Microelectrode Recordings From the Vagus Nerve in Awake Humans
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| ClinicalTrials.gov Identifier: NCT06016686 |
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Recruitment Status :
Recruiting
First Posted : August 30, 2023
Last Update Posted : May 3, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Other: VNS stimulation and intraneural recordings Other: Record multi-unit activity from intraneural sites | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Microelectrode Recordings From the Vagus Nerve in Awake Humans |
| Actual Study Start Date : | April 1, 2024 |
| Estimated Primary Completion Date : | April 1, 2025 |
| Estimated Study Completion Date : | April 1, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: VNS
participants with surgically implanted VNS electrodes to treat drug-resistant epilepsy
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Other: VNS stimulation and intraneural recordings
A minimum of three stimulation frequencies (1, 10 and 30 Hz), each up to 60s in duration, will be delivered via the VNS device. Intraneural recordings proximal or distal to the VNS electrodes during delivery of VNS will be performed. Approximately two to five fascicles will be explored in each nerve. |
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Experimental: non-VNS participants
participants without implanted VNS devices
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Other: Record multi-unit activity from intraneural sites
Perform a more detailed vagal nerve mapping study by recording from single nerve fibers, including those fibers supplying the heart, lungs, airways and other end-organs. The investigators shall perform functional mapping of the left and right vagus nerves, such as those with cardiac-related and/or respiratory-related neural activity. The research team will also record activity from other nearby fibers to map the differences in neurological behavior in fascicles that control the heart, lungs, airways and other systems. |
- identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module
- identify ratio of myelinated fibers in specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. Whether a nerve fiber is (un)myelinated can be determined by visual inspection. Myelinated fibers typically produce "a positive-going narrow spike profile.
- physiological identification of the specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. use of tracing and nerve recordings analysis to identify the types of nerves
- identify firing rates of the specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. in Hertz
- identify stimulus current required to activate specific fibers activated by vagal nerve stimulation (VNS) [ Time Frame: 4 hours ]assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. in milli-amps
- differences in firing rates of cardiac parasympathetic vagal activity [ Time Frame: 4 hours ]
compare any changes in parasympathetic vagal activity with participants who have not been implanted with a vagal nerve stimulator (Non-VNS Participants).
Labchart; spike histogram module. Unit: Hz.
- Discharge variability of cardiac parasympathetic nerve fibers [ Time Frame: 4 hours ]Vagal nerve stimulator device. Coefficient of variation, %
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016686
| Contact: Kathryn Vera, PhD | 612-625-5018 | giero002@umn.edu |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Kathryn Vera, PhD 612-625-5018 giero002@umn.edu | |
| Australia | |
| 99 Commercial Road | Recruiting |
| Prahan Victoria, Australia, 3182 | |
| Contact: Vaughan G Macefield, BSc(Hons) PhD DSc FAAS +61 (0)426 581 647 vaughan.macefield@monash.edu | |
| Principal Investigator: | Vaughan G Macefield, PhD | Monash University | |
| Principal Investigator: | John Osborn | University of Minnesota |
| Responsible Party: | University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT06016686 |
| Other Study ID Numbers: |
VNS |
| First Posted: | August 30, 2023 Key Record Dates |
| Last Update Posted: | May 3, 2024 |
| Last Verified: | May 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |