RECRUITING

Microelectrode Recordings From the Vagus Nerve in Awake Humans

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Microelectrode Recordings From the Vagus Nerve in Awake Humans

Quick Facts

Study Start:2024-04-01
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06016686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * The participant is greater than or equal to (≥)18 years and is less than or equal to (≤) 40 years of age
  2. * English speaking
  3. * Medicare covered or equivalent health insurance from a partner country
  1. * Pregnant
  2. * Smokes and is unwilling to abstain from smoking on the day of the experiment.
  3. * Inability or unwillingness to provide written informed consent.
  4. * Individuals with difficulty standing unassisted for 5 minutes during the tilt-table testing
  5. * 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
  6. * Vagus nerve not visible on ultrasound
  7. * VNS electrodes are not in a suitable location to allow for microelectrode insertion
  8. * Any other clinical reasons deemed by the investigators

Contacts and Locations

Study Contact

Kathryn Vera, PhD
CONTACT
612-625-5018
giero002@umn.edu

Principal Investigator

Vaughan G Macefield, PhD
PRINCIPAL_INVESTIGATOR
Monash University
John Osborn
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Vaughan G Macefield, PhD, PRINCIPAL_INVESTIGATOR, Monash University
  • John Osborn, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Epilepsy