Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the Potential Predictive Role for the Vagal-Autonomic Neurosignature

Maastricht University Medical Center1 site in 1 country166 target enrollmentDecember 1, 2023

ConditionsIrritable Bowel Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Irritable Bowel Syndrome
Sponsor: Maastricht University Medical Center
Enrollment: 166
Locations: 1
Primary Endpoint: Clinical meaningful decrease in severity of GI-symptoms
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

December 1, 2023

End Date

November 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Outcomes

Primary Outcomes

Clinical meaningful decrease in severity of GI-symptoms

Time Frame: at the end of the 8 week treatment period

Measuring IBS-SSS, defined as a decrease of at least 50 points

Secondary Outcomes

Anxiety/depression(at the end of the 8 week treatment period)
Cost-effectiveness(at follow up moment 2 (6 months after 8 week treatment period))
adverse events(at the end of the 8 week treatment period)
Predictive value of neuro-signature(at the end of the 8 week treatment period)
Time the device was used(at the end of the 8 week treatment period)