Irritable Bowel SyndromeRESILIENCENCT06090110
Vagal Nerve Stimulation in Irritable Bowel Syndrome
A study testing Vagal Nerve Stimulation in people with Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2023to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Age between 18 and 75 years;
- Ability to understand and speak the Dutch language.
- Ability to understand how to utilize the ESM application.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht, Limburg, 6229ER
Kimberly Hawinkels, kimberly.hawinkels@maastrichtuniversity.nl
About this study
Official title: Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the Potential Predictive Role for the Vagal-Autonomic Neurosignature
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.
Read more
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
- Being tested
- Vagal Nerve Stimulation, Sham stimulation
- Keywords
- vagal nerve stimulation
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal Nerve StimulationDevice
Transcutaneous Auricular Vagal Nerve Stimulation
Sham stimulationDevice
Sham stimulation with a non-conduction electrode
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | transcutaneous auricular vagal nerve stimulation, for 8 weeks at least one hour a day Receives: Device: Vagal Nerve Stimulation |
| placebo | Placebo comparator | sham stimulation with a non-conducting electrode, for 8 weeks at least one hour a day Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical meaningful decrease in severity of GI-symptoms
Measuring IBS-SSS, defined as a decrease of at least 50 points
Measured: at the end of the 8 week treatment period
Secondary outcomes (5)
Predictive value of neuro-signature
The value of the multimodal neuro-signature in the prediction of clinical response to tVNS in IBS-patients.
Measured: at the end of the 8 week treatment period
adverse events
Number and severity of adverse events
Measured: at the end of the 8 week treatment period
Anxiety/depression
Symptoms of anxiety and depression measured using PHQ-9 and GAD-7
Measured: at the end of the 8 week treatment period
Cost-effectiveness
Direct and indirect costs made during the treatment period
Measured: at follow up moment 2 (6 months after 8 week treatment period)
Time the device was used
The amount of time patients used the tVNS device
Measured: at the end of the 8 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Dec 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Keszthelyi, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090110
- Sponsor's protocol ID
- NL84720.068.23
- Acronym
- RESILIENCE
- Status last verified
- Aug 2024
- First submitted
- 3 Oct 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the Potential Predictive Role for the Vagal-Autonomic Neurosignature
- ClinicalTrials.gov ID
- NCT06090110
- Acronym / sponsor ID
- RESILIENCE / NL84720.068.23
- Conditions
- Irritable Bowel Syndrome
- Keywords
- vagal nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: Vagal Nerve Stimulationtranscutaneous auricular vagal nerve stimulation, for 8 weeks at least one hour a day |
| placebo | Placebo comparator | Device: Sham stimulationsham stimulation with a non-conducting electrode, for 8 weeks at least one hour a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagal Nerve StimulationTranscutaneous Auricular Vagal Nerve Stimulation | Device | Intervention |
| Sham stimulationSham stimulation with a non-conduction electrode | Device | placebo |
Primary outcome
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
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Keszthelyi principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal Nerve Stimulation in people with Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Hawinkels (0883887808, kimberly.hawinkels@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical meaningful decrease in severity of GI-symptoms (time frame: at the end of the 8 week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.