abdominal pain Visceral pain
Conditions
Interventions
Transcutaneous vagal nerve stimulation to the cymba concha of the right ear. As
a control condition, sham stimulation to the right earlobe will be used, this
area receives no vagal innervation. Infu
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion 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
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, 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 units consumed per week); • Using drugs of abuse; • Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study; • Participants unable to provide informed consent • Participants with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson*s disease) • Current smokers or current use of nicotine in any other way (including E-cigarettes and patches) • History of clinical anxiety or depression, or a hospital anxiety or depression score >8 • Participants whom score 8 or more on the HADS-questionnaire at study commencement • Patient whom have cardiovascular conduction problems • Patient with cochlear implants • Not meeting any of the inclusion criteria above • Any evidence of structural brain abnormalities examined by anatomical MRI will lead to exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To explore the possible functional brain differences between taVNS vs sham in the duodenal capsaicin experimental pain model. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To explore the degree of activation of the Cingulate Cortex, Insula, Thalamus, Prefrontal cortex, the Primary and Secondary Somatosensory Cortex, the Amygdala, Periaqueductal grey and possibly cerebellar structures as a result of taVNS, compared to sham stimulation, in the capsaicin-pain model; 2. To assess the correlation between fMRI findings and Visual Analogue Scores (VAS) for pain; 3. To assess the effect of taVNS vs sham on pulse rate variability, as a measure of vagal tone of the autonomous nervous system. | — |
Countries
Netherlands
Outcome results
None listed