Home-based transcutaneous electrical acustimulation for abdominal pain

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Abdominal pain is the main symptom in patients with the irritable bowel syndrome (IBS) that is the most common gastrointestinal disorder affecting 14-20% of the US population. More than 40% of patients with IBS regularly use opioid narcotics. Currently no adequate therapies are available for pain in patients with IBS. Acupuncture or electroacupuncture (EA) has been shown to be effective for pain management and may have a potential for treating pain against opioid crisis; however, it has drawbacks of infrequent administration, lack of optimization in methodology and unclear mechanisms. In this study, we propose a noninvasive method of transcutaneous electrical acustimulation (TEA) by replacing needles with surface electrodes and by choosing a few acupoints in the vicinity of peripheral nerves. The proposed TEA is based on a number of previous basic mechanistic researches and clinical studies. Methodologically, two effective sets of stimulation parameters and two effective acupoints have been derived for treating visceral hypersensitivity. Mechanistically, appropriate TEA has been shown to improve autonomic functions that are impaired in IBS. Clinically, the proposed TEA can be self-administrated at home/work and therefore daily treatment is feasible, which greatly improves its efficacy. During the UG3 phase, an existing TEA device will be modified for treating chronic abdominal pain in IBS. First, a special cellphone app will be developed 1) to keep a history of each treatment, which is critical in assessing therapy compliance, and 2) to collect and store major treatment outcomes daily and weekly, and transit these information (de-identified) to a server automatically; this will minimize missing or loss of critical treatment outcome information and will be useful for future data mining and therapy refinement. Secondly, an acute clinical physiological test will be performed to derive best stimulation locations and parameters. During the UH3 phase, an early feasibility clinical study will be performed in 160 patients with IBS. While the primary aim is to investigate the therapeutic potential of the proposed TEA in treating abdominal pain in IBS, the study is also designed to identify subgroups of patients (mild pain vs. moderate pain; constipation vs. diarrhea) who may respond to TEA for a future large scale clinical study and to compare the analgesic effect and autonomic mechanisms between the electrical neuromodulation therapy (TEA) and a medical neuromodulation therapy (pharmacological neuromodulators). A comprehensive team has been assembled, including experts in neuromodulation, abdominal pain, IBS, device development and regulatory affairs. The project results from a close collaboration between a strong academic center in managing visceral pain and IBS, and a start-up company devoted to bringing the proposed novel therapy to patients and hospitals.