Effects of tVNS on Visceral Pain (NCT06659172) | Clinical Trial Compass
CompletedNot Applicable
Effects of tVNS on Visceral Pain
Netherlands24 participantsStarted 2023-04-17
Plain-language summary
Transcutaneous auricular vagal nerve stimulation (taVNS) has shown promise in reducing chronic abdominal pain, such as in irritable bowel syndrome (IBS). This pain is thought to result from a disruption in gut-brain communication involving the vagus nerve. Using brain imaging, we developed a pain model involving capsaicin (the spicy component in red peppers) to study this interaction. This study aims to explore how taVNS affects this pain model in healthy volunteers.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Of female sex;
* Healthy participants (defined as those without a pre-existing medical comorbidity)
* Age between 18 and 40 years;
* BMI between 18 and 30 kg/m2;
* All subjects should use some form of contraception (for IUDs only Mirena is accepted)
* All subjects should be right-handed.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* 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 other metal objects;
* History of major head trauma or head/brain surgery;
* History of claustrophobia;
* History of severe or chronic cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, haematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol;
* Use of regular medication, including vitamin and iron supplementation, except oral contraceptives, within 14 days prior to start of the study;
* Pregnancy, lactation, wish to become pregnant;
* High alcohol consumption (\>15 alcoholic unit…
What they're measuring
1
Blood oxygenation level dependent BOLD signal activity in the NTS