Current IB-Stim Publications

  • Frontiers in Pain Research

    September 19, 2023

    Percutaneous electrical nerve field stimulation compared to standard medical therapy in adolescents with functional abdominal pain disorders.

    Coming Soon

  • Frontiers in Pain Research

    September 8, 2023

    Prospective study of the effect of auricular percutaneous electrical nerve field stimulation on quality of life in children with pain related disorders of gut-brain interaction.

    Coming Soon

  • Neurogastroenterology and Motility

    July 1, 2023

    The microbiome in adolescents with irritable bowel syndrome and changes with percutaneous electrical nerve field stimulation.

    Coming Soon

  • Journal of Digestive Diseases

    May 24, 2023

    Impact of auricular percutaneous electrical nerve field stimulation on gut microbiome in adolescents with irritable bowel syndrome: A pilot study

    This study looked at validated measures at weekly intervals and stool was collected from subjects at baseline, at the end of treatment and 2-3 months post treatment with the Neuraxis PENFS device for microbiome analysis.

    Baseline findings

    1. Clostridial species in the intestines that have been implicated in gastrointestinal pro-inflammatory states, were higher in children with IBS compared to healthy controls.
    2. Microbial metabolic pathways involving long chain fatty acids were higher in children with IBS compared to healthy controls.

    Post-PENFS treatment

    1. Consistent with other studies, PENFS improved abdominal pain, functional disability, and pain catastrophizing in children with IBS.
    2. Treatment with PENFS decreased intestinal Clostridial species in children with IBS.
    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. Treatment with PENFS also decreased long chain fatty acid synthesis pathways.

    Significance

    1. Study validates previous studies with symptom improvement after 4 weeks of treatment.
    2. Results add evidence that the microbiome and microbial metabolic pathways in children with IBS are different than healthy controls.
    3. Study suggests that PENFS may have an additional benefit of altering the microbiome and/or microbial metabolic pathways through modulation of the brain-gut axis.

  • Neurogastroenterology and Motility

    August 3, 2022

    Effect of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents with functional abdominal pain disorders.

    This study is an open-label, real world study that included 11–19 years olds with functional abdominal pain requiring PENFS as part of their standard care. A water Load Symptom Provocation Task (WL-SPT) before and after four weeks of treatment was done to test changes in evoked pain. Validated questionnaires to assess abdominal pain, gastrointestinal symptoms, sleep, somatic symptoms, and physical and psychological functioning were assessed before and after treatment and 6-12 months post treatment. Actigraphy was used to measure daily sleep–wake patterns.

    1. 60% of patients in the study had failed medications.
    2. The average duration of symptoms before treatment was 27.5 months.
    3. 90% met criteria for functional dyspepsia.

    Post-PENFS treatment

    1. Abdominal pain improved from baseline and continued to be statistically significant at 6-12 months post treatment based on the abdominal pain index (API), p<0.0001.
    2. Pain intensity immediately post Water Load-SPT was lower compared to pre-treatment (p = 0.004) but not different at 5 and 10 min.
    3. Nausea improved from baseline and continued to be statistically significant at 6-12 months post treatment based on the nausea severity scale (NSs), p=0.001.
    4. Functional disability improved from baseline and continued to be statistically significant at 6-12 months post treatment based on the functional disability index (FDI), p<0.0001.
    5. Pain catastrophizing improved from baseline and continued to be statistically significant at 6-12 months post treatment based on the pain catastrophizing scale for children (PCS-C), p=0.001.
    6. Anxiety improved from baseline and continued to be statistically significant at 6-12 months post treatment based on the Screen for Child Anxiety-Related Emotional Disorders (SCARED), p<0.03.
    7. Patients reported a significant decrease in sleep-related impairments (PROMIS-SRI, p = 0.005) and disturbances (PROMIS-SD), p = 0.01.
    8. Actigraphy measures of sleep onset latency showed a significant decrease from week 1 to week 4 of PENFS (p = 0.03), but other actigraphy variables did not change.
    9. There were no significant adverse events.

    Significance

    1. PENFS appeared to blunt the increase in visual analogue scale pain intensity seen immediately after Water Load-SPT
    2. The study shows for the first time that PENFS is associated with changes in mechanosensitivity and improvements in sleep, and psychological factors like catastrophizing and anxiety.
    3. The changes in abdominal pain, nausea, and psychological measures were also sustained for 6–12 months post-treatment.

  • American Journal of Gastroenterology

    September 11, 2020

    Impaired Vagal Efficiency Predicts Auricular Neurostimulation Response in Adolescent Functional Abdominal Pain Disorders.

    This study aimed to investigate whether baseline EKG measures of vagal efficiency/insufficiency could predict responders to PENFS therapy. Data were drawn from a 4-week prospective, randomized controlled trial comparing PENFS to a sham device in adolescents with functional abdominal pain disorders.

    Baseline findings

    1. Vagal efficiency was not predictive of pain at baseline.
    2. Treatment and sham groups did not differ in baseline pain.

    Post-PENFS treatment

    1. There was no change in sham or treatment group subjects with high vagal efficiency.
    2. Treatment group subjects with low and moderate baseline vagal efficiency had reduced pain scores after 3 weeks of treatment with active PENFS.

    Significance

    1. Adolescents with functional abdominal pain and reduced VE have greater improvement in abdominal pain after only 3 weeks of PENFS compared with sham.
    2. Functional abdominal pain disorders may involve abnormal autonomic control.

    The effects of PENFS therapy may be strongest in those individuals with suboptimal autonomic control (vagal insufficiency).

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.