Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome

Inclusion Criteria:

• Adults, aged 18-60 years, who are able to provide written, informed consent.

• Patients must meet Rome IV criteria for IBS, confirmed by a gastroenterologist whospecializes in functional GI disorders. Any of the IBS bowel habit subtypes (diarrhea, constipation, mixed bowel habits, unclassified) will be allowed.

• Average daily worst abdominal pain score between 4 and 8 (on a 0-10-point ratingscale).

• Minimum of 2 days of abdominal pain/week prior to starting trial.

• At least moderate IBS symptom severity with an IBS-SSS of at least 175 (total scorerange 0-500).

• If receiving pharmacologic therapy for abdominal pain associated with IBS, dosesmust be stable for at least 60 days prior to enrollment in the trial.

• If receiving pharmacologic therapy for IBS that does not have an effect on abdominalpain, doses must be stable for at least 30 days prior to enrollment in the trial.

Mandatory Exclusion Criteria:

• Patients under the age of 18 years or over the age of 60 years

• Patients who cannot provide informed consent or do not speak English

• Co-morbid, organic medical conditions associated with abdominal pain, including:Inflammatory bowel disease, chronic liver disease, peptic ulcer disease, celiacdisease, diverticulitis, appendicitis, colorectal cancer, endometriosis, pregnancy,other intestinal or extra-intestinal malignancies. Patients with overlappingfunctional GI disorders (i.e. functional dyspepsia) will not be excluded as long asIBS is their predominant disorder

• History of surgery involving CN V, VII, IX, or X.

• History of abdominal surgeries other than appendectomy or cholecystectomy at least 6months before entry into trial.

• Patients on chronic opioids, benzodiazepines, or with illicit substance use

• Patients with underlying neurologic conditions, including history of: seizures, CVA,uncontrolled migraines, traumatic brain injury, multiple sclerosis

• Patients with underlying psychiatric conditions

• Patients with dermatologic conditions affecting the ear, face, or neck region (i.e.psoriasis), or with cuts or abrasions to the external ear that would interfere withneedle placement

• Patients with hemophilia or other bleeding disorders

• Patients with any implanted electrical device

• Patients who are pregnant or breastfeeding

Preferred, but not mandatory, exclusion criteria:

• Movement disorder

• Unwillingness to wear the SmartWatch on upper extremity (left or right wrist)