Stroke survivors constitute one of the largest groups of patients receiving rehabilitation services in the United States. The inability of most stroke survivors to regain full sensorimotor function significantly impacts quality of life while generating tremendous ongoing health care costs and losses to productivity. Recent scientific and clinical findings have provided new foundations for development of advanced therapies and technologies that strive to restore brain function post stroke. Among these findings is that sensory neuron activity in the periphery is a strong driver of the central neuroplastic changes that are necessary to regain cortical function. The Company's technology has been shown to increase this type of sensory flow in a manner that improves sensorimotor performance. The broad aim of this SBIR Phase II program is to fabricate and test novel stroke neurotherapy devices whose operating principles leverage the power of sensory activity and the compelling findings of our Phase I research. The Phase I research showed that subcutaneous stochastic resonance (SR) noise-based stimulation boosts afferent activity in a manner that is concordant with natural neuronal firing patterns and consequently increases information content. Our Phase II effort will utilize animal models of stroke rehabilitation and chronic post-stroke human subjects to explore the efficacy of this technology. Specifically, this program will accomplish the following objectives: (1) develop the technology to support advanced animal and chronic post-stroke human studies, (2) use an established animal stroke and rehabilitation model to demonstrate the utility of SR-based stimulation in accelerating return to function, (3) use skin surface and in-dwelling electrodes to deliver SR stimulation in human stroke subjects to gauge acute improvements in motor performance, and (4) demonstrate in a pilothuman stroke group that SR stimulation can improve motor relearning outcomes. The results gained from this program are expected to motivate a full-fledged product development effort, pivotal clinical trials, regulatory filings, and market introduction.
