Neural Correlates of tVNS

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

• Registration Number: NCT04810234
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-19
• Last Update Submitted: 2021-03-19
• Study First Posted: 2021-03-22
• Last Update Posted: 2021-03-22
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood oxygenation level dependent (BOLD) signal activity in the CAN during tVNS	During stimulation (difference between stim on - stim off blocks)	fMRI related outcome measure

Secondary Outcome Measures

Name	Time	Method
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)	fMRI related outcome measure
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)	fMRI related outcome measure
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)	fMRI related outcome measure
Functional connectivity / Network Connectivity of CAN regions during "active tVNS" block [to all 5 points as identified above]	During stimulation (difference between stim on - stim off blocks)	fMRI related outcome measure
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)	fMRI related outcome measure
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)	fMRI related outcome measure

Trial Locations

Locations (2)

Queen Mary University of London. Wingate Institute of Neurogastroenterology; 🇬🇧 London, United Kingdom

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands