NCT03976219终止不适用
Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion
Duke University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年6月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Evoked response amplitude for ECAPS
研究概览
简要总结
The purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age.
- •Subject is able and willing to comply with the schedule and protocol.
- •For implantation of DRG stimulator;
- •Subject has been diagnosed with complex regional pain syndrome (CRPS I or II).
- •Subject has had chronic, intractable pain of the groin or lower limbs for at least 6 months.
- •Subject is indicated for implantation of an Abbott DRG stimulation system.
- •Subject will be undergoing trial implantation of an Abbott DRG stimulation system.
- •For implantation of SCS;
- •Subject has been diagnosed with chronic, intractable pain of the trunk and/or limbs.
- •Subject is indicated for implantation of a SCS system.
- •Subject will be undergoing implantation of an Abbott lead.
- •Subject has had stable neurologic function in the past 30 days.
- •Subject is able to provide informed consent.
排除标准
- •Subject will be implanted with 3 or more DRG leads.
- •Subject is currently participating in a clinical investigation that includes an active treatment arm.
- •Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by physician examination.
- •Subject currently has an active implantable device including an ICD, pacemaker, spinal cord stimulator, or intrathecal drug pump.
- •Subject is a prisoner.
- •Female subject is pregnant.
结局指标
主要结局
Evoked response amplitude for ECAPS
时间窗: Visit 1, up to 2 hours
Evoked responses averaged across trials for ECAPS, measured in micro Volts
Pain level as measured by pain scale
时间窗: Visit 1, up to 2 hours
Measured on a scale 0 to 10, with 0 being no pain and 10 being pain as bad as you can imagine.
Evoked response amplitude for SSEPs
时间窗: Visit 1, up to 2 hours
Evoked responses averaged across trials for SSEPs, measured in micro Volts
次要结局
未报告次要终点
研究者
研究点 (2)
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