Recording nerve activity from the vagus nerve in awake individuals
Official title: Microelectrode Recordings From the Vagus Nerve in Awake Humans
Run by University of Minnesota · NCT06016686 · Data updated 2026-11-12
This study is testing how different settings of vagus nerve stimulation affect nerve activity in awake people who have VNS devices, to better understand how the nerve works.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT06016686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking individuals aged 18 to 40 with Medicare or equivalent health insurance.
✕Probably not a fit
Patients who are pregnant, smoke and cannot abstain, or have significant carotid artery issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project utilizes a refined technique of ultrasound-guided microneurography to investigate the human cervical vagus nerve in awake participants. The study aims to gather detailed neurophysiological data on the vagus nerve and identify which nerve fibers are activated during vagal nerve stimulation (VNS) in individuals with implanted VNS devices. By varying stimulation parameters such as intensity, duration, and frequency, the research seeks to differentiate the responses of myelinated and unmyelinated nerve fibers. The findings will contribute to the development of novel neural interfaces for VNS and enhance understanding of its clinical applications.
Why it matters
Potential benefit: If successful, this study could lead to improved VNS therapies for epilepsy and other conditions.
How similar studies have gone: Previous studies using similar techniques have been conducted safely, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Minnesota
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Vaughan G Macefield, PhD — Monash University
- Study coordinator: Kathryn Vera, PhD
- Email: giero002@umn.edu
- Phone: 612-625-5018
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.