Vagal Nerve Stimulation in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— RESILIENCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090110
• Other study ID #: NL84720.068.23
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: January 2024
• Source: Maastricht University Medical Center
• Contact: Kimberly Hawinkels
• Phone: 0883887808
• Email: kimberly.hawinkels[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Device:
• Vagal Nerve Stimulation
Transcutaneous Auricular Vagal Nerve Stimulation
• Sham stimulation
Sham stimulation with a non-conduction electrode

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical meaningful decrease in severity of GI-symptoms	Measuring IBS-SSS, defined as a decrease of at least 50 points	at the end of the 8 week treatment period
Secondary	Predictive value of neuro-signature	The value of the multimodal neuro-signature in the prediction of clinical response to tVNS in IBS-patients.	at the end of the 8 week treatment period
Secondary	adverse events	Number and severity of adverse events	at the end of the 8 week treatment period
Secondary	Anxiety/depression	Symptoms of anxiety and depression measured using PHQ-9 and GAD-7	at the end of the 8 week treatment period
Secondary	Cost-effectiveness	Direct and indirect costs made during the treatment period	at follow up moment 2 (6 months after 8 week treatment period)
Secondary	Time the device was used	The amount of time patients used the tVNS device	at the end of the 8 week treatment period