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Vagal Nerve Stimulation in Irritable Bowel Syndrome (RESILIENCE)

Primary Purpose

Irritable Bowel Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Vagal Nerve Stimulation
Sham stimulation
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring vagal nerve stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical meaningful decrease in severity of GI-symptoms
Measuring IBS-SSS, defined as a decrease of at least 50 points

Secondary Outcome Measures

Predictive value of neuro-signature
The value of the multimodal neuro-signature in the prediction of clinical response to tVNS in IBS-patients.
adverse events
Number and severity of adverse events
Anxiety/depression
Symptoms of anxiety and depression measured using PHQ-9 and GAD-7
Cost-effectiveness
Direct and indirect costs made during the treatment period
Time the device was used
The amount of time patients used the tVNS device

Full Information

First Posted
October 3, 2023
Last Updated
October 16, 2023
Sponsor
Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT06090110
Brief Title
Vagal Nerve Stimulation in Irritable Bowel Syndrome
Acronym
RESILIENCE
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
vagal nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
transcutaneous auricular vagal nerve stimulation, for 8 weeks at least one hour a day
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
sham stimulation with a non-conducting electrode, for 8 weeks at least one hour a day
Intervention Type
Device
Intervention Name(s)
Vagal Nerve Stimulation
Intervention Description
Transcutaneous Auricular Vagal Nerve Stimulation
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
Sham stimulation with a non-conduction electrode
Primary Outcome Measure Information:
Title
Clinical meaningful decrease in severity of GI-symptoms
Description
Measuring IBS-SSS, defined as a decrease of at least 50 points
Time Frame
at the end of the 8 week treatment period
Secondary Outcome Measure Information:
Title
Predictive value of neuro-signature
Description
The value of the multimodal neuro-signature in the prediction of clinical response to tVNS in IBS-patients.
Time Frame
at the end of the 8 week treatment period
Title
adverse events
Description
Number and severity of adverse events
Time Frame
at the end of the 8 week treatment period
Title
Anxiety/depression
Description
Symptoms of anxiety and depression measured using PHQ-9 and GAD-7
Time Frame
at the end of the 8 week treatment period
Title
Cost-effectiveness
Description
Direct and indirect costs made during the treatment period
Time Frame
at follow up moment 2 (6 months after 8 week treatment period)
Title
Time the device was used
Description
The amount of time patients used the tVNS device
Time Frame
at the end of the 8 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6067EV
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Keszthelyi

12. IPD Sharing Statement

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Vagal Nerve Stimulation in Irritable Bowel Syndrome

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