SBIR Phase I: Development of Transcutaneous Electrical Spinal Cord Neuromodulator for Home Use

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to build a non-invasive device that can deliver sufficient electrical signals to activate the intrinsic circuits controlling bladder and sphincter function. This technology will reactivate the previously-dormant neural circuits. Current medical approaches focus on management of symptoms, rather than restoration of function. Indeed, they often completely obliterate one function of the bladder (sensation, storage or emptying) in order to facilitate the other. Noninvasive spinal neuromodulation offers a different approach, with a focus on functional restoration, not functional management. This project addresses a condition that impacts the quality of life of millions of Americans. Urinary incontinence, recurrent urinary tract infections and dependence on catheters for bladder emptying are some of the bladder problems experienced by people with paralysis. The company seeks to stimulate the spinal cord in a noninvasive manner called Transcutaneous Electrical Spinal Cord Neuromodulation. In preliminary studies, it was demonstrated that this therapy can reduce detrusor overactivity to increase bladder capacity and reduce episodes of incontinence, and facilitate retraining of the sensory component of bladder control to improve sensation of fullness. This project will focus on a reconfiguration of the device to make it compatible with home use. This reconfiguration includes designing a portable device for home use, testing and confirming electrical safety of the more compact design, and comparison of waveforms with prototype devices. This device has the potential to become a novel therapy for the treatment of Neurogenic Lower Urinary Tract Dysfunction (NLUTD). If successful, for the first time, this technology will give NLUTD patients a modality to improve their bladder symptoms without the side effects of medications or risks of invasive procedures. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.