Microelectrode Recordings From the Vagus Nerve in Awake Humans

University of Minnesota (UMN)

Status and phase: Enrolling; Phase 1

Conditions: Epilepsy

Treatments: Other: Record multi-unit activity from intraneural sites; Other: VNS stimulation and intraneural recordings

Study type: Interventional

Funder types: Other

Identifiers

NCT06016686

VNS

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

VNS

Experimental group

Description:

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

Treatment:

Other: VNS stimulation and intraneural recordings

non-VNS participants

Experimental group

Description:

participants without implanted VNS devices

Treatment:

Other: Record multi-unit activity from intraneural sites