Neuromodulation With Percutaneous Electrical Nerve Field Stimulation

Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With Gastroparesis Like Symptoms: A Randomized, Double-Blind, Sham-Controlled Pilot Study

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 Percutaneous electrical nerve field stimulation (PENFS) in adults with gastroparesis like symptoms (GPLS) is not currently known. This study is a double-blind, randomized, sham-controlled pilot study evaluating the efficacy of PENFS using IB-Stim in adult patients with GPLS. A secondary aim will be to assess whether treatment with PENFS is associated with changes in autonomic function via heart rate variability.

Inclusion Criteria:

• Ability to provide written, informed consent

• Patients who meet Rome IV criteria for Functional Dyspepsia (FD), with or without a delay in gastric emptying:

  • One or more of the following: Bothersome postprandial fullness, Bothersome early satiation, Bothersome epigastric pain, Bothersome epigastric burning
  • No evidence of structural disease that is likely to explain the symptoms
  • Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

• Average daily worst abdominal pain score between 4 and 8 (on a 0-10-point rating scale) during the screening period. A minimum reporting of abdominal pain will be required for 5/7 days in the baseline period.

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

• At least moderate symptom severity with a GCSI score of at least 2.0 during screening

• If receiving pharmacologic therapy for abdominal pain associated with GPLS, doses must be stable for at least 60 days prior to randomization.

• If receiving pharmacologic therapy for GPLS that does not have an effect on abdominal pain, doses must be stable for at least 30 days prior to randomization.

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. IBS) will not be excluded as long as GPLS is their predominant disorder
• Patients prescribed GLP-1s
• History of surgery involving Cranial Nerves V, VII, IX, or X.
• History of abdominal surgeries other than appendectomy or cholecystectomy at least 6 months before the screening visit.
• Patients with chronic opioid, benzodiazepine, or illicit substance use within the last 6 months.
• Patients with underlying neurologic conditions, including history of: seizures, CVA, uncontrolled migraines, traumatic brain injury, multiple sclerosis
• Patients with severe, uncontrolled psychiatric conditions, including severe major depression, psychosis, dissociative episodes, etc.
• 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 known to be pregnant or breastfeeding