Ear device may calm stomach pain without drugs
NCT ID NCT07492108
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a small device worn behind the ear, which sends mild electrical pulses to nerves, can reduce abdominal pain in adults with gastroparesis-like symptoms (slow stomach emptying). About 140 participants will be randomly assigned to receive either the active device or a sham (fake) device for 4 weeks. The main goal is to see if the active device lowers pain scores more than the sham.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IB-Stim device (percutaneous electrical nerve field stimulation)
- What this could lead to
- If it works, this could offer a drug-free option to ease abdominal pain in people with gastroparesis-like symptoms.
- What could go wrong
- This is a small, early pilot study. The device may not reduce pain more than a sham (fake) treatment, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, celiac disease, diverticulitis, appendicitis, colorectal cancer, endometriosis, pregnancy, other intestinal or extra-intestinal malignancies. Patients with overlapping functional GI disorders (i.e. IBS) will not be excluded as long as GPLS is their predominant disorder * Patients prescribed GLP-1s * History of surgery involving Cranial Nerves V, VII, IX, or X. * History of abdominal surgeries other than appendectomy or cholecystectomy at least 6 months before the screening visit. * Patients with chronic opioid, benzodiazepine, or illicit substance use within the last 6 months. * Patients with underlying neurologic conditions, including history of: seizures, CVA, uncontrolled migraines, traumatic brain injury, multiple sclerosis * Patients with severe, uncontrolled psychiatric conditions, including severe major depression, psychosis, dissociative episodes, etc. * 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 known to be pregnant or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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