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Stroke is a major cause of mortality and is the primary cause of long-term disability in the United States. A recent study of Stroke incidence, using conservative calculations, suggests that over 700,000 people annually in this country will have a stroke. Of these 700,000, approximately 150,000 will die and 400,000 will be left with a significant deficit; only one quarter will return to an independent--although not necessarily baseline--level of functioning. The costs of caring for victims of stroke in the acute phase, chronic care, and lost productivity amount to 40 billion per year. Of all strokes, approximately 20% are hemorrhagic and 20% are due to small vessel disease. Thus, the number of people with large vessel thromboembolic disease and the target population of this research is greater than 400,000. Currently, the only approved therapy for treatment of acute ischemic stroke is intravenous thrombolytic drugs. While stroke patients who receive these drugs are more likely to have better outcomes than those who do not, their improvement is highly dependent on the initiation of treatment within three hours of the onset of symptoms, with an increased risk of intracranial hemorrhage if the medication is begun outside this time window. With this rigid temporal limitation, and with the concern over intracranial hemorrhage, only 2-3% of people with acute stroke are currently being treated by these means. There is ongoing research for a second treatment methodology involving the use of mechanical devices for removing the thrombus (clot) in stroke victims. Two recent reports of a mechanical removal of thrombus, with subsequent improved patient outcome, highlight the potential of this developing technology. Researchers in the MTP are responsible for one of the photomechanical devices under FDA trials. It is conceivable that in the near-term, a second approved therapy for treatment of acute ischemic stroke will involve the mechanical removal of the thrombus. Stroke is a major thrust area for the Medical Technology Program (M-division). Through MTP, LLNL has a sizable investment and recognizable expertise in stroke treatment research. The proposed microdot array sensor for stroke will complement this existing program in which mechanical devices are being designed for removing the thrombus. The following list of stroke projects and their relative status shows that MTP has a proven track record of taking ideas to industry: The goal of this LDRD funded project was to develop and demonstrate a minimally invasive optical fiber-based sensor for rapid and in-vivo measurements of multiple stroke biomarkers (e.g. pH and enzyme). The development of this sensor also required the development of a new fabrication technology for attaching indicator chemistries to optical fibers. A benefit of this work is to provide clinicians with a tool to assess vascular integrity of the region beyond the thrombus to determine whether or not it is safe to proceed with the removal of the clot. Such an assessment could extend the use of thrombolytic drug treatment to acute stroke victims outside the current rigid temporal limitation of 3 hours. Furthermore, this sensor would also provide a tool for use with emerging treatments involving the use of mechanical devices for removing the thrombus. The sensor effectively assesses the risk for reperfusion injury

FY04 LDRD Final Report Stroke Sensor Development Using Microdot Sensor Arrays