NCT06016686 Microelectrode Recordings From the Vagus Nerve in Awake Humans
| NCT ID | NCT06016686 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Minnesota |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Vaughan G Macefield, PhD
PRINCIPAL INVESTIGATOR
Monash University
Frequently Asked Questions
Who can join the NCT06016686 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06016686 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06016686 currently recruiting?
Yes, NCT06016686 is actively recruiting participants. Contact the research team at giero002@umn.edu for enrollment information.
Where is the NCT06016686 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06016686 clinical trial?
NCT06016686 is sponsored by University of Minnesota. The principal investigator is Vaughan G Macefield, PhD at Monash University. The trial plans to enroll 60 participants.
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