Microelectrode Recordings From the Vagus Nerve in Awake Humans

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Other Locations
Australia
99 Commercial Road
RECRUITING
Prahan Victoria
Contact Information
Primary
Kathryn Vera, PhD
giero002@umn.edu
612-625-5018
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 60
Treatments
Experimental: VNS
participants with surgically implanted VNS electrodes to treat drug-resistant epilepsy
Experimental: non-VNS participants
participants without implanted VNS devices
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov