Vagal Nerve Stimulation in Irritable Bowel Syndrome

NCT06090110 | Recruiting

• 1 other identifier: NL84720.068.23
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

vagal nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Predictive value of neuro-signature

  at the end of the 8 week treatment period

• adverse events

  at the end of the 8 week treatment period

• Anxiety/depression

  at the end of the 8 week treatment period

• Cost-effectiveness

  at follow up moment 2 (6 months after 8 week treatment period)

• Time the device was used

  at the end of the 8 week treatment period

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Device: Vagal Nerve Stimulation

placebo

PLACEBO COMPARATOR

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

Device: Sham stimulation

Interventions

Vagal Nerve Stimulation DEVICE

Transcutaneous Auricular Vagal Nerve Stimulation

Intervention

Sham stimulation DEVICE

Sham stimulation with a non-conduction electrode

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Daniel Keszthelyi

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Hawinkels

CONTACT

0883887808; kimberly.hawinkels@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 19, 2023
• Study Start: December 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

NL (1)