A Pilot Study of Auricular Vagus Nerve Stimulation on Cardiovascular Biomarkers and Glycemic Homeostasis in Persons With Chronic Spinal Cord Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of Treatment-related Adverse Events (AEs)
研究概览
简要总结
The purpose of this research is to test if Auricular Vagal Nerve Stimulation (aVNS) is safe in persons with spinal cord injury (SCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Chronic (equal or greater to 1 year) motor-complete and incomplete SCI Abbreviated Injury Scale (AIS) of A or B at the C5-T10 levels
排除标准
- •Pregnant or breastfeeding
- •Failure to satisfy inclusion criteria
- •Previous bariatric surgery
- •Active implantable devices (such as pacemakers)
- •Skin irritation or damage at the site (ear)
研究组 & 干预措施
aVNS followed by no aVNS in subjects with SCI
Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. In the following visit, subjects will complete all study assessments without the aVNS. Participation will be up to 2 weeks.
干预措施: auricular nerve stimulation (aVNS) (Device)
aVNS followed by no aVNS in subjects with SCI
Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. In the following visit, subjects will complete all study assessments without the aVNS. Participation will be up to 2 weeks.
干预措施: sham aVNS (Device)
no aVNS followed by aVNS in subjects with SCI
Subjects will complete all study assessments without the aVNS. In the following visit, Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. Participation will be up to 2 weeks.
干预措施: auricular nerve stimulation (aVNS) (Device)
no aVNS followed by aVNS in subjects with SCI
Subjects will complete all study assessments without the aVNS. In the following visit, Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. Participation will be up to 2 weeks.
干预措施: sham aVNS (Device)
结局指标
主要结局
Number of Treatment-related Adverse Events (AEs)
时间窗: Up to 2 weeks
Safety will be reported as the number of treatment-related AEs assessed by study PI or physician
Number of subjects that complete the study
时间窗: Up to 2 weeks
Safety will be determined by number of subjects that complete the two study, visits (in total, two weeks).
次要结局
未报告次要终点
研究者
Patrick Daniel Ganzer
Assistant Professor
University of Miami