Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the potential predictive role for the Vagal-Autonomic Neurosignature

Recruiting

• Conditions: IBS; irritable bowel syndroom; 10018012

• Registration Number: NL-OMON56386
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 166

Inclusion Criteria

- Patients with IBS according to Rome IV criteria
- Aged between 18-75 years
- Ability to understand and speak the Dutch language.
- Ability to understand how to utilize the ESM application.

Exclusion Criteria

- Any organic explanation for the abdominal symptoms;
- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A clinically meaningful decrease in severity of GI-symptoms after the 8-week<br /><br>treatment period, measured using the IBS-SSS defined as a decrease of >= 50<br /><br>points. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The relation between brain activation profiles including patterns predicted<br /><br>by the ESM tool in combination with the wearable.<br /><br>- The value of the multimodal neuro-signature in the prediction of clinical<br /><br>response to tVNS in IBS-patients.<br /><br>- Number and severity of adverse events<br /><br>- Symptoms of anxiety and depression<br /><br>- Direct and indirect costs made during the treatment period<br /><br>- Satisfaction with the treatment<br /><br>- The amount of time patients used the tVNS device<br /><br>- The comparison of microbiota before and after treatmen</p><br>