Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome
Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome
This is a prospective, double-blind, randomized, sham-controlled pilot study evaluating the
 efficacy of percutaneous electrical nerve field stimulation for the treatment of adult
 patients with irritable bowel syndrome (IBS).
IBS has a worldwide prevalence around 11% and is characterized by chronic or recurrent
 abdominal pain associated with altered bowel habits. Abnormalities within the brain-gut axis,
 visceral hypersensitivity, and dysfunction of the autonomic nervous system are important
 components contributing to the pathophysiology of IBS. Despite recent advances in medical
 therapies for IBS, a significant subgroup of patients fails to experience satisfactory relief
 of abdominal pain. Given evidence of anti-inflammatory and anti-nociceptive components of
 vagal nerve pathways, peripheral field stimulation of the vagus nerve may help reduce
 abdominal pain in patients with IBS.

 Percutaneous electrical nerve field stimulation (PENFS) administered via the IB-Stim device
 (Innovative Health Solutions, Versailles, IN, USA) has been shown to be efficacious in
 adolescent patients with abdominal-pain-related functional GI disorders, including IBS. This
 device uses discontinuous frequencies of stimulation to target central pain pathways through
 branches of cranial nerves V, VII, IX, and X that innervate the external ear and project to
 certain brainstem nuclei, including the nucleus tractus solitarius (NTS). The NTS then acts
 as a relay station to other brain areas involved in pain modulation and autonomic control,
 including the rostral ventral medulla, locus coeruleus, hypothalamus, and amygdala. In
 adolescent studies, PENFS was associated with a greater reduction in worst abdominal pain and
 composite abdominal pain scores from baseline as well as compared with a sham device after
 three weeks of treatment. These effects were sustained over an extended follow-up period with
 minimal to no side effects. In addition, a greater proportion of adolescents in the PENFS arm
 achieved at least a 30% reduction in worst abdominal pain scores from baseline after 3 weeks
 of treatment.

 The IB-Stim is the first device to be approved by the Food and Drug Administration (FDA) for
 the treatment of functional abdominal pain in adolescents aged 11-18 with IBS. However, the
 efficacy of PENFS in adults with IBS is not currently known. This study is a double-blind,
 randomized, sham-controlled pilot study evaluating the efficacy of PENFS using IB-Stim for
 the treatment of IBS symptoms in adult patients with IBS.
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 who
 specializes 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 rating
 scale).

 -  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 score
 range 0-500).

 -  If receiving pharmacologic therapy for abdominal pain associated with IBS, doses must
 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 abdominal
 pain, 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, celiac
 disease, diverticulitis, appendicitis, colorectal cancer, endometriosis, pregnancy,
 other intestinal or extra-intestinal malignancies. Patients with overlapping
 functional GI disorders (i.e. functional dyspepsia) will not be excluded as long as
 IBS 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 6
 months 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 with
 needle 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)