This proposal is to conduct a pilot clinical study of an innovative device: a portable, pseudo random modulation (PRM) and laser based sensor for non-invasive detection and monitoring of hematomas in patients with traumatic brain injuries. This low cost and robust device is easy to operate and maintain. The sensor can rapidly and accurately diagnose the presence of extravasated intracranial blood on an emergent basis outside and within the hospital. Its utility in emergency sites will significantly improve the initial care and management of head injury patients. The proposed program is built on our prior experience with PRM technology for blood oxygenation measurement and positive results of preliminary clinical tests. After defining the biochemical and optical performance characteristics needed for clinical applications, we will design and develop an instrument whose performance is optimized for hematoma detection. It will use specific clinical protocols and algorithms for brain hematoma detentions/monitoring along with clinical test to meet clinical diagnostic accuracy requirement. The objective of the proposal is to develop and optimize a unique PRM device and to test the accuracy and utility of this prototype sensor for clinical application of non-invasive brain hematoma detection and monitoring at emergency site, hospital ER and ICU.
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