Neural Correlates of tVNS

NCT ID: NCT04810234

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-06-01

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 heterogeneity in these studies pertaining to i) the anatomical site of stimulation (neck, inner concha or tragus of ear), and ii) the waveform parameters of the stimulating impulse. This exploratory cross-sectional study will address these knowledge gaps by comparative functional neuroimaging of the neural correlates of tVNS with disparate anatomical sites and electrical waveform characteristics during rest in healthy participants.

Conditions

fMRI; Transcutaneous Vagal Nerve Stimulation (tVNS); Nucleus of the Solitary Tract (NTS)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

transcutaneous vagal nerve stimulation (tVNS)

Cervical and auricular transcutaneous stimulation of the vagus nerve

Intervention Type: DEVICE

Eligibility 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;
• 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.

• Any evidence of structural brain abnormalities examined by anatomical MRI will lead to exclusion

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wingate Institute of Neurogastroenterology

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ad Masclee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status: RECRUITING

Queen Mary University of London. Wingate Institute of Neurogastroenterology

London, , United Kingdom

Site Status: ACTIVE_NOT_RECRUITING

Countries

Netherlands; United Kingdom

Central Contacts

Abraham Beckers, MD

Role: CONTACT

ab.beckers@maastrichtuniversity.nl

+31433881844

Facility Contacts

A.B. Beckers, MD

Role: primary

ab.beckers@maastrichtuniversity.nl

0433881844

Other Identifiers

METC183019

Identifier Type: OTHER

Identifier Source: secondary_id

65751.068.2018

Identifier Type: -

Identifier Source: org_study_id