IB-Stim is a different kind of approach for patients (8-21 years) with functional abdominal pain and IBS.

Functional abdominal pain associated with IBS is believed to involve abnormal processing between the brain and the gut, otherwise known as the “brain-gut axis”1.

Studies in individuals with “Irritable Bowel Syndrome (IBS)” have demonstrated abnormal activation of an area in the brain called the amygdala. The amygdala is part of the brain that controls the autonomic nervous system and is involved in processing of fear and pain2-4.

IB-Stim targets the central nervous system by sending gentle electrical impulses through the peripheral cranial nerve branches located just beneath the skin in the ear.

While the exact mechanism of action for IB-Stim has not been demonstrated in humans, pre-clinical studies suggest it works by controlling activity of pain areas in the central nervous system, particularly the amygdala and spinal cord5.

IB-Stim Device

Activity of neurons in the Amygdala is decreased after 15 minutes electrical stimulation*

65%

65% Reduction In Amygdala Firing.

*Based on pre-clinical study using the exact same parameters of stimulation (3.2V with 1 and 10 Hz) Babygirlja R, et.al., Neuroscience. 2017;356:11-21/ #p<0.05 compared to baseline.

IB-Stim and functional abdominal pain in adolescents – how does it work?

Ver la versión en español del vídeo.

Important Safety Information

Contraindications

A healthy, clean, intact skin surface is essential for the use of IB-Stim stimulator. IB-Stim is contraindicated in patients with:

  • A cardiac pacemaker because no clinical data are available

  • Hemophilia
  • Psoriasis

Safety

  • No safety data exists in patients (8-21 y/o) treated longer than 4 weeks with IB-Stim.

  • There have been no serious adverse events reported with treatment.
  • Mild ear discomfort in 2.8% with active treatment
  • Adhesive allergy in 2.8% with active treatment
  • Fainting due to needle phobia 0.9% in placebo

Indications For Use

The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.

DeNovo Number: DEN180057

References:

A New Standard Of Care

*The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS DEN180057.