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| ID | Type | Description | Link |
|---|---|---|---|
| METC183019 | Other Identifier | METC aZM/UM |
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| Name | Class |
|---|---|
| Wingate Institute of Neurogastroenterology | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous vagal nerve stimulation (tVNS) | Device | Cervical and auricular transcutaneous stimulation of the vagus nerve |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | fMRI related outcome measure | 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) |
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Inclusion criteria:
Exclusion criteria
Females only (in order to limit confounding)
Female healthy volunteers aged between 18-40 years
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abraham Beckers, MD | Contact | +31433881844 | ab.beckers@maastrichtuniversity.nl |
| Name | Affiliation | Role |
|---|---|---|
| Ad Masclee, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Recruiting | Maastricht | 6229 ER | Netherlands |
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fMRI related outcome measure |
| 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) | fMRI related outcome measure | 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) | fMRI related outcome measure | 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) | fMRI related outcome measure | During stimulation (difference between stim on - stim off blocks) |
| Functional connectivity / Network Connectivity of CAN regions during "active tVNS" block [to all 5 points as identified above] | fMRI related outcome measure | During stimulation (difference between stim on - stim off blocks) |
| Queen Mary University of London. Wingate Institute of Neurogastroenterology | Active, not recruiting | London | United Kingdom |