Actively Recruiting
Vagal Nerve Stimulation in Irritable Bowel Syndrome
Led by Maastricht University Medical Center · Updated on 2024-08-02
166
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vagal Nerve Stimulation in Irritable Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with irritable bowel syndrome (IBS) according to Rome IV criteria
- Recurrent abdominal pain at least 1 day per week in the last 3 months, related to defecation and changes in stool frequency or appearance
- Symptoms present for at least 6 months prior to diagnosis
- Age between 18 and 75 years
- Able to understand and speak Dutch
- Able to use the Experience Sampling Method (ESM) application
You will not qualify if you...
- History of abdominal surgery except uncomplicated appendectomy, laparoscopic cholecystectomy, or hysterectomy
- Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, or most metal objects
- History of major head trauma or brain surgery
- History of claustrophobia
- Pregnancy, lactation, or intention to become pregnant during the study
- Students or employees of Maastricht University with direct personal or professional ties to the study team
- Cardiac arrhythmia without physician approval before participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maastricht University
Maastricht, Limburg, Netherlands, 6229ER
Actively Recruiting
Research Team
K
Kimberly Hawinkels
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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