Vagal nerve stimulation for treating irritable bowel syndrome

Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the Potential Predictive Role for the Vagal-Autonomic Neurosignature

This study tests if a new device that stimulates a nerve in the ear can help people with irritable bowel syndrome feel better after 8 weeks of treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Maastricht University Medical Center (Academic / other)
• Locations: 1 site (Maastricht, Limburg)
• Trial ID: NCT06090110 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of transcutaneous auricular vagal nerve stimulation (tVNS) on patients with irritable bowel syndrome (IBS). Participants will undergo 8 weeks of treatment with a vagal nerve stimulator, and their clinical response will be measured using the IBS-SSS questionnaire. The study also aims to determine if pre-treatment autonomic responses and brain imaging can predict treatment outcomes, as well as assess the impact on quality of life, depression, and anxiety. Participants will wear a Fitbit and complete daily questionnaires for one week, followed by a functional brain MRI.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of IBS according to Rome IV criteria.

Not a fit: Patients with a history of abdominal surgery or those with certain metallic implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients suffering from irritable bowel syndrome.

How similar studies have performed: While the approach of using vagal nerve stimulation is being explored, this specific application in IBS is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* A diagnosis of IBS according to Rome IV criteria (3), as follows:
* Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria:
* Related to defecation.
* Associated with a change in stool frequency.
* Associated with a change in stool from (appearance).
* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
* Age between 18 and 75 years;
* Ability to understand and speak the Dutch language.
* Ability to understand how to utilize the ESM application.

Exclusion Criteria:

* A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present or otherwise based on the principal investigator's judgement.
* Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device (with the exception of the Mirena IUD), metal braces, facial tattoos and/or metal objects.
* History of major head trauma or head/brain surgery
* History of claustrophobia
* Pregnancy, lactation, intention to become pregnant during the study period
* Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional or hierarchical position with regards to any of the study team members or their department.
* If the subject has a cardiac arrhythmia, the attending physician will be consulted before participation.

Where this trial is running

Maastricht, Limburg

• Maastricht University — Maastricht, Limburg, Netherlands (Recruiting)

Study contacts

• Principal investigator: Daniel Keszthelyi — Maastricht University
• Study coordinator: Kimberly Hawinkels

Conditions Irritable Bowel Syndrome; vagal nerve stimulation