The effect of Transcutaneous Vagal Nerve Stimulation on the processing of visceral pain signals: a High Resolution fMRI Study in Healthy Volunteers
- Conditions
- abdominal painVisceral pain10018012
- Registration Number
- NL-OMON56195
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
• 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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To explore the possible functional brain differences between taVNS vs sham in<br /><br>the duodenal capsaicin experimental pain model.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To explore the degree of activation of the Cingulate Cortex, Insula,<br /><br>Thalamus, Prefrontal cortex, the Primary and Secondary Somatosensory Cortex,<br /><br>the Amygdala, Periaqueductal grey and possibly cerebellar structures as a<br /><br>result of taVNS, compared to sham stimulation, in the capsaicin-pain model;<br /><br>2. To assess the correlation between fMRI findings and Visual Analogue Scores<br /><br>(VAS) for pain;<br /><br>3. To assess the effect of taVNS vs sham on pulse rate variability, as a<br /><br>measure of vagal tone of the autonomous nervous system.</p><br>