TRANSTIMULATION RESEARCH INC — Department of Health and Human Services SBIR Phase I: R

Description

DESCRIPTION provided by applicant Systemic sclerosis scleroderma SSc is a chronic autoimmune disease characterized by proliferative vascular lesions with resultant fibrosis of skin and other multiple organs including the gastrointestinal GI tract In the United States the prevalence of SSc is about per million in adults Up to of SSc patients are reported to have upper and lower GI involvement as major visceral manifestation Severe GI involvement results in reduced quality of life in physical and social dimensions Currently there are no satisfactory treatment options for GI complications of SSc An innovative method of needleless transcutaneous electroacupuncture TEA using a newly developed watch size stimulator is proposed Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to GI functions The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of SSc First an acute clinical study will be performed in patients with SSc to derive best stimulation parameters Then a double blind cross over chronic study is designed to investigate the efficacy of TEA in treating gastric complications of SSc using a validated GI instrument As secondary measures mechanistic data will also be obtained to test the following hypotheses SSc leads to sympathetic overactivity and elevation in the immunological cytokine interleukin IL tumor necrosis factor alpha TNF interleukin beta IL and the gut hormone vasoactive intestinal peptides VIP resulting in impaired gastrointestinal motility TEA normalizes sympathovagal balance and reduces inflammatory cytokines and VIP resulting in improvement in gastric motility as well as the overall symptoms of the entire gut quality of life and SSc symptoms All diagnostic and therapeutic methods used in this project are noninvasive and therefore the proposed therapy will be well received by patients and physicians once its efficacy is proven While the physiological measurements are limited to gastric complications the efficacy of the proposed TEA in treating symptoms of the entire gut will be carefully assessed using an instrument validated in patients with SSc A comprehensive team has been assembled to perform the study including researchers in traditional Chinese medicine bio medical engineers a rheumatologist with expertise in SSc and a gastroenterologist with expertise in gastrointestinal motility An excellent partnership has been established between the company that has cutting edge technologies in neuromodulation device development and the university with one of the best and largest scleroderma centers in the world PUBLIC HEALTH RELEVANCE In this project we propose a noninvasive therapy for treating gastric complications in patients with systemic sclerosis A watch size device wearable at arms or legs will be used to deliver weak electrical current via skin surface electrodes to certain acupuncture points in the arms and legs