Vagal Nerve Stimulation in Irritable Bowel Syndrome (RESILIENCE)

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Irritable Bowel Syndrome

Treatments: Device: Sham stimulation; Device: Vagal Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06090110

NL84720.068.23

Details and patient eligibility

About

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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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166 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

transcutaneous auricular vagal nerve stimulation, for 8 weeks at least one hour a day

Treatment:

Device: Vagal Nerve Stimulation

placebo

Placebo Comparator group

Description:

sham stimulation with a non-conducting electrode, for 8 weeks at least one hour a day

Treatment:

Device: Sham stimulation