Neurodevices are finding application in many neurological disorders, offering hope in situations where conventional non-surgical treatments are ineffective or unavailable. Surgical procedures often involve intraoperative determination of optimal electrode placement, a lengthy undertaking often requiring trial- and-error evaluation of potential sites with a conscious, cooperative patient. Recent interest in the application of functional imaging, including functional magnetic resonance imaging (fMRI), to this problem has produced promising results. We will develop, design and evaluate a neurodevice pre- surgical planning and follow-up system utilizing functional imaging intended to assist in cortical electrode placement. The input to our system will be multiple images from computed tomography (CT) and magnetic resonance imaging (MRI) systems, particularly functional magnetic resonance imaging (fMRI) studies. The final product will be a modular extension to our FDA-cleared Prism View} software package, compatible with MRI systems currently used for brain imaging. We will demonstrate feasibility in Phase I by developing means for visualizing functional, physiologic and anatomical data in a fashion particularly suitable to planning cortical electrode placement and visualizing post-surgical results. We will be, and evaluating our system in a study of a small number of subjects. In Phase II, we will further refine our software tools, possibly expanding their application for other neurodevices; investigate additional features such as field modeling of stimulators; and evaluate our system in a larger cohort of subjects to more rigorously evaluate accuracy and precision in predicting optimal electrode placement. Greater confidence will be achieved in utilizing pre-surgical functional imaging to reduce the need for intraoperative electrophysiological testing, and this should translate to reduced operative times. Our initial focus is on applications involving fMRI and epidural cortical electrodes. However, it is expected that the technology will also be applicable to functional imaging by transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG); implantation of deep brain stimulation (DBS) devices; and ultimately modeling of stimulator field effects to support virtual neurodevice evaluation. We will develop, design and evaluate a pre-surgical planning and post-surgical follow-up system for neurodevice applications utilizing functional imaging. Our initial target application applies functional magnetic resonance imaging to cortical electrode placement. If successful, potential health benefits of this system include reduced operative time for neurodevice installation, increasing patient comfort and reducing risk; improved device functionality due to better electrode placement. Cost benefits are associated with reduced operative time. ? ? ?
