Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
166 participants
INTERVENTIONAL
2023-12-01
2026-11-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention
transcutaneous auricular vagal nerve stimulation, for 8 weeks at least one hour a day
Vagal Nerve Stimulation
Transcutaneous Auricular Vagal Nerve Stimulation
placebo
sham stimulation with a non-conducting electrode, for 8 weeks at least one hour a day
Sham stimulation
Sham stimulation with a non-conduction electrode
Interventions
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Vagal Nerve Stimulation
Transcutaneous Auricular Vagal Nerve Stimulation
Sham stimulation
Sham stimulation with a non-conduction electrode
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Daniel Keszthelyi
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Maastricht University
Maastricht, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL84720.068.23
Identifier Type: -
Identifier Source: org_study_id
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