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 240 per million in adults. Up to 90% 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: 1) SSc leads to sympathetic overactivity and elevation in the immunological cytokine, interleukin-6 (IL-6), tumor necrosis factor alpha(TNF?), interleukin-1 beta (IL-1?) and the gut hormone, vasoactive intestinal peptides (VIP), resulting in impaired gastrointestinal motility; 2) 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.
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.
