Transformation of dormant spinal networks to mitigate symptoms of neurogenic bladder

The Spinex Inc. was awarded a $4,719,091 Project Grant from the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases to develop and clinically validate a transcutaneous electrical spinal cord neuromodulation (TESCON) device to mitigate symptoms of neurogenic bladder resulting from spinal cord injury. The award, made under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), will support Spinex in building a commercial version of their TESCON prototype, and conducting a multicenter randomized controlled trial to evaluate the device's effects on managing lower urinary tract function in individuals with spinal cord injuries. Specifically, the trial aims to demonstrate TESCON's ability to improve bladder capacity, diminish urinary incontinence, and restore bladder sensation. Successful completion of this clinical study will provide evidence to support a 510(k) submission to the FDA. The two-year project period began August 15, 2021.

Abstract

Spinal cord injury invariably leads to severe dysfunction of the lower urinary tract; patients develop urinary incontinence, recurrent urinary tract infections, incomplete bladder emptying and high bladder pressures. Reliance on catheters to empty the bladder is virtually universal. Established therapies for lower urinary tract dysfunction due to spinal cord injury focus on preventing and managing complications rather than on restoring function. Relying on our years of experience in rehabilitation of motor function after paralysis, we are confident that we can change the paradigm of bladder care in individuals with spinal cord injuries as well. Transcutaneous electrical spinal cord neuromodulation (TESCON) offers a diametrically different approach to classic therapies for neurogenic bladder: by delivering low-intensity sub-motor threshold electrical pulses to the spinal cord, TESCON activates lumbar neural networks rendered dysfunctional by the spinal cord injury and restores some communication between the lower urinary tract and higher neural centers responsible for micturition control. Results from our preliminary studies indicate that TESCON-mediated neuromodulation improves bladder capacity, diminishes urinary incontinence and, remarkably, restores bladder sensation even in individuals, whose spinal cord injury is considered clinically complete. In this phase II application, we propose to build a commercial version of the TESCON prototype under design controls and use the device in a clinical validation study. We propose a multicenter randomized control trial to demonstrate the beneficial effects of TESCON on the paralyzed lower urinary tract. By recruiting sixty individuals with spinal cord injury and comparing the effects of sham and true stimulation on their lower urinary tract, we aim to show that TESCON has a significant role in managing and rehabilitating urinary function in the clinical setting (primary outcome). The academic roots of our company and the team we have assembled (engineers, entrepreneurs and clinicians) ensure that our study design, implementation and analysis will be both impactful and rigorous. Successful completion of this study will provide evidence for a FDA 510(K) submission. Finally, if TESCON is successful in the case of a neurological impairment as devastating as a spinal cord injury, we are confident that we will be able to bring this technology to a much larger population of patients suffering from lower urinary tract dysfunction due to both neurological and non-neurological conditions, such as stroke, multiple sclerosis, parkinson's disease and idiopathic overactive bladder.