Current IB-Stim Publications

  • Clinical Gastroenterology and Hepatology

    August 18, 2020

    Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial.

    This randomized, sham controlled trial compared active treatment with PENFS device (Neuraxis) to a sham device. Included only adolescents with irritable bowel syndrome (IBS). Validated questionnaires for pain, global symptoms and functional disability were administered to both groups at baseline, weekly intervals and 2-3 months post treatment.

    Baseline findings

    1. The cohort include 50 patients with IBS (27 received active treatment vs. 23 sham).
    2. 70-91% of patients in the study had failed to respond to medication therapy.

    Post-PENFS treatment

    1. Overall, 59% of patients receiving active PENFS therapy compared with 26% of patients receiving sham showed ≥30% reduction in worst abdominal pain from baseline.
    2. The number needed to treat (NNT) to get the targeted 30% improvement in worst pain severity was 3.
    3. 81% of IBS patients in the active PENFS group compared with 26% of the sham (P < .001) reported overall symptom improvement, respectively using a higher cutoff score of ≥
    4. There were no significant adverse events.

    Significance

    1. The first and only randomized controlled trial with a PENFS device in adolescents with IBS.
    2. Results were the first to show the benefit of PENFS compared to sham device in adolescents with IBS.
    3. Pain and global symptom measures remained improved when evaluated at long-term follow-up (2-3 months) post treatment compared to sham.

  • The Lancet

    October 2, 2017

    Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial

    This randomized, sham controlled trial compared active treatment with PENFS device (Neuraxis) to a sham device that looked the same but without electrical current.  Validated questionnaires for pain, global symptoms and functional disability were administered to both groups at baseline, weekly intervals and 2-3 months post treatment.

    Baseline findings

    1. The cohort include 115 patients (49% had IBS and 26% had functional dyspepsia).
    2. 0verall, 63-86% of patients in the study had failed to respond to medication therapy.
    3. The median functional disability index (FDI) scores for both the PENFS and sham groups were in the moderate disability range at baseline.

    Post-PENFS treatment

    1. Overall, 60% in the active device group had a reduction in worst pain of ≥ 30% compared with 22% in the sham group (p=0.00031).
    2. Patients in the active device group reported feeling better based on the symptom response scale (SRS). 73% in the active device versus 35% in the sham group had SRS scores of 2 or more after 3 weeks of therapy (p=0·00022).
    3. At long-term follow-up, the active device group decreased to the minimal disability range, whereas the sham group remained in the moderate disability range.
    4. There were no significant adverse events.

    Significance

    1. One of only a few randomized controlled trials in children with chronic abdominal pain and the only device trial.
    2. Results were the first to show the benefit of PENFS compared to sham (placebo) in abdominal pain, global symptoms, and disability. It included children with IBS, functional dyspepsia, abdominal migraine, and functional abdominal pain syndrome.
    3. Pain and disability measures remained improved when evaluated at long-term follow-up (2-3 months) post treatment compared to sham.

  • Neuroscience

    July 25, 2017

    Percutaneous electrical nerve field stimulation modulates central pain pathways and attenuates post-inflammatory visceral and somatic hyperalgesia in rats.

    The study is a pre-clinical study in animals that investigated visceral pain changes before and after PENFS in an animal model of irritable bowel syndrome. The animals received daily PENFS therapy for 4hrs per day, for a total of 5 days compared to a sham (inactive) device.

    Baseline findings

    1. After colonic inflammation, animals developed a visceral hypersensitivity to mechanical distension.
    2. After colonic inflammation, there was also an increase in somatic sensitivity (compression of the hind paw).
    3. Electrophysiology recordings from single neurons of the spinal cord and central nucleus of the amygdala showed normal baseline activity and increase to mild compression of the paw.

    Post-PENFS treatment

    1. PENFS prevented the development of visceral hyperalgesia if applied at the same time the colon was inflamed.
    2. PENFS decreased post-inflammatory visceral and somatic hyperalgesia compared to sham.
    3. A significant decrease in baseline activity of spinal (47%) and amygdala (57%) neurons was observed 15 minutes after PENFS device was applied.

    Significance

    1. This is the first report demonstrating that the development of post-inflammatory visceral and somatic hyperalgesia can be altered by PENFS.
    2. The results also show that the response characteristics of amygdala and lumbar spinal neurons can be modulated by the PENFS.

  • Dovepress

    November 3, 2016

    Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study.

    Coming Soon

This page discusses ongoing research activities with percutaneous electrical nerve field stimulator (PENFS) technology. This information is intended for healthcare providers, who may have interest in furthering research and development with PENFS as well as payors, government bodies and review committees, who are seeking information about the product to help them make their own decisions, on a case by case basis about coverage, only. Please note, the research being described may include information about technology and intended uses of that technology which have not been reviewed or approved/cleared by the U.S. FDA, and is being provided for informational purposes only. NeurAxis does not recommend or suggest the use of its PENFS IB-Stim device for uses beyond those that are cleared by the U.S. FDA.

A New Standard Of Care

*The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 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 up to 3 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.