Recruiting
Phase 1

Vagus Nerve

Sponsor:

University of Minnesota

Code:

NCT06016686

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

VNS stimulation and intraneural recordings

Record multi-unit activity from intraneural sites

Study Details

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.

Conditions

Epilepsy

Study ID

NCT06016686

Start date

Apr 1, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: VNS

participants with surgically implanted VNS electrodes to treat drug-resistant epilepsy

experimental: non-VNS participants

participants without implanted VNS devices

Interventions

VNS stimulation and intraneural recordings

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

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 outcome measure

  • identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]
  • identify ratio of myelinated fibers in specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]
  • physiological identification of the specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]
  • identify firing rates of the specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]
  • identify stimulus current required to activate specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]
  • differences in firing rates of cardiac parasympathetic vagal activity [ Time Frame: 4 hours ]
  • Discharge variability of cardiac parasympathetic nerve fibers [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Kathryn Vera, PhD

612-625-5018giero002@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Kathryn Vera, PhD

612-625-5018giero002@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-04-20.