Status:
RECRUITING
Vagal Nerve Stimulation in Irritable Bowel Syndrome
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT06090110
Start Date
December 1 2023
End Date
November 1 2026
Last Update
August 2 2024
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands, 6229ER