NCT06090110

Vagal Nerve Stimulation in 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	Vagal Nerve Stimulation	Transcutaneous Auricular Vagal Nerve Stimulation
DEVICE	Sham stimulation	Sham stimulation with a non-conduction electrode

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2023-10-19
• Last updated: 2024-08-02

Locations

1 site across 1 country: Netherlands