NCT04909593已完成不适用
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Perception Threshold
研究概览
简要总结
The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).
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
- •Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU).
- •Subject signed a valid, EC/IRB-approved informed consent form.
- •Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained.
- •In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain.
排除标准
- •Subject meets any contraindication in BSC neurostimulation system local DFU.
- •Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy.
- •Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information.
- •Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.
研究组 & 干预措施
Spinal Cord Stimulation
Experimental
SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.
干预措施: Spinal Cord Stimulation (Device)
结局指标
主要结局
Perception Threshold
时间窗: Programming Visit (up to 15 days post-screening)
Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair
次要结局
未报告次要终点
研究者
研究点 (1)
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