AccelBand, a leg-worn transcutaneous neuromodulation device for treating neurogenic bowel dysfunction in individuals with spinal cord injury

总结

SUMMARY Neurogenic bowel dysfunction (NBD) is manifested as a slow colonic motility and constipation, and it is the 2nd most common complication and 4th most common reason for re-hospitalization in people with spinal cord injury (SCI). More than 1/3 of people with SCI rate NBD as the most significant quality of life issue. To treat NBD, 43% of SCI individuals take laxatives despite the lack of clinical trials supporting their use. In addition, 65% of people with SCI resort to using stigmatizing, undignified, burdensome, and time-consuming bowel care procedures. Key pathophysiologies of NBD in SCI resulting from a loss of central neural control include: 1) prolonged colonic transit, 2) rectal hyposensitivity, and 3) anorectal dyssynergia. Progress in developing effective drug treatments for improving NBD has been slow, despite an urgent unmet need. Consequently, non-drug therapies, including transcutaneous neuromodulation (TNM), are have been explored for NBD. In our clinical studies, we discovered that TNM applied at the acupuncture point ST36 (below the kneecap) improves NBD in patients with stroke, chronic constipation, and other disorders by accelerating colonic transit, improving rectal sensitivity, and restoring colon - external anal sphincter synergy, with TNM effects mediated via the sacral parasympathetic activation. Anatomically, the ST36 acupuncture point is located at the cutaneous endings of the sacral nerves. Since direct stimulation of the sacral nerve and roots shown to improve NBD after SCI in 4 clinical studies, we hypothesize that TNM at ST36 is similarly capable of improving NBD in patients with SCI. We further hypothesize that therapeutic effects of TNM on the colonic transit would be mediated via the sacral parasympathetic pathway and on restoring the rectal sensitivity and colon - external anal sphincter synergy – via the sacral somatic pathway. The long-term goal of this project is to develop a novel noninvasive TNM therapy using a wearable device placed on ST36 acupuncture point for treating NBD in SCI and other neurological disorders. The specific aims of this project are to design and develop an easy-to-use leg-worn TNM device AccelBand and to evaluate its clinical potential in treating NBD in SCI.