Microelectrode Recordings From the Vagus Nerve in Awake Humans
Recruiting · NCT06016686 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Minnesota
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- University of Minnesota - Minneapolis, Minnesota, United States