language therapy may result in greater language improvement for chronic Broca's aphasia than speech-language therapy alone. These findings are being presented today at the American Congress of Rehabilitation Medicine / American Society of Neurorehabilitation Joint Educational Conference in Boston.
"The results, which showed clear speech improvements in the investigational group receiving cortical stimulation therapy, are promising for stroke survivors affected by aphasia," said Alan Levy, Ph.D., President and Chief Executive Officer of Northstar Neuroscience. "Many patients with aphasia are frustrated by their speech difficulties and believe there is no room for improvement. Cortical stimulation may offer additional hope for recovery, and we look forward to future research to confirm these initial findings."
The CHESTNUT study, with principal investigators Steven L. Small, M.D., Ph.D. of the University of Chicago's Department of Neurology and Leora R. Cherney, Ph.D. of the Rehabilitation Institute of Chicago's Center for Aphasia Research, completed patient enrollment in June. The study was comprised of randomly assigned investigational and control patients matched by severity of aphasia. Over a six week period, all participants received intensive speech and language therapy. The investigational group also received cortical stimulation during the speech and language therapy sessions. Cortical stimulation therapy involves the precise delivery of low levels of electricity to the outer layer of the brain via an implanted stimulator system.
Speech and language recovery was measured using the Western Aphasia Battery-Aphasia Quotient (WAB-AQ). A 5-point improvement from baseline is considered a successful outcome. For all CHESTNUT participants, WAB-AQ assessments were performed at various points during the study to assess changes. The investigational group showed a mean WAB-AQ improvement from baseline of 8.0 points both immediately post-therapy and at the 6-week follow-up compared to 4.6 points and 5.5 points for the control group, respectively. Follow-up data at 12 weeks is available for 6 of the 8 patients and indicates that a greater increase occurred in the investigational group, with a mean change of 12.4 points versus a 4.1 points change in the control group.
"The preliminary results are particularly noteworthy because all study participants were more than a year since stroke onset," stated Dr. Cherney. "The potential for affecting cortical plasticity in patients with chronic aphasia to enhance speech-language therapy outcomes is exciting for the field of speech and language pathology and for stroke rehabilitation in general." Added Dr. Small, "Although data from a small group of patients must be taken with some caution, the present results are certainly provocative. The differences in primary outcome were accompanied by somewhat different patterns of brain imaging data, particularly involving the premotor areas. Taken together, these data suggest an altered neurobiological response to speech-language therapy in the presence of cortical stimulation."
About Northstar Neuroscience
Northstar Neuroscience, Inc. is a medical device company focused on developing and commercializing innovative neurostimulation therapies to restore function and quality of life for people suffering from stroke and other neurological diseases and disorders. Northstar's cortical stimulation therapy system is an investigational device that is in clinical trials for several indications, including stroke motor recovery, aphasia, tinnitus and depression. 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 ability to complete our ongoing or any future clinical trials including those related to aphasia, delays in conducting or completing any of our clinical trials, the results of any of our clinical trials, including the final results of the CHESTNUT clinical trial, and results from our feasibility trials may not be indicative of our success in any later clinical trials involving a larger number of patients. 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 August 11, 2006 and in other documents and reports we file periodically with the Securities and Exchange Commission.
Source: Northstar Neuroscience
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