Active — Not RecruitingNot Applicable

Neuromodulation With Percutaneous Electrical Nerve Field Stimulation

United States140 participantsStarted 2026-01-08

Plain-language summary

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 Percutaneous electrical nerve field stimulation (PENFS) in adults with gastroparesis like symptoms (GPLS) is not currently known. This study is a double-blind, randomized, sham-controlled pilot study evaluating the efficacy of PENFS using IB-Stim in adult patients with GPLS. A secondary aim will be to assess whether treatment with PENFS is associated with changes in autonomic function via heart rate variability.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ability to provide written, informed consent * Patients who meet Rome IV criteria for Functional Dyspepsia (FD), with or without a delay in gastric emptying: * One or more of the following: Bothersome postprandial fullness, Bothersome early satiation, Bothersome epigastric pain, Bothersome epigastric burning * No evidence of structural disease that is likely to explain the symptoms * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis * Average daily worst abdominal pain score between 4 and 8 (on a 0-10-point rating scale) during the screening period. A minimum reporting of abdominal pain will be required for 5/7 days in the baseline period. * Minimum of 2 days of abdominal pain/week prior to starting trial. * At least moderate symptom severity with a GCSI score of at least 2.0 during screening * If receiving pharmacologic therapy for abdominal pain associated with GPLS, doses must be stable for at least 60 days prior to randomization. * If receiving pharmacologic therapy for GPLS that does not have an effect on abdominal pain, doses must be stable for at least 30 days prior to randomization. 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, c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in abdominal pain scores (on a 0-10 point rating scale, where 10 is the worst) from Baseline to Week 4

Timeframe: From Baseline through Week 4

Trial details

NCT IDNCT07492108

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Gastroparesis Like Symptoms trials