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Completed

NCT Number: NCT04428619

Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome

This is a prospective, double-blind, randomized, sham-controlled pilot study evaluating the efficacy of percutaneous electrical nerve field stimulation for the treatment of adult patients with irritable bowel syndrome (IBS).

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Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Autonomic Nervous System Imbalance Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

IBS has a worldwide prevalence around 11% and is characterized by chronic or recurrent abdominal pain associated with altered bowel habits. Abnormalities within the brain-gut axis, visceral hypersensitivity, and dysfunction of the autonomic nervous system are important components contributing to the pathophysiology of IBS. Despite recent advances in medical therapies for IBS, a significant subgroup of patients fails to experience satisfactory relief of abdominal pain. Given evidence of anti-inflammatory and anti-nociceptive components of vagal nerve pathways, peripheral field stimulation of the vagus nerve may help reduce abdominal pain in patients with IBS.

Percutaneous electrical nerve field stimulation (PENFS) administered via the IB-Stim device (Innovative Health Solutions, Versailles, IN, USA) has been shown to be efficacious in adolescent patients with abdominal-pain-related functional GI disorders, including IBS. This device uses discontinuous frequencies of stimulation to target central pain pathways through branches of cranial nerves V, VII, IX, and X that innervate the external ear and project to certain brainstem nuclei, including the nucleus tractus solitarius (NTS). The NTS then acts as a relay station to other brain areas involved in pain modulation and autonomic control, including the rostral ventral medulla, locus coeruleus, hypothalamus, and amygdala. In adolescent studies, PENFS was associated with a greater reduction in worst abdominal pain and composite abdominal pain scores from baseline as well as compared with a sham device after three weeks of treatment. These effects were sustained over an extended follow-up period with minimal to no side effects. In addition, a greater proportion of adolescents in the PENFS arm achieved at least a 30% reduction in worst abdominal pain scores from baseline after 3 weeks of treatment.

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 PENFS in adults with IBS is not currently known. This study is a double-blind, randomized, sham-controlled pilot study evaluating the efficacy of PENFS using IB-Stim for the treatment of IBS symptoms in adult patients with IBS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults, aged 18-60 years, who are able to provide written, informed consent.
  • Patients must meet Rome IV criteria for IBS, confirmed by a gastroenterologist who specializes in functional GI disorders. Any of the IBS bowel habit subtypes (diarrhea, constipation, mixed bowel habits, unclassified) will be allowed.
  • Average daily worst abdominal pain score between 4 and 8 (on a 0-10-point rating scale).
  • Minimum of 2 days of abdominal pain/week prior to starting trial.
  • At least moderate IBS symptom severity with an IBS-SSS of at least 175 (total score range 0-500).
  • If receiving pharmacologic therapy for abdominal pain associated with IBS, doses must be stable for at least 60 days prior to enrollment in the trial.
  • If receiving pharmacologic therapy for IBS that does not have an effect on abdominal pain, doses must be stable for at least 30 days prior to enrollment in the trial.

Mandatory 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. functional dyspepsia) will not be excluded as long as IBS is their predominant disorder
  • History of surgery involving CN V, VII, IX, or X.
  • History of abdominal surgeries other than appendectomy or cholecystectomy at least 6 months before entry into trial.
  • Patients on chronic opioids, benzodiazepines, or with illicit substance use
  • Patients with underlying neurologic conditions, including history of: seizures, CVA, uncontrolled migraines, traumatic brain injury, multiple sclerosis
  • Patients with underlying psychiatric conditions
  • 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 pregnant or breastfeeding

Preferred, but not mandatory, exclusion criteria:

  • Movement disorder
  • Unwillingness to wear the SmartWatch on upper extremity (left or right wrist)

Treatment and study plan

Peripheral Electrical Nerve Field Stimulation (PENFS) Device

Device

Patients will complete daily worst abdominal pain and bowel habit questionnaires for 1 week prior to initial PENFS device placement to provide a baseline. At visit 1, patients will complete the Bowel Symptom Questionnaire, IBS Symptom Severity Scale (IBS-SSS), PROMIS Belly Pain Scale, Gas and Bloating, Constipation, and Diarrhea Scales, Hospital Anxiety and Depression Scale, and Visceral Sensitivity Index, heart rate variability will be measured, and they will have the initial PENFS device placed. Patients will complete daily worst abdominal pain (scale 0-10) questionnaires throughout the duration of the study. They will return every 7 days for a total of 4 visits for device replacement and additional questionnaires, including the IBS-SSS. Four devices will be placed in total (start of weeks 1, 2, 3, and 4). Stimulation time is 5 days/week during each of the 4 consecutive weeks. Additional questionnaires will be completed at the end of week 4 and at extended follow-up (8 weeks).

Sham device

Device

Patients will complete daily worst abdominal pain and bowel habit questionnaires for 1 week prior to initial sham device placement to provide a baseline. At visit 1, patients will complete the Bowel Symptom Questionnaire, IBS Symptom Severity Scale (IBS-SSS), PROMIS Belly Pain Scale, Gas and Bloating, Constipation, and Diarrhea Scales, Hospital Anxiety and Depression Scale, and Visceral Sensitivity Index, heart rate variability will be measured, and they will have the initial sham device placed. Patients will complete daily worst abdominal pain (scale 0-10) questionnaires throughout the duration of the study. They will return every 7 days for a total of 4 visits for device replacement and additional questionnaires, including the IBS-SSS. Four devices will be placed in total (start of weeks 1, 2, 3, and 4). Stimulation time is 5 days/week during each of the 4 consecutive weeks. Additional questionnaires will be completed at the end of week 4 and at extended follow-up (8 weeks).

Primary outcomes

  1. Mean Change in IBS Symptom Severity From Baseline

    Time frame: 4 weeks, 8 weeks.

    To compare the efficacy of PENFS therapy versus sham therapy on the change in IBS symptom severity in adult IBS patients after 4 weeks of treatment and at extended follow-up (8 weeks), assessed through a mean change in the IBS-SSS between groups. Answers were measured using the IBS-SSS. Higher scores indicate worse symptoms. The score range is 0-500.

Secondary outcomes

  1. Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 4 Weeks.

    Time frame: 4 weeks

    Same measures as outcome measure 12. LF peak FFT: Peak frequency within the low-frequency range (typically 0.04-0.15 Hz) of the HRV spectrum HF peak FFT: Peak frequency within the high-frequency range (typically 0.15-0.4 Hz) of the HRV spectrum.

    VLF peak AR: Peak frequency within the very-low-frequency range (typically 0.0033-0.04 Hz) of the HRV spectrum.

    HF peak AR: Peak frequency within the high-frequency range of the HRV spectrum. LF peak AR: Peak frequency within the low-frequency range of the HRV spectrum.

  2. IBS Symptom Severity Responder Rate

    Time frame: Week 4

    To compare the efficacy of PENFS therapy versus sham therapy on the change in IBS symptom severity in adult IBS patients after 4 weeks of treatment compared to baseline. Participants will be considered responders if there is at least a 50-point reduction on the IBS-SSS.

  3. Mean Change in Average Daily Worst Abdominal Pain From Baseline

    Time frame: Week 4

    To compare the efficacy of PENFS therapy versus sham therapy on mean worst daily abdominal pain scores after 4 weeks compared to baseline in adult patients with IBS. The scale is measured as follows, with higher scores indicating worse pain:

    Daily Worse Abdominal Pain Severity:

    • How would you rate your worst abdominal pain over the past 24-hours (0-10)?

    o 0 = no pain, 10= worst pain possible

  4. Change in Average Daily Stool Consistency From Baseline

    Time frame: Week 4

    To compare the efficacy of PENFS therapy versus sham therapy on the change in average daily stool consistency after 4 weeks of treatment compared to baseline, assessed using the Bristol Stool Form Scale (BSFS) (stool types 1-7; types 1 and 2 indicate constipation, types 3 and 4 are normal consistency stools, type 5 indicates stool lacking fiber, types 6 and 7 indicate diarrhea).

  5. Change in Average Weekly Bowel Habits From Baseline

    Time frame: Week 4, week 8

    To compare the efficacy of PENFS therapy versus sham therapy on the change in average weekly bowel habits after 4 weeks of treatment and at extended follow-up (8 weeks) compared to baseline, assessed through the PROMIS Gastrointestinal Constipation Scale (percentiles 0.3-100%; higher percentiles indicate greater constipation).

  6. Change in Quality of Life From Baseline

    Time frame: Week 4, week 8

    To compare the efficacy of PENFS therapy versus sham therapy on the change in IBS-quality of life (IBS-QOL) in adult patients with IBS after 4 weeks of treatment and at extended follow-up (8 weeks) compared to baseline. IBS QOL will be assessed on a scale from 0-100, with higher scores indicating better IBS specific quality of life.

  7. "Number of Participants With Treatment-related Adverse Events as Assessed by a Weekly Adverse Events Questionnaire

    Time frame: Week 4

    To compare the incidence of treatment-related adverse events from PENFS therapy versus sham therapy in adult patients with IBS. Adverse events will be assessed by a weekly adverse events questionnaire that determines the severity of the adverse event, the relationship to the study intervention, the action taken regarding the study intervention, the outcome of the adverse event, whether or not the adverse event was expected, and if the event was considered a serious adverse event (SAE).

  8. Change in Average Weekly Bloating Symptoms From Baseline

    Time frame: 4 weeks, 8 weeks

    To compare the efficacy of PENFS therapy versus sham therapy on the change in average weekly bloating symptoms at 4 weeks and at extended follow-up (8 weeks) compared to baseline, assessed through the PROMIS Gastrointestinal Gas and Bloating Scale (percentiles 0.1-100%; higher percentiles indicate greater gas and bloating).

  9. Change in Average Weekly Abdominal Pain Symptoms From Baseline

    Time frame: 4 weeks, 8 weeks

    To compare the efficacy of PENFS therapy versus sham therapy on the change in average weekly abdominal pain symptoms at 4 weeks and at extended follow-up (8 weeks) compared to baseline, assessed through the PROMIS Gastrointestinal Belly Pain Scale (percentiles 2-100%; higher percentiles indicate worse abdominal pain).

  10. Chang in Average Weekly Bowel Habits From Baseline

    Time frame: 4 weeks, 8 weeks

    To compare the efficacy of PENFS therapy versus sham therapy on the change in average weekly bowel habits after 4 weeks of treatment and at extended follow-up (8 weeks) compared to baseline, assessed through the PROMIS Gastrointestinal Diarrhea Scale (percentiles 1-100%; higher percentiles indicate greater diarrhea).

  11. Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at Baseline.

    Time frame: Baseline

    LF peak FFT: Peak frequency within the low-frequency range (typically 0.04-0.15 Hz) of the HRV spectrum, as determined by Fast Fourier Transform (FFT) analysis.

    HF peak FFT: Represents the peak frequency within the high-frequency range (typically 0.15-0.4 Hz) of the HRV spectrum, as determined by FFT analysis.

    VLF peak AR: Represents the peak frequency within the very-low-frequency range (typically 0.0033-0.04 Hz) of the HRV spectrum, as determined by autoregressive (AR) modeling.

    HF peak AR: Represents the peak frequency within the high-frequency range of the HRV spectrum, as determined by AR modeling.

    LF peak AR: Represents the peak frequency within the low-frequency range of the HRV spectrum, as det

  12. Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at Baseline.

    Time frame: Baseline

    HF/LF ratio FFT: Ratio of high-frequency to low-frequency ratio in heart rate variability (HRV) analysis, as determined by FFT analysis. It reflects the balance between parasympathetic (HF) and sympathetic (LF) nervous system activity influencing heart rate.

    HF/LF ratio ACT: Ratio of high-frequency to low-frequency ratio in heart rate variability (HRV) analysis, as determined by AR modeling. It reflects the balance between parasympathetic (HF) and sympathetic (LF) nervous system activity influencing heart rate.

  13. Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 4 Weeks.

    Time frame: 4 weeks

    HF/LF ratio AR: Ratio of high-frequency to low-frequency ratio in heart rate variability (HRV) analysis, as determined by AR. It reflects the balance between parasympathetic (HF) and sympathetic (LF) nervous system activity influencing heart rate.

    HF/LF ratio FFT: Ratio of high-frequency to low-frequency ratio in heart rate variability (HRV) analysis; reflects the balance between parasympathetic (HF) and sympathetic (LF) nervous system activity influencing heart rate.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Innovative Health Solutions

Registry information

Official study title

Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome: A Randomized, Double-Blind, Sham-Controlled Pilot Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2020
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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