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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | transcutaneous auricular vagal nerve stimulation, for 8 weeks at least one hour a day |
|
| placebo | Placebo Comparator | sham stimulation with a non-conducting electrode, for 8 weeks at least one hour a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagal Nerve Stimulation | Device | Transcutaneous Auricular Vagal Nerve Stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive value of neuro-signature | The value of the multimodal neuro-signature in the prediction of clinical response to tVNS in IBS-patients. | at the end of the 8 week treatment period |
| adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Hawinkels | Contact | 0883887808 | kimberly.hawinkels@maastrichtuniversity.nl |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Keszthelyi | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Recruiting | Maastricht | Limburg | 6229ER | Netherlands |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Sham stimulation |
| Device |
Sham stimulation with a non-conduction electrode |
|
Number and severity of adverse events
| at the end of the 8 week treatment period |
| Anxiety/depression | Symptoms of anxiety and depression measured using PHQ-9 and GAD-7 | at the end of the 8 week treatment period |
| Cost-effectiveness | Direct and indirect costs made during the treatment period | 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 | at the end of the 8 week treatment period |
| D004066 | Digestive System Diseases |