Combined Minimally Invasive Vagal Cranial Nerve and Trigeminocervical Complex Peripheral Nerve Stimulation In Severe Painful Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Pain scores over time
研究概览
简要总结
This is an observational study that will follow patients in the course of routine care and measure pain levels, glucose assessments and drug utilization for native American patients with diabetic neuropathy
详细描述
Patients with diabetic neuropathy pain will have an NS100 device implanted for chronic diabetic neuropathy pain consistent with onlabel indication. All patients will be followed for 90 days post implant to measure improvements in pain, drug utilization and glucose levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic Neuropathy Pain History of failed treatment WIlling to follow blood glucose and pain scores for 90 days
- •Exclusion Criteria
- •Bleeding diathesis Pregnancy Cardiac monitoring device Implantable Neurostimulator Inability to give informed consedn
排除标准
- 未提供
研究组 & 干预措施
Native Americans with Diabetic Neuropathy Pain
Use of Trigeminal Vagus cervical nerve stimulation for diabetic neuropathy pain
干预措施: Implantation of a trigeminal Vagus cervical nerve stimulator system (Drug)
Native Americans with Diabetic Neuropathy Pain
Use of Trigeminal Vagus cervical nerve stimulation for diabetic neuropathy pain
干预措施: Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation (Device)
结局指标
主要结局
Pain scores over time
时间窗: 90 days
Periodic pain scores will be measured for 90 days and possibly longer
次要结局
- glucose levels will be measured over time(90 days)