Loading clinical trials...

Neural Correlates of tVNS | Clinical Trials | Clareo Health

UNKNOWN

Neural Correlates of tVNS

Functional Neural Correlates of Transcutaneous Vagal Nerve Stimulation: Effects of Anatomical Site and Waveform Parameters - An Exploratory High Resolution fMRI Study in Healthy Volunteers

NCT04810234•Maastricht University Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

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
+6 more criteria

Locations (2)

Maastricht University Medical Center

Maastricht, Netherlands

Queen Mary University of London. Wingate Institute of Neurogastroenterology

London, United Kingdom

Key Dates

Start Date

November 1, 2020

Primary Completion Date

June 1, 2021

Completion Date

June 1, 2021

Last Updated

March 22, 2021

Enrollment

ESTIMATED participants

Conditions

fMRITranscutaneous Vagal Nerve Stimulation (tVNS)Nucleus of the Solitary Tract (NTS)

Interventions

transcutaneous vagal nerve stimulation (tVNS)

DEVICE

Contacts

Abraham Beckers, MD

CONTACT

+31433881844 ab.beckers@maastrichtuniversity.nl

Top-Down Attentional Control of Visual-Processing

NCT01087281

Focal Brain LesionFocal Lesions+1 more

View study

RECRUITINGNA

Study of Functional Magnetic Resonance Signal Variations in Patients Undergoing Anterior Cruciate Ligament Reconstruction With the Application of a Dedicated Neuromotor Training

NCT07097077

fMRIACL Injury+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Neural Correlates of tVNS

Inclusion Criteria

Exclusion Criteria

Top-Down Attentional Control of Visual-Processing

Study of Functional Magnetic Resonance Signal Variations in Patients Undergoing Anterior Cruciate Ligament Reconstruction With the Application of a Dedicated Neuromotor Training

Clinical Classification and Imaging Markers in Patients of Obesity

7.0T Magnetic Resonance Imaging Study for Hepatic Encephalopathy

Personalized Dual-target RTMS for Patients with Refractory Schizophrenia

Simultaneously PET/MRI in Prolonged DOC Patients