Microelectrode Recordings From the Vagus Nerve in Awake Humans

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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, air

Первичные конечные точки

• identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS) [Срок оценки: 4 hours]
• identify ratio of myelinated fibers in specific fibers activated by vagal nerve stimulation (VNS) [Срок оценки: 4 hours]
• physiological identification of the specific fibers activated by vagal nerve stimulation (VNS) [Срок оценки: 4 hours]
• identify firing rates of the specific fibers activated by vagal nerve stimulation (VNS) [Срок оценки: 4 hours]
• identify stimulus current required to activate specific fibers activated by vagal nerve stimulation (VNS) [Срок оценки: 4 hours]
• differences in firing rates of cardiac parasympathetic vagal activity [Срок оценки: 4 hours]
• Discharge variability of cardiac parasympathetic nerve fibers [Срок оценки: 4 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT06016686 · VNS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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