CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Peripheral Electrical Nerve Field Stimulation (PENFS) Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04428619
NCT04428619N/ACompleted
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Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With Irritable Bowel Syndrome: A Randomized, Double-Blind, Sham-Controlled Pilot Study

University of California, Los Angeles·interventional·Posted Jun 11, 2020·Updated May 16, 2025

In Brief

A clinical study evaluating Peripheral Electrical Nerve Field Stimulation (PENFS) Device and Sham Device for Irritable Bowel Syndrome and 2 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome, Abdominal Pain, Autonomic Nervous System Imbalance
CountriesUnited States
CollaboratorsInnovative Health Solutions

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 11, 2020
Enrollment StartAug 1, 2020
Primary CompletionFeb 14, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.1 years ago

Interventions

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).