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NCT06016686Not yet recruiting

Microelectrode Recordings From the Vagus Nerve in Awake Humans

University of MinnesotaPhase 1ClinicalTrials.govother
Study focus
Disease/Condition
Epilepsy
Drug/Device/Intervention
VNS stimulation and intraneural recordings
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
University of Minnesota
Location
Minneapolis,Prahan Victoria, Australia,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Oct 01, 2023
End date
Oct 01, 2024
Enrollment
60 participants
Primary outcome

identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS),identify ratio of myelinated fibers in specific fibers activated by vagal nerve stimulation (VNS),physiological identification of the specific fibers activated by vagal nerve stimulation (VNS),identify firing rates of the specific fibers activated by vagal nerve stimulation (VNS),identify stimulus current required to activate specific fibers activated by vagal nerve stimulation (VNS),differences in firing rates of cardiac parasympathetic vagal activity,Discharge variability of cardiac parasympathetic nerve fibers

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.

ICD-10 classifications
EpilepsyEpilepsy, unspecifiedOther epilepsyStatus epilepticusOther status epilepticus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06016686
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06016686 through Pure Global AI's free database. This Phase 1 trial is sponsored by University of Minnesota and is currently Not yet recruiting. The study focuses on Epilepsy. Target enrollment is 60 participants.

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