Vagal Nerve Stimulation in Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Device: Sham stimulationDevice: Vagal Nerve Stimulation
- Registration Number
- NCT06090110
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 166
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Sham stimulation sham stimulation with a non-conducting electrode, for 8 weeks at least one hour a day Intervention Vagal Nerve Stimulation transcutaneous auricular vagal nerve stimulation, for 8 weeks at least one hour a day
- Primary Outcome Measures
Name Time Method Clinical meaningful decrease in severity of GI-symptoms at the end of the 8 week treatment period Measuring IBS-SSS, defined as a decrease of at least 50 points
- Secondary Outcome Measures
Name Time Method Anxiety/depression at the end of the 8 week treatment period Symptoms of anxiety and depression measured using PHQ-9 and GAD-7
Cost-effectiveness at follow up moment 2 (6 months after 8 week treatment period) Direct and indirect costs made during the treatment period
adverse events at the end of the 8 week treatment period Number and severity of adverse events
Predictive value of neuro-signature at the end of the 8 week treatment period The value of the multimodal neuro-signature in the prediction of clinical response to tVNS in IBS-patients.
Time the device was used at the end of the 8 week treatment period The amount of time patients used the tVNS device
Trial Locations
- Locations (1)
Maastricht University
🇳🇱Maastricht, Limburg, Netherlands