Vagal Nerve Stimulation in Irritable Bowel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vagal Nerve Stimulation, Sham stimulation.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the Potential Predictive Role for the Vagal-Autonomic Neurosignature
Overview
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.
Interventions
- Device Vagal Nerve Stimulation
Transcutaneous Auricular Vagal Nerve Stimulation - Device Sham stimulation
Sham stimulation with a non-conduction electrode
Primary outcome measures
- Clinical meaningful decrease in severity of GI-symptoms [Time frame: at the end of the 8 week treatment period]
Secondary outcome measures (5)
- Predictive value of neuro-signature [Time frame: at the end of the 8 week treatment period]
- adverse events [Time frame: at the end of the 8 week treatment period]
- Anxiety/depression [Time frame: at the end of the 8 week treatment period]
- Cost-effectiveness [Time frame: at follow up moment 2 (6 months after 8 week treatment period)]
- Time the device was used [Time frame: at the end of the 8 week treatment period]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Maastricht University — Maastricht
Identifiers
NCT: NCT06090110 · NL84720.068.23