Recording nerve activity from the vagus nerve in awake individuals
Microelectrode Recordings From the Vagus Nerve in Awake Humans
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06016686 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking individuals aged 18 to 40 with Medicare or equivalent health insurance.
Not a fit: Patients who are pregnant, smoke and cannot abstain, or have significant carotid artery issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved VNS therapies for epilepsy and other conditions.
How similar studies have performed: Previous studies using similar techniques have been conducted safely, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Minneapolis, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.