Clinical trial NCT06090110: Vagal Nerve Stimulation in Irritable Bowel Syndrome
Official title: Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the Potential Predictive Role for the Vagal-Autonomic Neurosignature
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: vagal nerve stimulation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical meaningful decrease in severity of GI-symptoms
timeFrame: at the end of the 8 week treatment period
Secondary outcomes:
measure: Predictive value of neuro-signature
timeFrame: at the end of the 8 week treatment period
measure: adverse events
timeFrame: at the end of the 8 week treatment period
measure: Anxiety/depression
timeFrame: at the end of the 8 week treatment period
measure: Cost-effectiveness
timeFrame: at follow up moment 2 (6 months after 8 week treatment period)
measure: Time the device was used
timeFrame: at the end of the 8 week treatment period
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Daniel Keszthelyi
role: PRINCIPAL_INVESTIGATOR
References: