NCT06588608
招募中
不适用
A Pilot Study of Auricular Vagus Nerve Stimulation on Cardiovascular Biomarkers and Glycemic Homeostasis in Persons With Chronic Spinal Cord Injuries
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Spinal Cord Injuries
- 发起方
- University of Miami
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of Treatment-related Adverse Events (AEs)
- 状态
- 招募中
- 最后更新
- 3个月前
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).
研究者
Patrick Daniel Ganzer
Assistant Professor
University of Miami
入排标准
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)
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).
研究点 (2)
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