Functional Neural Correlates of Transcutaneous Vagal Nerve Stimulation: Effects of Anatomical Site and Waveform Parameters * An exploratory High Resolution fMRI Study in Healthy Volunteers
- Conditions
- Chronische pijnsyndromenHyperalgesia / chronic pain
- Registration Number
- NL-OMON50574
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
* 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 be on oral contraceptives
* All subjects should be right-handed.
* Inclusion will be determined on the basis of availability. They should be
able to attend for 2 scanning sessions.
* Presence of metallic prostheses, pacemakers, metal clips on blood vessels,
metal parts in the eye, an intrauterine device, 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, hematological/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;
* Any evidence of structural brain abnormalities examined by anatomical MRI
will lead to exclusion
* 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
* Patient whom have cardiovascular conduction problems
* Patient with cochlear implants
* Not meeting any of the inclusion criteria above
* Participants whom score 8 or more on the HADS-questionnaire at study
commencement
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Blood oxygenation level dependent (BOLD) signal activity in the central<br /><br>autonomic network (CAN) during tVNS.</p><br>
- Secondary Outcome Measures
Name Time Method