Near-infrared Optical Biosensor Brain Injury Evaluation

Near-infrared light (NIR) can detect intracranial hematomas with good sensitivity and specificity. However, commercial systems have not proved clinically useful. Early detection of hematomas is important for emergency head injury evaluation. The resulting pressure can cause significant brain damage or death, yet the pressure can be relieved if detected. We propose to create a portable NIR system that is accurate without MRI or CT imaging. It will provide detection before symptoms of intracranial pressure are severe. It will be quick, easy to use and reliable with minimal training. It will be inexpensive enough to find widespread civilian and military use. We begin with a design for an optimal device for rapid, effective diagnosis in the civilian emergency department and the military field or ship hospital. We identify the technical problems that must be solved in order to achieve this optimal device and procedure. We then demonstrate the feasibility of solving the key problems, drawing on several proprietary advances based on our DARPA NIR project. Finally, based on our experience with dense array EEG in emergency medicine, we design a clinical trial for Phase II that will validate both statistical and clinical significance of the Near-infrared Optical Biosensor Brain Injury Evaluation (NOBBIE) technology.