Northstar Neuroscience Announces Initial Feasibility Data on the Use of its Renova(TM) Cortical Stimulation System to Treat Tinnitus.
SEATTLE -- Northstar Neuroscience, Inc. (NASDAQ NASDAQ
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NSTR Naval Sea System Command Technical Representative ), a developer of medical devices for the treatment of neurological diseases and disorders, today announced promising initial data from an eight patient investigational device feasibility study (SAHALE) of cortical stimulation to treat tinnitus Tinnitus Definition
Tinnitus is hearing ringing, buzzing, or other sounds without an external cause. Patients may experience tinnitus in one or both ears or in the head. . The study's principal investigators, Brian Kopell, M.D. of the Medical College of Wisconsin's Department of Neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system.
Surgery on any part of the nervous system. and David Friedland, M.D., Ph.D. of the Medical College of Wisconsin's Department of Otolaryngology, found that investigational cortical stimulation of the auditory cortex auditory cortex
The region of the cerebral cortex that receives auditory data from the medial geniculate body. Also called auditory area. for the suppression of tinnitus is feasible and appears to be safe. These findings were presented by Dr. Friedland this past weekend at the annual meeting of the American Neurotology Society in San Diego.
"In this initial feasibility study, we have established that cortical stimulation appears to be safe and affect tinnitus symptoms on a long-term basis," says Dr. Kopell. "Ongoing investigation may allow us to further improve patient selection and efficacy of the therapy."
"The results are promising and show improvements in alleviating tinnitus symptoms," said Alan Levy, Ph.D., President and Chief Executive Officer of Northstar Neuroscience. "Many patients with tinnitus have become frustrated by the lack of treatment options and are often told there is nothing that can be done. Cortical stimulation may offer additional hope for those suffering from severe tinnitus and we look forward to future research to expand these findings."
The SAHALE study completed patient enrollment in November 2006. Eight patients with severe tinnitus were included in the study; the average duration of tinnitus symptoms was 16 years and average severity rating was 79 on a scale of zero to 100. All patients were implanted with Northstar's investigational Renova-TT[TM] Cortical Stimulation System designed to deliver low levels of electric stimulation to the outer layer of the brain just over the auditory cortex. Patients initially received active or sham stimulation (crossover design) and were regularly asked to rate the loudness and severity of their tinnitus symptoms as well as the perceived effectiveness of the cortical stimulation therapy; after the crossover phase, all patients received active stimulation. Patients' quality of life was also assessed periodically using the Tinnitus Reaction Questionnaire (TRQ TRQ Torque
TRQ Testing Requirements
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TRQ Tariff Rated Quota
TRQ Tear-Down Request Queue ), Tinnitus Handicap Questionnaire (THQ THQ Toy Headquarters
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THQ The Holy Quran
THQ Theater Headquarters ) and the Beck Depression Inventory Beck Depression Inventory
A trademark for a standardized questionnaire used to diagnose depression.
Beck Depression Inventory (BDI BDI Burundi (ISO Country code)
BDI Beck Depression Inventory
BDI Belief-Desire-Intention (AI agents)
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All patients showed improvement in the TRQ and THQ quality of life measures by the end of 12 weeks, and all but one patient showed improvement in the BDI measure. Two patients had sustained reduction of pure tone tinnitus and six patients had short periods of total tinnitus suppression. Two of the patients in the study suffered from moderate to severe depression; both improved to mild or minimal depression following cortical stimulation. No surgical complications or significant changes in hearing threshold were observed.
"These preliminary results are encouraging, as patients showed notable improvements on the Tinnitus Reaction Questionnaire, the Tinnitus Handicap Questionnaire, and the Beck Depression Inventory during cortical stimulation," stated Dr. Friedland. "Most subjects experienced episodes of total tinnitus suppression at some point during the study despite having had constant tinnitus for years." Added Dr. Kopell, "Further studies will investigate different stimulation regimen, identification of characteristics to predict a positive outcome, and better understanding of the long-term effects of stimulation on tinnitus symptoms."
About Northstar Neuroscience
Northstar Neuroscience is a medical device company focused on developing neurostimulation therapies that offer greater hope for recovery from neurological injury, disorder and disease. Northstar's proprietary Renova[TM] Cortical Stimulation System is an investigational device that delivers targeted electrical stimulation to the outer surface of the brain - the cerebral cortex cerebral cortex
Layer of gray matter that constitutes the outer layer of the cerebrum and is responsible for integrating sensory impulses and for higher intellectual functions. . The Renova system is currently under investigation for several indications, including stroke motor recovery, aphasia aphasia (əfā`zhə), language disturbance caused by a lesion of the brain, making an individual partially or totally impaired in his ability to speak, write, or comprehend the meaning of spoken or written words. , 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 Safe Harbor
1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.
2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 tinnitus, delays in conducting or completing any of our clinical trials, the results of any of our clinical trials, including the results of the SAHALE clinical trial, our ability to obtain regulatory approval for, or to commercialize, any of our investigational devices, 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 Annual Report on Form 10-K Form 10-K
A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.
See 10-K. filed with the Securities and Exchange Commission and in other documents and reports we file periodically with the Securities and Exchange Commission.
Investigational device. Limited by Federal (or United States) law to investigational use.