Clinical trial NCT06016686: Microelectrode Recordings From the Vagus Nerve in Awake Humans
Official title: Microelectrode Recordings From the Vagus Nerve in Awake Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* The participant is greater than or equal to (≥)18 years and is less than or equal to (≤) 40 years of age
* English speaking
* Medicare covered or equivalent health insurance from a partner country

Exclusion Criteria:

* Pregnant
* Smokes and is unwilling to abstain from smoking on the day of the experiment.
* Inability or unwillingness to provide written informed consent.
* Individuals with difficulty standing unassisted for 5 minutes during the tilt-table testing
* Individuals found to have a significant carotid artery plaque or intima-media thickness \> 1 mm as assessed by ultrasonography during the ultrasound-screening steps of the study visit
* Vagus nerve not visible on ultrasound
* VNS electrodes are not in a suitable location to allow for microelectrode insertion
* Any other clinical reasons deemed by the investigators

Primary outcomes:
measure: identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS)
timeFrame: 4 hours
measure: identify ratio of myelinated fibers in specific fibers activated by vagal nerve stimulation (VNS)
timeFrame: 4 hours
measure: physiological identification of the specific fibers activated by vagal nerve stimulation (VNS)
timeFrame: 4 hours
measure: identify firing rates of the specific fibers activated by vagal nerve stimulation (VNS)
timeFrame: 4 hours
measure: identify stimulus current required to activate specific fibers activated by vagal nerve stimulation (VNS)
timeFrame: 4 hours
measure: differences in firing rates of cardiac parasympathetic vagal activity
timeFrame: 4 hours
measure: Discharge variability of cardiac parasympathetic nerve fibers
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Prahan Victoria
country: Australia
facility: 99 Commercial Road
Study officials:
affiliation: Monash University
name: Vaughan G Macefield, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: John Osborn
role: PRINCIPAL_INVESTIGATOR
References: