Status:
UNKNOWN
Neural Correlates of tVNS
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Wingate Institute of Neurogastroenterology
Conditions:
fMRI
Transcutaneous Vagal Nerve Stimulation (tVNS)
Eligibility:
FEMALE
18-40 years
Brief Summary
Transcutaneous vagal nerve stimulation (tVNS) has been applied to a number of disease areas including visceral pain, depression, cluster headache and Alzheimer's disease. However, there is marked hete...
Eligibility Criteria
Inclusion
- 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;
- Women on oral contraceptives only
- All subjects should be right-handed.
- Inclusion will be determined on the basis of availability. Subjects should be able to attend for 2 scanning sessions.
- Exclusion criteria
- 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, 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
Exclusion
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04810234
Start Date
November 1 2020
End Date
June 1 2021
Last Update
March 22 2021
Active Locations (2)
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1
Maastricht University Medical Center
Maastricht, Netherlands, 6229 ER
2
Queen Mary University of London. Wingate Institute of Neurogastroenterology
London, United Kingdom