A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 44
- 主要终点
- Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System
研究概览
简要总结
The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 has chronic intractable pain of the trunk and/or limbs.
- •Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.
排除标准
- •Subject is unable to operate the system.
- •Subject is an unsuitable surgical candidate.
- •Subject has a condition currently requiring or likely to require the use of diathermy.
- •Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator.
- •Subject is <18 years old.
- •Subject is pregnant or nursing.
- •Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body.
- •Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).
结局指标
主要结局
Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System
时间窗: 12-months post-implant
Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3.
次要结局
未报告次要终点