Vagal Nerve Stimulation in Irritable Bowel Syndrome - Trial NCT06090110

Timeline & Enrollment

Primary Outcome

Clinical meaningful decrease in severity of GI-symptoms

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.

ICD-10 Classifications