NCT06090110 Vagal Nerve Stimulation in Irritable Bowel Syndrome
| NCT ID | NCT06090110 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 166 participants in total. It began in 2023-12-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized control trial aims to evaluate the effect of transcutaneous auricular vagal nerve stimulation in patients with irritable bowel syndrome. The intervention will be 8 weeks of treatment with a vagal nerve stimulator. The main objectives are: * To evaluate the clinical response, defined as a decrease of at least 50 points on the IBS-SSS questionnaire, of the treatment. * To ascertain whether the autonomic-vagal neurosignature, derived from pre-treatment registration of symptom profiles, autonomic responses and imaging of neuronal activity as a reaction to stress is able to predict therapeutic response to tVNS accurately. * To evaluate the effect of treatment on quality of life * To evaluate the effect of treatment on depression * To evaluate the effect of treatment on anxiety Participants will be asked to wear a wearable (Fitbit) and fill out a daily questionnaire for one week. Thereafter, a functional brain MRI will be performed. In the intervention group patients will receive transcutaneous nerve stimulation for 8-weeks at home. The comparison group will receive the same device but with a non-conducting electrode. Patients fill out weekly questionnaires during the treatment period and at follow-up moments 3 and 6 months after finishing the treatment period.
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.
Contact & Investigator
Daniel Keszthelyi
PRINCIPAL INVESTIGATOR
Maastricht University
Frequently Asked Questions
Who can join the NCT06090110 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06090110 currently recruiting?
Yes, NCT06090110 is actively recruiting participants. Contact the research team at kimberly.hawinkels@maastrichtuniversity.nl for enrollment information.
Where is the NCT06090110 trial being conducted?
This trial is being conducted at Maastricht, Netherlands.
Who is sponsoring the NCT06090110 clinical trial?
NCT06090110 is sponsored by Maastricht University Medical Center. The principal investigator is Daniel Keszthelyi at Maastricht University. The trial plans to enroll 166 participants.