IBS irritable bowel syndroom
Conditions
Interventions
Group 1 will receive tVNS treatment during 8 weeks, group 2 will be a sham
group with a non-conducting electrode.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients with IBS according to Rome IV criteria - Aged between 18-75 years - Ability to understand and speak the Dutch language. - Ability to understand how to utilize the ESM application.
Exclusion criteria
Exclusion criteria: - Any organic explanation for the abdominal symptoms; - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A clinically meaningful decrease in severity of GI-symptoms after the 8-week treatment period, measured using the IBS-SSS defined as a decrease of >= 50 points. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The relation between brain activation profiles including patterns predicted by the ESM tool in combination with the wearable. - The value of the multimodal neuro-signature in the prediction of clinical response to tVNS in IBS-patients. - Number and severity of adverse events - Symptoms of anxiety and depression - Direct and indirect costs made during the treatment period - Satisfaction with the treatment - The amount of time patients used the tVNS device - The comparison of microbiota before and after treatmen | — |
Countries
Netherlands
Contacts
Public ContactK.E. Hawinkels
Universiteit Maastricht
Outcome results
None listed