SBIR-STTR Award

Stochastic resonance (SR) is a counterintuitive phenomenon in which slight amounts of noise imparted to a system actually increase its sensitivity to weak stimuli. SR has been shown to produce a demonstrable effect in human sensory cells. In both healthy young and clinical subjects - elderly, diabetics, and stroke sufferers - a notable increase in tactile and proprioceptive sensitivity is seen when electrical or mechanical noise is presented at the site of the stimulus. Dysfunction in these sensory systems is known to have significant clinical sequellae including gait abnormalities, propensity to fall, and foot ulcers. Together, these conditions cost the U.S. healthcare system many billions of dollars annually. The proposed research will initiate a development program whose ultimate goal is to produce fully implantable medical devices that capitalize on this effect to treat certain types of sensory dysfunction. In an acute in-vivo animal model, we will test the hypothesis that sub- sensory noise delivered via subcutaneous electrodes placed near mechanoreceptors in the lower leg improves the ability of those receptors to discern slight rotations about the ankle. Direct recordings will be made of afferent nerve signals from those mechanoreceptors. We will also assess whether the receptors adapt to the noise stimulation, rendering it ineffective over time. PROPOSED COMMERCIAL APPLICATIONS: If successful, the proposed research can lead to implantable medical devices that improve somatosensory sensitivity in people who suffer from peripheral neuropathy. This would improve quality of life for these individuals while reducing the costs of caring for them. Applications include uses in improving gait and balance, some forms of incontinence, and rehabilitation medicine.

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.

Thesaurus Terms:
biomedical equipment development, clinical biomedical equipment, electronic stimulator, implant, rehabilitation, sensorimotor system, stroke therapy afferent nerve, biological model, body movement, electrode, electrostimulus, human therapy evaluation, muscle function, neural plasticity, nonhuman therapy evaluation, portable biomedical equipment, proprioception /kinesthesia, therapy design /development bioengineering /biomedical engineering, clinical research, human subject, laboratory rat, medical implant science, medical rehabilitation related tag, patient oriented research