Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06016686

Microelectrode Recordings From the Vagus Nerve in Awake Humans

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Kathryn Vera, PhD

CONTACT

[email protected]

612-625-5018

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS)

    Time frame: 4 hours

    assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module

  2. identify ratio of myelinated fibers in specific fibers activated by vagal nerve stimulation (VNS)

    Time frame: 4 hours

    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.

  3. physiological identification of the specific fibers activated by vagal nerve stimulation (VNS)

    Time frame: 4 hours

    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. identify firing rates of the specific fibers activated by vagal nerve stimulation (VNS)

    Time frame: 4 hours

    assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. in Hertz

  5. identify stimulus current required to activate specific fibers activated by vagal nerve stimulation (VNS)

    Time frame: 4 hours

    assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. in milli-amps

  6. differences in firing rates of cardiac parasympathetic vagal activity

    Time frame: 4 hours

    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.

  7. Discharge variability of cardiac parasympathetic nerve fibers

    Time frame: 4 hours

    Vagal nerve stimulator device. Coefficient of variation, %

Study contacts

Contact information is provided by the study sponsor or research team.

Kathryn Vera, PhD

CONTACT

[email protected]

612-625-5018

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.