H.12 Improving IBS Symptoms Through Neuromodulation

1. Functional gastrointestinal disorders are disorders of brain-gut interaction, with a hallmark feature of visceral hypersensitivity manifesting as abdominal discomfort or pain. Irritable bowel syndrome is the most common example of a functional GI disorder, affecting an estimated 10 to 15% of people in the United States. IBS can substantially affect a patient’s quality-of-life, and the condition can result in frequent utilization of the health care system due to persistent abdominal discomfort, diarrhea, and/or constipation. IBS-related symptoms account for over 3.6 million physician visits annually, with an estimated cost of $1.6 billion in direct medical care and indirect costs of about $20 billion in work absenteeism. Multiple factors contribute to the pathophysiology behind IBS, including abnormalities of intestinal motility, visceral hypersensitivity, GI tract inflammatory processes, the gut microbiome, peripheral enteric nerve signals, and psychological factors.

   Currently, the ideal approach to treating IBS is multimodal, with both pharmacologic and non-pharmacologic therapies. Dietary modifications and increased fiber are often recommended, with use of additional pharmacologic treatments as necessary. However, patient responses to these therapies vary widely, and many patients continue to experience symptoms that are refractory to medications and dietary changes. Recent studies have shown that non-pharmacologic interventions targeting enteric nerves and the brain-gut axis, including abdominal massage, acupuncture, hypnotherapy, cognitive behavioral therapy, and biofeedback, are beneficial to patients with refractory IBS. There are currently very few portable, wearable, or implantable devices that incorporate massage/vibration therapy, nerve stimulation, or continuous biofeedback monitoring to alleviate symptoms. The IB-Stim (https://ibstim.com) is available for pediatric patients with IBS; this delivers percutaneous electrical nerve field stimulation to the external ear to improve symptoms. Medtronic released Interstim (https://www.medtronic.com/us-en/patients/treatments-therapies/treatment-pathway/how-interstim-therapy-works.html) to improve symptoms in patients with fecal incontinence. Similar technology does not yet exist for adult patients with IBS.

   The goal of this project is to design a portable, wearable, or implantable device that utilizes vibration/massage therapy or nerve stimulation, or alternative non-pharmacologic biofeedback therapy in a low-cost manner, to improve quality-of-life in patients with IBS and reduce health care utilization. If successful, this tool could become part of the mainstay of treatment for patients with refractory IBS symptoms.