Irritable Bowel SyndromeNCT04428619
Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome
A study testing Peripheral Electrical Nerve Field Stimulation (PENFS) Device in people with Irritable Bowel Syndrome and Abdominal Pain, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irritable Bowel Syndrome, Abdominal Pain, Autonomic Nervous System Imbalance
- What is being tested?
- Peripheral Electrical Nerve Field Stimulation (PENFS) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 14 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 23Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome: A Randomized, Double-Blind, Sham-Controlled Pilot Study
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).
Read the detailed description
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.
- Being tested
- Peripheral Electrical Nerve Field Stimulation (PENFS) Device, Sham Device
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Electrical Nerve Field Stimulation (PENFS) DeviceDevice
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 DeviceDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Electrical Nerve Field Stimulation (PENFS) Device | Active comparator | The PENFS device has a battery activated generator and wire harness. Four leads are attached to the generator, each with a sterile 2 mm, titanium needle. The patient's ear is trans-illuminated to identify neurovascular bundles that are avoided during needle placement. The generator is attached with adhesive to the skin behind the patient's ear. Needles are inserted into the dorsal and ventral aspects of the ear, within 1-1.5 mm of the vascular branches to create a field effect. The device settings are standardized and deliver 3.2 volts with alternating frequencies (1 ms pulses of 1 Hz and 10 Hz) every 2 s. This stimulation targets central pain pathways through branches of cranial nerves V, VII, IX, and X, which innervate the external ear. The device is worn for 5 days/week for a total of 4 weeks. Patients remove devices at home on day 6 of each treatment cycle. Patients will be asked to wear a SmartWatch during the study to monitor heart rate. Receives: Device: Peripheral Electrical Nerve Field Stimulation (PENFS) Device |
| Sham Device | Sham comparator | The sham devices will be identical to the active devices but will not administer electrical charges. Per manufacturer design and patient anecdotal experience from previous studies, both active stimulation and sham are below detectable sensation threshold. Per report from previous studies, some patients may experience a sensation around the ear after percutaneous needle placement; however, this sensation can occur with equal likelihood in the active or sham device. The device is worn for 5 days a week for a total of 4 weeks. Patients remove devices at home on day 6 of each treatment cycle. Patients will also be asked to wear a SmartWatch as above. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in IBS Symptom Severity From Baseline
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.
Measured: 4 weeks, 8 weeks.
Secondary outcomes (13)
Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 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.
Measured: 4 weeks
IBS Symptom Severity Responder Rate
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.
Measured: Week 4
Mean Change in Average Daily Worst Abdominal Pain From Baseline
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)?
- 0 = no pain, 10= worst pain possible
Measured: Week 4
Change in Average Daily Stool Consistency From Baseline
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).
Measured: Week 4
Change in Average Weekly Bowel Habits From Baseline
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).
Measured: Week 4, week 8
Change in Quality of Life From Baseline
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.
Measured: Week 4, week 8
"Number of Participants With Treatment-related Adverse Events as Assessed by a Weekly Adverse Events Questionnaire
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).
Measured: Week 4
Change in Average Weekly Bloating Symptoms From Baseline
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).
Measured: 4 weeks, 8 weeks
Change in Average Weekly Abdominal Pain Symptoms From Baseline
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).
Measured: 4 weeks, 8 weeks
Chang in Average Weekly Bowel Habits From Baseline
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).
Measured: 4 weeks, 8 weeks
Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 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
Measured: Baseline
Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 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.
Measured: Baseline
Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Aug 2020
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Health Solutions
- Responsible party
- Principal investigator, Lin Chang, MD, University of California, Los Angeles
- Investigators
- Lin Chang, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428619
- Sponsor's protocol ID
- IRB# 19-001796
- Status last verified
- Apr 2025
- First submitted
- 28 May 2020
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.
PubMed 28826627Krasaelap A, Sood MR, Li BUK, Unteutsch R, Yan K, Nugent M, Simpson P, Kovacic K. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1987-1994.e2. doi: 10.1016/j.cgh.2019.10.012. Epub 2019 Oct 14.
PubMed 31622740
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome: A Randomized, Double-Blind, Sham-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04428619
- Acronym / sponsor ID
- IRB# 19-001796
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Innovative Health Solutions
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral Electrical Nerve Field Stimulation (PENFS) Device | Active comparator | Device: Peripheral Electrical Nerve Field Stimulation (PENFS) DeviceThe PENFS device has a battery activated generator and wire harness. Four leads are attached to the generator, each with a sterile 2 mm, titanium needle. The patient's ear is trans-illuminated to identify neurovascular bundles that are avoided during needle placement. The generator is attached with adhesive to the skin behind the patient's ear. Needles are inserted into the dorsal and ventral aspects of the ear, within 1-1.5 mm of the vascular branches to create a field effect. The device settings are standardized and deliver 3.2 volts with alternating frequencies (1 ms pulses of 1 Hz and 10 Hz) every 2 s. This stimulation targets central pain pathways through branches of cranial nerves V, VII, IX, and X, which innervate the external ear. The device is worn for 5 days/week for a total of 4 weeks. Patients remove devices at home on day 6 of each treatment cycle. Patients will be asked to wear a SmartWatch during the study to monitor heart rate. |
| Sham Device | Sham comparator | Device: Sham DeviceThe sham devices will be identical to the active devices but will not administer electrical charges. Per manufacturer design and patient anecdotal experience from previous studies, both active stimulation and sham are below detectable sensation threshold. Per report from previous studies, some patients may experience a sensation around the ear after percutaneous needle placement; however, this sensation can occur with equal likelihood in the active or sham device. The device is worn for 5 days a week for a total of 4 weeks. Patients remove devices at home on day 6 of each treatment cycle. Patients will also be asked to wear a SmartWatch as above. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Electrical Nerve Field Stimulation (PENFS) DevicePatients 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). | Device | Peripheral Electrical Nerve Field Stimulation (PENFS) Device |
| Sham DevicePatients 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). | Device | Sham Device |
Primary outcome
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.
13 secondary outcomes
Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 4 Weeks.
Time frame: 4 weeks
IBS Symptom Severity Responder Rate
Time frame: Week 4
Mean Change in Average Daily Worst Abdominal Pain From Baseline
Time frame: Week 4
Change in Average Daily Stool Consistency From Baseline
Time frame: Week 4
Change in Average Weekly Bowel Habits From Baseline
Time frame: Week 4, week 8
Change in Quality of Life From Baseline
Time frame: Week 4, week 8
"Number of Participants With Treatment-related Adverse Events as Assessed by a Weekly Adverse Events Questionnaire
Time frame: Week 4
Change in Average Weekly Bloating Symptoms From Baseline
Time frame: 4 weeks, 8 weeks
Change in Average Weekly Abdominal Pain Symptoms From Baseline
Time frame: 4 weeks, 8 weeks
Chang in Average Weekly Bowel Habits From Baseline
Time frame: 4 weeks, 8 weeks
Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at Baseline.
Time frame: Baseline
Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at Baseline.
Time frame: Baseline
Mean and Standard Deviation of Heart Rate Variability (HRV) Measures in PENFS Device and Sham Groups at 4 Weeks.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28826627Kovacic K, Hainsworth K, Sood M, Chelimsky G, Unteutsch R, Nugent M, Simpson P, Miranda A. Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):727-737. doi: 10.1016/S2468-1253(17)30253-4. Epub 2017 Aug 18.
- Background: PubMed 31622740Krasaelap A, Sood MR, Li BUK, Unteutsch R, Yan K, Nugent M, Simpson P, Kovacic K. Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1987-1994.e2. doi: 10.1016/j.cgh.2019.10.012. Epub 2019 Oct 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Chang, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Electrical Nerve Field Stimulation (PENFS) Device in people with Irritable Bowel Syndrome and Abdominal Pain, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in IBS Symptom Severity From Baseline (time frame: 4 weeks, 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04428619, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.