Northstar Neuroscience Announces Initial Feasibility Data on the Use of its Renova(TM) Cortical Stimulation System to Treat Tinnitus.
"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), Tinnitus Handicap Questionnaire (THQ) and the Beck Depression Inventory (BDI).
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. The Renova system is currently under investigation 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 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 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.
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|Date:||Apr 30, 2007|
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