Neural Correlates of tVNS

NCT04810234 | Unknown DMC

• 2 other identifiers: 65751.068.2018METC183019
• Study Type: observational
• Target: 16
• Locations: 2 countries
• Sites: 2

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)

Outcome Measures

Primary Outcomes (1)

• Blood oxygenation level dependent (BOLD) signal activity in the CAN during tVNS

  fMRI related outcome measure

  During stimulation (difference between stim on - stim off blocks)

Secondary Outcomes (6)

• Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 1)

  During stimulation (difference between stim on - stim off blocks)

• Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS )(parameter set 1)

  During stimulation (difference between stim on - stim off blocks)

• Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during auricular tVNS (parameter set 2)

  During stimulation (difference between stim on - stim off blocks)

• Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during cervical tVNS (parameter set 2)

  During stimulation (difference between stim on - stim off blocks)

• Voxel-wise dependent BOLD signal activity in the NTS of the brainstem; somatosensory cortex; insular cortex; ACC, hypothalamus; thalamus and amygdala during subliminal auricular tVNS (parameter set 1)

  During stimulation (difference between stim on - stim off blocks)

Interventions

transcutaneous vagal nerve stimulation (tVNS) DEVICE

Cervical and auricular transcutaneous stimulation of the vagus nerve

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Females only (in order to limit confounding)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female healthy volunteers aged between 18-40 years

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Wingate Institute of Neurogastroenterology: collaborator

Study Sites (2)

Maastricht University Medical Center

Maastricht, 6229 ER, Netherlands

RECRUITING

Queen Mary University of London. Wingate Institute of Neurogastroenterology

London, United Kingdom

ACTIVE NOT RECRUITING

Study Officials

• Ad Masclee, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abraham Beckers, MD

CONTACT

+31433881844; ab.beckers@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: November 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

NL (1); GB (1)