NCT06499220已完成不适用
Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 20
- 主要终点
- Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system.
研究概览
简要总结
This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years of age or older
- •Candidate for or undergoing Medtronic SCS device trial for labeled indication*
- •Willing and able to provide signed and dated informed consent
- •Capable of comprehending and consenting in English
- •Willing and able to comply with all study procedures and visits *Candidate for or undergoing Medtronic SCS device trial for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic SCS trialing to treat the patient's chronic pain. This decision is to be made prior to discussing with the patient whether to enroll in the study.
排除标准
- •Implanted electrical cardiac device (e.g., pacemaker, defibrillator)
- •Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)
- •Currently diagnosed with a disease that may confound ability to evoke compound action potentials, e.g. multiple sclerosis, as determined by the investigator
- •Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
- •Has untreated major psychiatric comorbidity, as determined by the investigator or designee
- •Trialed with a permanent implant lead and extension ("buried lead trial")
结局指标
主要结局
Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system.
时间窗: 1 hour to 72 hours
The ECAP data collected is prototype system/device information for development of a closed loop system.
次要结局
未报告次要终点
研究者
研究点 (20)
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