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NCT Number: NCT06090110

Vagal Nerve Stimulation in Irritable Bowel Syndrome

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location status: Recruiting

Location contact

Kimberly Hawinkels

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vagal nerve stimulation

Device

Transcutaneous Auricular Vagal Nerve Stimulation

Sham stimulation

Device

Sham stimulation with a non-conduction electrode

Primary outcomes

  1. Clinical meaningful decrease in severity of GI-symptoms

    Time frame: at the end of the 8 week treatment period

    Measuring IBS-SSS, defined as a decrease of at least 50 points

Secondary outcomes

  1. Predictive value of neuro-signature

    Time frame: 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.

  2. adverse events

    Time frame: at the end of the 8 week treatment period

    Number and severity of adverse events

  3. Anxiety/depression

    Time frame: at the end of the 8 week treatment period

    Symptoms of anxiety and depression measured using PHQ-9 and GAD-7

  4. Cost-effectiveness

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

    Direct and indirect costs made during the treatment period

  5. Time the device was used

    Time frame: at the end of the 8 week treatment period

    The amount of time patients used the tVNS device

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Hawinkels

CONTACT

[email protected]

0883887808

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the Potential Predictive Role for the Vagal-Autonomic Neurosignature

Acronym: RESILIENCE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 19, 2023
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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