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This Anchillary project uses a refined technique of ultrasound-guided microneurography of the human cervical vagus nerve, an approach developed by Professor Vaughan Macefield and used safely to-date in 44 prior study participants.
The overall goal of this project is to build upon prior data obtained using this approach by undertaking a detailed neurophysiological investigation of the human vagus nerve and to identify the nerve fibers activated during vagal nerve stimulation (VNS) in participants with implanted VNS devices in response to different stimulation parameters. In addition to providing data in unprecedented detail into the physiology of the human vagus nerve, this project will investigate different stimulus intensities, durations and frequencies that differentially excite myelinated and unmyelinated nerve fibers. These results will inform the CSP and guide future development of novel neural interfaces for VNS for various clinical applications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNS | Experimental | participants with surgically implanted VNS electrodes to treat drug-resistant epilepsy |
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| non-VNS participants | Experimental | participants without implanted VNS devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNS stimulation and intraneural recordings | Other | A minimum of three stimulation frequencies (1, 10 and 30 Hz), each up to 60s in duration, will be delivered via the VNS device. Intraneural recordings proximal or distal to the VNS electrodes during delivery of VNS will be performed. Approximately two to five fascicles will be explored in each nerve. |
| Measure | Description | Time Frame |
|---|---|---|
| identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS) | assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module | 4 hours |
| identify ratio of myelinated fibers in specific fibers activated by vagal nerve stimulation (VNS) | assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. Whether a nerve fiber is (un)myelinated can be determined by visual inspection. Myelinated fibers typically produce "a positive-going narrow spike profile. | 4 hours |
| physiological identification of the specific fibers activated by vagal nerve stimulation (VNS) | assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. use of tracing and nerve recordings analysis to identify the types of nerves | 4 hours |
| identify firing rates of the specific fibers activated by vagal nerve stimulation (VNS) | assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. in Hertz | 4 hours |
| identify stimulus current required to activate specific fibers activated by vagal nerve stimulation (VNS) | assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. in milli-amps | 4 hours |
| differences in firing rates of cardiac parasympathetic vagal activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Vera, PhD | Contact | 612-625-5018 | giero002@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vaughan G Macefield, PhD | Monash University | Principal Investigator |
| John Osborn | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Record multi-unit activity from intraneural sites | Other | Perform a more detailed vagal nerve mapping study by recording from single nerve fibers, including those fibers supplying the heart, lungs, airways and other end-organs. The investigators shall perform functional mapping of the left and right vagus nerves, such as those with cardiac-related and/or respiratory-related neural activity. The research team will also record activity from other nearby fibers to map the differences in neurological behavior in fascicles that control the heart, lungs, airways and other systems. |
|
compare any changes in parasympathetic vagal activity with participants who have not been implanted with a vagal nerve stimulator (Non-VNS Participants).
Labchart; spike histogram module. Unit: Hz.
| 4 hours |
| Discharge variability of cardiac parasympathetic nerve fibers | Vagal nerve stimulator device. Coefficient of variation, % | 4 hours |