Cranial Nerve Stimulator Relieves Abdominal Pain

A new non-surgical device sends gentle electrical impulses into cranial nerve bundles located around the ear to reduce the abdominal pain associated with irritable bowel syndrome (IBS).

The Innovative Health Solutions (IHS; Versailles, IN, USA) IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended for patients 11-18 years of age with functional abdominal pain related with IBS. The device is applied behind the ear, with small electrodes placed to stimulate branches of cranial nerves V, VII, IX and X, and the occipital nerves; the precise nerve locations are identified by transillumination. While the exact mechanism of action is unclear, it is hypothesized the system works by controlling activity of pain areas in the central nervous system (CNS), particularly the amygdala and spinal cord.

The prescription-only device contains a battery-powered chip that emits low-frequency electrical pulses to stimulate the cranial nerves branches continuously for five days (120 hours) per week, at which time it is replaced. Patients can use the device for up to three consecutive weeks, in conjunction with other modalities for treatment of chronic abdominal pain, including medication. IB-Stim is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris, a condition in which skin cells build up and form scales and itchy, dry patches.

“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” said Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices at the FDA Center for Devices and Radiological Health (CDRH). “Today’s action reflects our ongoing commitment to advancing the development of pediatric medical devices so that children and adolescents have access to safe and effective medical devices that meet their needs.”

IBS is a diagnosis of exclusion. It is a functional bowel disorder characterized by chronic abdominal pain, discomfort, bloating, and alteration of bowel habits in the absence of any detectable organic cause. Sometimes, the painful symptoms are relieved by bowel movements. Diarrhea or constipation may predominate, or they may alternate (classified as IBS-D, IBS-C or IBS-A, respectively). IBS may begin after an infection (post-infectious, IBS-PI), a stressful life event, or onset of maturity without any other medical indicators.

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