Microelectrode Recordings From the Vagus Nerve in Awake Humans
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VNS
participants with surgically implanted VNS electrodes to treat drug-resistant epilepsy
干预措施: VNS stimulation and intraneural recordings (Other)
non-VNS participants
participants without implanted VNS devices
干预措施: Record multi-unit activity from intraneural sites (Other)
结局指标
主要结局
identify action potential morphology of specific fibers activated by vagal nerve stimulation (VNS)
时间窗: 4 hours
assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module
physiological identification of the specific fibers activated by vagal nerve stimulation (VNS)
时间窗: 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 stimulus current required to activate specific fibers activated by vagal nerve stimulation (VNS)
时间窗: 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
时间窗: 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
时间窗: 4 hours
Vagal nerve stimulator device. Coefficient of variation, %
identify firing rates of the specific fibers activated by vagal nerve stimulation (VNS)
时间窗: 4 hours
assessing vagal nerve activity in epilepsy participants during and in the absence of stimulation. Labchart; spike histogram module. in Hertz
identify ratio of myelinated fibers in specific fibers activated by vagal nerve stimulation (VNS)
时间窗: 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.
次要结局
未报告次要终点