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NCT06016686 · ClinicalTrials.gov registry record · Phase 1
Microelectrode Recordings From the Vagus Nerve in Awake Humans
A Phase 1 study of Epilepsy, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 7
- Study locations
NCT06016686: Recruiting Phase 1 study of Epilepsy, sponsored by University of Minnesota.
NCT06016686 is a Phase 1 study of Epilepsy that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 60 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (94% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06016686, a Phase 1 study of Epilepsy, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module
Conditions Studied
Interventions
- OTHER VNS stimulation and intraneural recordings
- OTHER Record multi-unit activity from intraneural sites
Study Locations (7)
California
- Stanford University - Stanford
Minnesota
- University of Minnesota - Minneapolis
Missouri
- Washington University in St. Louis - St Louis
Nebraska
- Alivation Research, LLC - Lincoln
South Carolina
- Medical University of South Carolina - Charleston
Victoria
- Alfred Health - Melbourne
Other
- 99 Commercial Road - Prahan Victoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
What NCT06016686 shows while recruiting
NCT06016686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which VNS stimulation and intraneural recordings is the first listed.
NCT06016686 lists 7 locations in 7 states (California, Minnesota, Missouri).
Frequently Asked Questions
What is clinical trial NCT06016686 about?
NCT06016686 is a clinical study titled "Microelectrode Recordings From the Vagus Nerve in Awake Humans". 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 obtaine...
What is the current status of trial NCT06016686?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2024-04-01. Estimated completion is 2026-04-01.
What conditions does trial NCT06016686 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT06016686?
The interventions under investigation include: VNS stimulation and intraneural recordings (OTHER), Record multi-unit activity from intraneural sites (OTHER).
Who is sponsoring clinical trial NCT06016686?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06016686 being conducted?
This trial has 7 study locations across California, Minnesota, Missouri, Nebraska, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06016686's enrollment target sits among peer trials
60 78th of 160 higher than 78 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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