Cell-based Model for Electrical Stimulation Safety Studies

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DESCRIPTION (provided by applicant): Cell-based Model for Electrical Stimulation Safety Studies The development of an in vitro, cell-based model to evaluate the effects of electrical stimulation on central nervous system (CNS) cells is proposed. The model would be used to establish likely injurious and non-injurious levels of stimulation in prostheses and therapies that employ electrodes chronically implanted in the CNS. The model would minimize the number of animals needed to assess the safety of stimulation protocols, allow the investigation of a wider range of stimulation parameters than is practical or cost-effective solely with animal studies, and would provide a controlled environment for studying mechanisms of cell damage induced by electrical stimulation. The Phase I effort has three Aims: 1) to develop a three-dimensional cell culture model suitable for stimulation studies with penetrating and planar microelectrodes, 2) to develop techniques to measure the influence of electrical stimulation on cell function, pro-inflammatory response, and cell viability, and 3) to correlate cellular responses in the model to stimulation protocols known to be safe or injurious based on intracortical electrode studies in animals. In Phase II, the model would be validated by side-by-side comparisons of model results and animal studies, and potential mechanisms of stimulation-induced neural tissue damage investigated. The program is collaborative effort between EIC Laboratories, Brown University, and the Huntingdon Medical Research Institutes (HMRI). The initial commercialization objective for is to provide testing services to medical device companies and the sale of test systems to contract research organizations and research institutions.