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 range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood oxygenation level dependent BOLD signal activity in the NTS

Timeframe: During fMRI

Trial details

NCT IDNCT06659172

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-03

View on ClinicalTrials.gov More Healthy Females trials