Maastricht University
Maastricht, Limburg, 6229ER, Netherlands
Location status: Recruiting
NCT Number: NCT06090110
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 6229ER, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transcutaneous Auricular Vagal Nerve Stimulation
Sham stimulation with a non-conduction electrode
Time frame: at the end of the 8 week treatment period
Measuring IBS-SSS, defined as a decrease of at least 50 points
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.
Time frame: at the end of the 8 week treatment period
Number and severity of adverse events
Time frame: at the end of the 8 week treatment period
Symptoms of anxiety and depression measured using PHQ-9 and GAD-7
Time frame: at follow up moment 2 (6 months after 8 week treatment period)
Direct and indirect costs made during the treatment period
Time frame: at the end of the 8 week treatment period
The amount of time patients used the tVNS device
Contact information is provided by the study sponsor or research team.
Maastricht University Medical Center
Other
Clinical Efficacy of Transcutaneous Auricular Vagal Nerve Stimulation in Irritable Bowel Syndrome and the Potential Predictive Role for the Vagal-Autonomic Neurosignature
Acronym: RESILIENCE
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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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