Evaluation of Long-term Patient Experience With a Medtronic Closed-Loop Spinal Cord Stimulation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 14
- 主要终点
- Reduction in Overstimulation Sensation
研究概览
简要总结
The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.
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
- •18 years of age or older
- •Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs
- •If being treated for low-back and/or leg pain,
- •the baseline overall^ Visual Analog Scale is ≥ 60 mm and
- •baseline back and/or leg pain Visual Analog Scale is ≥60 mm. ^Average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using Visual Analog Scale.
- •If being treated for upper limb pain - baseline Visual Analog Scale is ≥ 60 mm for upper limb pain
- •On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial
- •Willing and able to provide signed and dated informed consent
- •Willing and able to comply with all study procedures and visits
排除标准
- •Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher
- •Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system
- •Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
- •Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator
- •Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator
- •Pregnant or planning on becoming pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal)
- •Be involved in an injury claim or under current litigation
结局指标
主要结局
Reduction in Overstimulation Sensation
时间窗: 30 days from device activation
The primary outcome is the proportion of low-back and/or leg pain subjects whose average overstimulation intensity score with Closed Loop On is less than their average overstimulation intensity score with Closed Loop Off. During in-clinic testing, subjects perform protocol prescribed activities and rate the intensity of the sensations on a 5-point Likert scale with both Closed Loop On and Off. The average overstimulation intensity scores within each subject are calculated separately for Closed Loop On and Off, and the proportion of subjects with a lower average overstimulation intensity score during Closed Loop On compared to their overstimulation intensity score during Closed Loop Off is calculated with a one-sided 97.5% lower bound.
次要结局
- Responder Rate for Treatment of Overall Pain(3 months from device activation)
- Responder Rate for Treatment of Low-back Pain(3 months from device activation)
- Responder Rate for Treatment of Leg Pain(3 months from device activation)